The Life Sciences Report

Cleantech Co. Wins PFAS Deal, Engineering Pact, Ships Clyra

Thu, 21 May 2026 00:00:00 PST

Source: Richard Ryan 05/21/2026

BioLargo (BLGO:OTCQX) shipped Clyra's first stocking order, signed Aquatech PFAS MOU, and won a US$1.2M engineering contract for a minerals processing facility, according to an Oak Ridge Financial research note

On May 19, 2026, Richard Ryan and Sam Dufault, CFA of Oak Ridge Financial Research reiterated a Buy rating and a US$0.32 price target on BioLargo Inc. (BLGO:OTCQX), implying approximately 167% upside from the May 19, 2026 closing price of US$0.12, following 1Q26 results that included the first stocking order from Clyra Medical and several announcements demonstrating strategic positioning across the company's technology portfolio.

For 1Q26, BLGO reported revenues of US$1.1 million, compared with US$637,000 in 4Q25 and US$3.3 million in the year-ago quarter. The results continue to reflect the absence of any Pooph sales, with the brand still in litigation. The quarter included the first stocking order to Advanced Solutions within the Clyra Medical segment. Services revenues were US$538,000, up from US$466,000 a year ago, while product sales decreased 79% to US$577,000, almost entirely due to the decline in volume to private-label odor-control customer Pooph Inc. Total operating expenses were US$3.7 million versus US$3.4 million a year ago, with the operating loss widening to US$3.2 million from US$1.9 million on a ramp in Clyra-related expenses ahead of commercial launch. The net loss was US$3.4 million, or US$0.01 per share, compared with a net loss of US$1.9 million, or US$0.00 per share, a year ago. BLGO ended the quarter with US$4.1 million in cash and US$4.3 million in total debt, with cash usage from operations of US$2.9 million versus US$1.8 million a year ago. The analysts believe BLGO will continue to need additional capital.

During the quarter, Clyra issued guaranteed promissory notes totaling US$2.4 million bearing interest at 15% per annum and maturing February 28, 2029, guaranteed by BioLargo. BLGO sold 555,556 shares of common stock for US$100,000 in gross and net proceeds to one accredited investor, BETI sold 124,867 shares at US$3.70 per share to seven accredited investors for US$462,000, and BLGO sold 984,188 shares to Lincoln Park for US$171,000. As of May 14, 2026, BLGO had 320.9 million common shares outstanding.

On the strategic front, the engineering segment was awarded a US$1.2 million contract to design a pilot-scale minerals processing facility supporting remediation and beneficial reuse of a legacy mineral waste deposit, with potential for a multi-year remedial project. Clyra delivered on its first stocking order to Advanced Solutions and signed an exclusive distribution agreement with Al-Hikma FZCO covering the Gulf Cooperation Council, the Levant, North Africa, and select adjacent markets to commercialize ViaCLYR. Clyra's sales and distribution agreements are expected to make its products available to 6,100 hospitals, 6,300 ambulatory surgery centers, and 2,200 specialty wound care clinics in the U.S. alone. BLGO also signed a memorandum of understanding with Aquatech to advance integration and commercialization of BioLargo's proprietary Aqueous Electrostatic Concentrator (AEC) for PFAS treatment, establishing a non-exclusive framework for collaboration on PFAS treatment projects worldwide. BLGO's PFAS solution has a municipal drinking water project live in Stockholm, N.J., and the company recently announced the ability to remove ultrashort chain molecules to non-detect status while lowering energy usage for large-scale PFAS treatment. Separately, U.S. BESS Corporation's independent evaluation confirmed the breakthrough performance of BLGO's Cellinity battery technology for grid-scale energy storage; BLGO's strategy is to sell factories, not batteries, positioning it to receive a roughly 6% royalty and carried interest on projects.

The analysts highlighted several risks, including a lack of profitability with net losses since inception, significant ongoing cash requirements, potential going concern issues, revenue concentration in Pooph-branded products sold to Ikigai, regulatory approval timing, competition from better-resourced players, limited liquidity due to the OTC Markets listing, the potential for substantial future dilution, and reliance on third parties for commercialization.

The analysts described BLGO's diversified portfolio as giving the company "many shots on goal" and noted that "BLGO's reputation is rising." For 2026, they estimate revenues, EPS, and adjusted EBITDA of US$5.3 million, US$(0.04), and US$(11.3 million), versus prior estimates of US$3.6 million, US$(0.05), and US$(14.1 million). The US$0.32 base case price target is built on a FY26 sum-of-the-parts valuation using a 5.0x revenue multiple along with independent valuations of Clyra Medical (estimated at US$88 million, with BLGO's 48% ownership contributing US$0.13 per share) and the PFAS segment (a 3.5x revenue multiple on management's US$10 million 2026 revenue potential, yielding US$35 million or US$0.11 per share). The bull case adds US$0.13 per share from Cellinity, valued at US$44 million with BLGO's 96% ownership, resulting in a US$0.45 bull-case price target.

Important Disclosures:

BioLargo Inc. is a billboard sponsor of Streetwise Reports and pays SWR a monthly sponsorship fee between US$3,000 and US$6,000.
As of the date of this article, officers, contractors, shareholders, and/or employees of Streetwise Reports LLC (including members of their household) own securities of BioLargo Inc.
This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

Disclosures for Oak Ridge Financial Research, BioLargo Inc., May 19, 2026

Analyst Certification: Each authoring analyst of Oak Ridge Financial, whose name appears on the front page of this investment research, certifies that the views expressed in this report accurately reflect the authoring analyst’s personal views about the subject company and its securities. The authoring analysts also certify that they have not been, are not, and will not be receiving direct or indirect compensation related to the specific recommendations expressed in this report. Important Disclosures: The analysts or a member of his/her household does not hold a long or short position, options, warrants, rights or futures of this security in their personal account(s). As of the end of the month preceding the date of publication of this report, Oak Ridge Financial did not beneficially own 1% or more of any class of common equity securities of the subject company. There is not any actual material conflict of interest that either the analysts or Oak Ridge Financial is aware of. The analysts have not received any compensation for any investment banking business with this company in the past twelve months and does not expect to receive any in the next three months. Oak Ridge Financial has been engaged for investment banking or advisory services with the subject company during the past twelve months and does anticipate receiving compensation for such services in the next three months. Oak Ridge Financial has not served as a broker, either as agent or principal, buying back stock for the subject company’s account as part of the company’s authorized stock buy-back program in the last twelve months. No director, officer or employee of Oak Ridge Financial serves as a director, officer or advisory board member to the subject company. Oak Ridge Financial Rating System: Oak Ridge Financial utilizes a two-tier rating system for potential total returns over the next 12 months. Buy: The stock is expected to have total return potential of at least 15%. Catalysts exist to generate higher valuations and positions should be initiated at current levels. Investors requiring time to build positions may consider current levels attractive. Hold: The stock is expected to have total return potential of less than 15%. Fundamental events are not present to make it a Buy. The stock may be an acceptable longer-term holding. Valuation and Price Target Methodology: Clyra Medical and the Company’s PFAS technology provides investors with underlying support, while BLGO’s biggest “unseen value” opportunity offers investors an interesting “call option”, if you will. We are reaffirming a Buy rating and a $0.32 PT. Our PT is based on a FY26 Revenue multiple of 5.0x, which is in line with historical industry valuations and transactions, and an independent valuation of Clyra Medical and the Company’s PFAS technology. When considering our bull-case scenario, we believe Cellinity has proven itself as a viable technology based on 3rd-party validation. Recent valuations estimate Cellinity to be $44M which, at a 96% ownership to BLGO, would value the battery technology at $0.13 on a per share basis. We incrementally add this to our valuation, which results in a bull-case PT of $0.45.

Oak Ridge Financial does not make a market in the subject security at the date of publication of this report. Other Disclosures: The information contained in this report is based on sources considered to be reliable, but not guaranteed to be accurate or complete. Any opinions or estimates expressed herein reflect a judgment made as of this date and are subject to change without notice. This report has been prepared solely for informative purposes and is not a solicitation or an offer to buy or sell any security. The securities described may not be qualified for purchase in all jurisdictions. Because of individual requirements, advice regarding securities mentioned in this report should not be construed as suitable for all accounts. This report does not take into account the investment objectives, financial situation and needs of any particular client of Oak Ridge Financial. Some securities mentioned herein relate to small speculative companies that may not be suitable for some accounts. Oak Ridge Financial suggests that prior to acting on any of the recommendations herein, the recipient should consider whether such a recommendation is appropriate given their investment objectives and current financial circumstances. Past performance does not guarantee future results. Additional information is available upon request.

( Companies Mentioned: BLGO:OTCQX, )

Lexington, MA Biopharma Co. Reports Q1 2026 Financials, Makes R&D Plans

Wed, 20 May 2026 00:00:00 PST

Source: Streetwise Reports 05/20/2026

Keros Therapeutics Inc. (KROS:NASDAQ) lowered research spending & reported funding through 2028 as analysts monitor upcoming trial catalysts for ALS & Muscular Dystrophy drugs.

Keros Therapeutics Inc. (KROS:NASDAQ) released Q1 2026 financial results on May 14, 2026. Keros is a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients with disorders related to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins.

In the press release, the company's CEO and president, Dr. Jasbir S. Seehra, said: "Continuing to progress our pipeline remains our top priority, setting the stage for future catalysts and growth opportunities. In addition, we are excited that our partner, Takeda Pharmaceutical Co. Ltd. (TKPYY:OTCMKTS; 4502:TYO) ("Takeda"), plans to advance elritercept into a Phase 3 clinical trial to evaluate elritercept as a treatment of anemia in myelofibrosis, broadening the indication opportunity beyond myelodysplastic syndromes."

Highlights from Q1 2026 include:

A net loss of US$23.7 million in Q1 2026 compared to a net income of US$148.5 million in Q1 2025. The company said that this decrease is largely due to revenue recognized in 2025 due to Keros' license agreement with Takeda.
Research and development expenses (R&D) came in at US$16.1 million, compared to US$48.7 million for the same time last year. Takeda took on much of the elritercept-related research and development expenses.
General and administrative expenses were slightly down in Q1 2026, coming in at US$10.1 million compared to US$10.5 million in Q1 2025.
The company's cash and cash equivalents equaled US$281.5 million as of March 31, 2026, compared to US$287.4 million at the end of 2025.

While Keros is focused on several therapeutic drugs, "Keros' lead product candidate, rinvatercept, is being developed for the treatment of Duchenne muscular dystrophy and for the treatment of amyotrophic lateral sclerosis. Keros' most advanced product candidate, elritercept, is being developed for the treatment of cytopenias, including anemia and thrombocytopenia, in patients with myelodysplastic syndrome and in patients with myelofibrosis."

R&D Expenditures Declining

ALS and Muscular Dystrophy are genetic diseases causing skeletal muscles to progressively weaken and are fatal and incurable. In 2026, the U.S. government approved US$90 million for research into treatments and access to care for patients with ALS. While this is great news for patients, the pharma sector as a whole has slowed down on R&D spending.

\J. Edward Moreno of Sherwood News reported on January 14, 2026, that, "In 2025, announced global biotech deals totaled US$228.4 billion, up from US$132.3 billion in 2024, data from Dealogic shows . . . Just two weeks into 2026, US$9.2 billion in deals have been announced."

"As some of the most lucrative drugs lose exclusivity in the next few years, pharmaceutical giants are increasingly shopping around for biotechs to add to their portfolios — and they are more than happy to pay a hefty premium for the right company . . . For some Big Pharma companies, business development spending is now about equal to, or more than, research and development," Moreno went on to add.

Other news outlets are echoing this sentiment. On March 25, 2026, BioSpace's Annalee Armstrong reported that, "R&D spending at the top 16 pharmaceutical companies declined by 3.6% overall in 2025, as many aggressively cut spending and refocused pipelines."

Analysts Anticipate New Trial

A May 19, 2026, research report by Yun Zhong, Ph.D., for Wedbush gave Keros a "Neutral" rating, with a price target of US$16.00. Phase 2 of rinvatercept has been delayed from Q2 2026 to Q3 2026 due to operational and regulatory hurdles, causing Wedbush to pause on further evaluation. Zhong wrote, "We see rinvatercept as the main value driver for KROS, and we believe that the confirmation of a regulatory pathway forward will be needed for us to have stronger conviction in the long-term potential of the stock."

Andres Maldonado, Ph.D., of H.C. Wainwright & Co. chose to give the company a "Buy" rating on May 15, 2026. With a price target of US$20, Maldonado said, "The stock . . . needs a clean trial start, credible endpoint strategy, and early evidence that the body composition, bone, fat, inflammation, and functional biomarker changes can translate into patient-level benefit."

Maldonado went on to say, "We view Keros as having enough cash to execute through the next major value-inflection windows, but the equity story is now tightly levered to proving that rinvatercept's elegant biology can move beyond healthy volunteer pharmacology and generate interpretable patient-level benefit in neuromuscular disease." [OWNERSHIP_CHART-10676]

Company Funded Through 2028

Keros expects that its cash and cash equivalents as of March 31, 2026, will enable the company to fund its operating expenses and capital expenditure requirements into the first half of 2028.

According to the company's investor presentation, a Q3 trial for rinvatercept is planned.

Ownership & Share Information¹

Keros Therapeutics Inc. has a market cap of US$196.14 million, with 19.79 million shares outstanding. The company's 52-week range is US$9.79-US$22.55.

Institutions own 96.39% of shares, while Strategic Investors own 1.27%.

Management & Insiders own 2.34% of shares.

Important Disclosures:

Cori Fisher wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee.
This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

1. Ownership and Share Structure Information

The information listed above was updated on the date this article was published and was compiled from information from the company and various other data providers.

( Companies Mentioned: KROS:NASDAQ, )

Lexington, MA Biotech Pushes DMD Phase 2 Start to 3Q26 on Regulatory Hurdles

Wed, 20 May 2026 00:00:00 PST

Source: Dr. Yun Zhong 05/20/2026

Keros Therapeutics (KROS:NASDAQ) disclosed that initiation of its Phase 2 rinvatercept study in Duchenne muscular dystrophy will slip from 2Q26 to 3Q26 due to procedural regulatory delays, according to a Wedbush research note.

On May 19, 2026, analyst Yun Zhong of Wedbush Securities reiterated a Neutral rating and US$16.00 price target on Keros Therapeutics Inc. (KROS:NASDAQ), implying meaningful upside from the recent closing price of US$10.16, following the company's 1Q26 earnings release and an update indicating that the Phase 2 study initiation in Duchenne muscular dystrophy (DMD) has been pushed from 2Q26 to 3Q26 due to regulatory delays.

The 1Q26 press release disclosed that partner Takeda Pharmaceutical Co. Ltd. (TAK:NYSE; 4502:TYO) plans to advance elritercept into a Phase 3 study in patients with anemia associated with myelofibrosis (MF). On Keros's wholly-owned program rinvatercept (KER-065), the 10-Q indicated that Phase 2 initiation in DMD will now occur in 3Q26 versus prior guidance of 2Q26, while plans to discuss the design of a new Phase 2 study in amyotrophic lateral sclerosis (ALS) with regulators in 2H26 remain unchanged. Keros ended 1Q26 with total cash of US$281.5 million, and management reiterated guidance of a cash runway into 1H28.

Regarding the DMD delay, management communicated to Wedbush that the holdup is primarily tied to operational and regulatory hurdles, noting that the regulatory delays to date have been "procedural in nature, and are not specific to either KROS or rinvatercept." Management confirmed that progress is being made across all critical workstreams and that engagement with KOLs and physicians in the DMD community is ongoing. As a result of those interactions, Keros is incorporating changes to the study design intended to reduce patient burden, enhance recruitment, and facilitate study execution. Based on current plans, management believes that a 3Q26 study initiation will allow Keros to present initial data from the study in 1H27.

On the elritercept program, Zhong highlighted that the Takeda partnership announced in December 2024 includes a USUS$200 million upfront payment booked by Keros in 1Q25, total milestone payments of over USUS$1.1 billion, and tiered royalties ranging from low double digits to high-teens percentages of elritercept net revenues. A randomized, double-blind, placebo-controlled Phase 3 study in patients with very low, low, or intermediate risk myelodysplastic syndrome (MDS) requiring regular blood transfusions is ongoing (NCT06499285), with estimated completion in May 2028. A new open-label, randomized Phase 3 study comparing elritercept with epoetin alfa in the same patient population (NCT07422480) appears to have been initiated recently. In MF, an open-label Phase 2 study evaluating elritercept alone or in combination with ruxolitinib (NCT05037760) is ongoing.

Zhong's valuation is based on elritercept for anemia associated with MDS/MF, using discounted earnings, DCF, and clinical NPV models to derive the US$16 price target. Key risks to the rating and target include clinical risks tied to ongoing Phase 3 development, regulatory risks related to FDA and EMA approvals, manufacturing risks associated with reliance on third-party contract manufacturers, commercial execution risks at Takeda, competition risks from approved therapies including luspatercept with a similar mechanism of action, and financial risks given the need for additional capital to support KER-065 and other pipeline candidates.

Zhong maintained the Neutral rating even though the US$16 price target, based on the partnered elritercept program alone, already represents meaningful upside from current levels. Wedbush views rinvatercept as the main value driver for Keros and believes that "the confirmation of a regulatory pathway forward will be needed for us to have stronger conviction in the long-term potential of the stock."

Important Disclosures:

This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

Disclosures for Wedbush, Keros Therapeutics Inc., May 19, 2026

The analysts responsible for preparing research reports do not receive compensation based on specific investment banking activity. The analysts receive compensation that is based upon various factors including WS' total revenues, a portion of which are generated by WS' investment banking activities. Company Specific Disclosures This information is subject to change at any time. This research is provided for educational and informational purposes only and is not intended to be relied upon as a forecast, research, or investment advice, and is not a recommendation, offer, or solicitation to buy or sell any securities or to adopt any investment strategy. Investing involves risk, including the risk of loss of principal. Your investments may decline in value due to both real and perceived general market, economic, and industry conditions. Diversification does not ensure profits or protect against loss. This research was prepared without regard to specific investment objectives, strategies, tax status, investment horizon, financial situation or needs of any investor. Wedbush Securities, Inc. (“WSI”) encourages recipients of this report to read all relevant offering documents (e.g., prospectus) pertaining to any investment concerned, including without limitation, information relevant to its investment objectives, risks, and costs before making an investment decision and when deemed necessary, to seek the advice of a legal, tax, and/or accounting professional. Past performance is no guarantee of future results. Reliance upon information in this research is at the sole discretion of the reader. All information in this research is believed to be reliable as of the date on which this research was issued and has been obtained from public sources believed to be reliable. No representation or warranty, either express or implied, is provided in relation to the accuracy or completeness of the information contained herein. The opinions expressed are as of the date written and are subject to change without notice. In addition, this research may contain certain statements deemed to be “forward-looking” statements. All statements, other than historical facts, contained within this document that address activities, events or developments that this research report expects, believes, or anticipates will or may occur in the future are forward-looking statements. These statements are based on certain assumptions and analyses made by WSI in light of its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. Such statements are subject to assumptions, risks, uncertainties, many of which are beyond WSI’s control. Please note that any such statements are not guarantees of any future performance and that actual results or developments may differ materially from those projected in the forward-looking statements. Prepared by Wedbush Securities, Inc., a member of FINRA and SIPC. 1. WS makes a market in the securities of Keros Therapeutics, Inc.. Price Charts Keros Therapeutics, Inc. Rating History as of 05-18-2026 powered by: BlueMatrix 100 80 60 40 20 0 Jul 23 Oct 23 Jan 24 Apr 24 Jul 24 Oct 24 Jan 25 Apr 25 Jul 25 Oct 25 Jan 26 Apr 26 I:OP:$86.00 07/31/2023 I:OP:$84.00 11/04/2024 OP:$47.00 12/12/2024 N:$15.00 01/17/2025 N:$16.00 11/06/2025 Closing Price Price Target Outperform (OP); Neutral (N); Underperform (UP); Not Rated (NR)

Wedbush disclosure price charts are updated within the first fifteen days of each new calendar quarter per FINRA regulations. Price charts for companies initiated upon in the current quarter, and rating and target price changes occurring in the current quarter, will not be displayed until the following quarter. Additional information on recommended securities is available on request. Disclosure information regarding historical ratings and price targets is available: Research Disclosures *WS changed its rating system from (Strong Buy/ Buy/ Hold/ Sell) to (Outperform/ Neutral/ Underperform) on July 14, 2009. Applicable disclosure information is also available upon request by contacting the Research Department at (212) 833-1375, by email to leslie.lippai@wedbush.com. You may also submit a written request to the following: Wedbush Securities, Attn: Research Department, 142 W 57th Street, New York, NY 10019. OTHER DISCLOSURES The information herein is based on sources that we consider reliable, but its accuracy is not guaranteed. The information contained herein is not a representation by this corporation, nor is any recommendation made herein based on any privileged information. This information is not intended to be nor should it be relied upon as a complete record or analysis: neither is it an offer nor a solicitation of an offer to sell or buy any security mentioned herein. This firm, Wedbush Securities, its officers, employees, and members of their families, or any one or more of them, and its discretionary and advisory accounts, may have a position in any security discussed herein or in related securities and may make, from time to time, purchases or sales thereof in the open market or otherwise. The information and expressions of opinion contained herein are subject to change without further notice. The herein mentioned securities may be sold to or bought from customers on a principal basis by this firm. Additional information with respect to the information contained herein may be obtained upon request. Wedbush Securities does and seeks to do business with companies covered in its research reports. Thus, investors should be aware that the firm may have a conflict of interest that could affect the objectivity of this report. Investors should consider this report as only a single factor in making their investment decision. Please see pages 3–7 of this report for analyst certification and important disclosure information. Retail Investors The information provided is for general informational purposes only and should not be considered an individual recommendation or personalized investment advice. The companies/investments mentioned may not be suitable for everyone. Each investor needs to review their own respective situation(s) before making any investment decisions. All expressions of opinion are subject to change without notice due to shifting market(s), economic or political conditions. Investment involves risks including the risk of principal. Past performance is no guarantee of future results and the opinions presented cannot be viewed as an indicator of future performance.

( Companies Mentioned: KROS:NASDAQ, )

New York Digital Health Firm Expands Reach to 116 Million Covered Lives

Thu, 14 May 2026 00:00:00 PST

Source: Streetwise Reports 05/14/2026

DarioHealth Corp. (DRIO:NASDAQ) reported first quarter 2026 results showing sequential revenue growth, lower operating expenses, expanded channel partnerships and a US$127 million commercial pipeline.

DarioHealth Corp. (DRIO:NASDAQ) reported financial and operating results for the first quarter ended March 31, 2026, including sequential revenue growth, lower operating expenses, and expanded channel partner reach.

Revenue for the quarter totaled US$5.6 million, compared to US$5.2 million in the fourth quarter of 2025 and US$6.8 million in the first quarter of 2025. The company stated that the year-over-year decrease was primarily attributable to the non-recurrence of US$1.3 million in pharmaceutical customer revenue recognized during the prior-year period before transitioning away from one-time and non-recurring revenues toward annual recurring revenue from its core B2B2C business. Dario said the decline was partially offset by growth in channel partner revenues, including increased contributions from Solera, and continued expansion in direct-to-consumer musculoskeletal product sales.

The company reported GAAP gross profit of US$3.2 million for the quarter, compared to US$3.9 million in the prior-year period and US$2.8 million in the fourth quarter of 2025. Gross margin was 57% during the quarter, compared to 58% in the prior-year period and 54% in the fourth quarter of 2025.

Operating expenses were US$10.5 million for the quarter, down 21% year-over-year from US$13.3 million and down 8% sequentially from US$11.4 million. Dario stated that the decreases resulted mainly from increased operational efficiency. Operating loss for the quarter was US$7.3 million, compared to US$9.4 million in the first quarter of 2025 and US$8.6 million in the fourth quarter of 2025.

Cash and short-term deposits totaled US$20 million at March 31, 2026, while net cash used in operations was US$6 million, representing a 10% year-over-year decrease.

"The first quarter of 2026 was our second consecutive quarter of sequential revenue growth, alongside continued reductions in operating expenses," said Erez Raphael, Dario's Chief Executive Officer, in the company news release. Raphael added that Dario's channel partner ecosystem now provides access to more than 116 million covered lives through partners, including Solera and Amwell.

The company also stated that it is in the contracting phase with a new channel partner that, upon finalization, would expand Dario's reach to more than 175 million covered lives and add one of the largest hospital networks in the northeastern U.S. as a day-one anchor account.

Dario reported that DarioIQ™, its proprietary artificial intelligence layer operating on 13 billion real-world data points generated through FDA-cleared connected devices, showed continued performance during the quarter. According to the company, behavior-triggered engagement programs delivered up to a 40% improvement in member retention and up to a 57% increase in active sessions versus control groups.

Steven Nelson, Dario's President and Chief Commercial Officer, stated in the release, "Our channel-led commercial model is producing the compounding effect we built it for." Nelson added that Dario added 10 new accounts during the first quarter, all outside the normal benefit cycle, and referenced several contracted enterprise implementations expected during the second half of the year.

Digital Therapeutics and Digital Health Markets Continued Expanding Across Chronic Care and Mental Health Applications

According to Statista Market Insights, the worldwide Digital Therapeutics market experienced growth driven by demand for alternatives to pharmaceutical treatment and expanding healthcare technologies. The report stated that "customers are increasingly seeking non-pharmaceutical treatment options for various health conditions" and were looking for "personalized and convenient solutions that can be accessed from the comfort of their own homes."

Statista also wrote that one of the primary industry developments involved technology integration, stating that "one of the major trends in the digital therapeutics market is the integration of artificial intelligence (AI) and machine learning (ML) technologies." The report added that these technologies enabled "the development of personalized treatment plans and predictive analytics," while also citing "a growing trend towards the use of virtual reality (VR) and augmented reality (AR) in digital therapeutics."

The report further noted that chronic disease management remained a central factor across the sector. According to Statista, "the increasing prevalence of chronic diseases, such as diabetes and cardiovascular diseases, is a key macroeconomic factor driving the growth of the digital therapeutics market." The publication stated that these conditions required long-term management and that digital therapeutics offered "a cost-effective and scalable solution."

According to a Digital Health Market report covering the 2026 through 2033 period, the global digital health market reached an estimated US$347.4 billion in 2025. The report stated that growth had been supported by "a strong domestic digital health market for telehealthcare platform developers, mHealth app providers, wearable device manufacturers, and e-prescription systems." It also reported that North America accounted for 37.1% of the market share in 2025, while software represented the largest component segment at 45.7%.

The digital health report also highlighted trends in chronic care and remote patient management. According to the publication, "the rising incidence of chronic conditions such as diabetes, heart disease, and cancer is fueling the demand for remote monitoring and management solutions." It added that "digital tools such as wearable devices and connected sensors allow patients to track vital signs, blood sugar levels, or other critical data in real-time."

The report also cited funding activity within the sector. According to data from ROCK HEALTH referenced in the publication, U.S. digital health startups secured US$10.1 billion in funding across 497 deals during 2024. The report stated that "the healthcare industry exhibits high growth potential for the IT industry due to supportive government initiatives across all regions."

The Business Research Company wrote in its January digital mental health market report that the digital mental health market reached US$27.55 billion in 2025. The report stated that "digital mental health refers to the utilization of digital health technology for the assessment, support, prevention, and treatment of mental health issues."

According to The Business Research Company, market growth has been associated with several factors, including "increasing awareness of mental health, adoption of telehealth services, limited accessibility to traditional therapy, rise in smartphone usage, and development of early digital mental health tools." The report also stated that "the growing prevalence of mental disorders is expected to propel the growth of the digital mental health market going forward."

The report highlighted increased use of AI-enabled technologies within the space, stating that companies had increased their focus on "innovations in AI and machine learning algorithms to gain a competitive edge in the market." It added that these technologies were being used in "organizing mental health services and detecting, along with analyzing mental health issues."

Analysts Point to Revenue Growth and Commercial Pipeline Momentum

In an April 24 report, Litchfield Hills Research LLC stated that it was "dropping coverage of DarioHealth Corp due to the reallocation of analyst coverage." The firm noted that its "previous rating had been Buy" and that its "previous price target had been US$20."

According to an April 27 report from ThinkEquity analyst Ashok Kumar, PhD, CFA, the firm maintained its "BUY" rating and US$25.00 price target on DarioHealth Corp. Kumar wrote that "the reported evidence still supports a constructive, but risk-adjusted, view." He added that "2025 results and subsequent disclosures show lower operating expense, higher gross margin, and a larger signed and late-stage commercial base than the equity appears to credit."

The ThinkEquity report stated that Dario's 2025 Form 10-K reported revenue of US$22.4 million compared to US$27.0 million in 2024, while management attributed the decline to "a scope change and non-renewal from one legacy Twill client." Kumar also wrote that Dario signed 85 agreements in 2025, identified US$12.9 million of contracted and late-stage ARR expected to contribute in 2026 and 2027, and ended the year with a US$122 million pipeline.

Kumar stated that "the platform case is strongest when limited to reported metrics" and noted that the 2025 Form 10-K showed "57% GAAP gross margin, up from 49% in 2024." The report also referenced disclosures from the March 19 earnings materials and April 2026 investor presentation stating that "the core B2B2C recurring business has sustained roughly 80% non-GAAP gross margin."

In the April 27 report, Kumar wrote that "the long case rests on a structural shift away from narrower point-solution selling and toward an employer, health-plan, and channel model built around multi-condition deployments." He added that management disclosed that "the majority of new 2025 contracts were for multi-condition platforms and that more than 70% of pipeline opportunities were multi-condition."

The ThinkEquity report also discussed Dario's commercial pipeline and channel activity. Kumar wrote that "Dario's commercial pipeline reached US$122 million as of December 31, 2025, across 230 opportunities, with more than 70% of pipeline opportunities described as multi-condition." The report further stated that management discussed "ramp timing for relationships involving Florida Blue, Amwell, HCSC, and Solera."

Regarding financial position, Kumar stated that "the balance sheet remains the core discount." The report noted that the company reported US$21.8 million of cash and cash equivalents, US$2.2 million of short-term bank deposits, and US$30.7 million of long-term loan obligations at December 31, 2025. Kumar added that "execution risk remains the dominant issue" and stated that "partner access and covered lives must still translate into enrolled members, renewal dollars, and recognized revenue."

The ThinkEquity report concluded, "We maintain BUY and US$25.00 because we think the core factual setup is better than it was a year ago: reported operating expense is lower, gross margin is higher, the evidence package is broader, and the company has disclosed enough signed and late-stage commercial activity to support a reasonable growth bridge if even part of it converts on schedule."

In a May 12 company update, CG Capital maintained its "Outperform" rating and US$28.00 price target on DarioHealth Corp. The report stated that DarioHealth reports first quarter 2026 results on May 13, 2026, and framed the quarter as "a quarterly checkpoint on three operating signals coming out of the FY2025 plan: sequential revenue progression off the US$5.2M Q4 2025 base, OpEx discipline against management's guided ~30% non-GAAP operating loss reduction for 2026, and the early indicators of pipeline conversion as the 85 enterprise client wins from 2025 begin implementation."

CG Capital wrote that "Q4 2025 revenue of US$5.2M was the first sequential improvement after the Twill-era client non-renewal headwind" and stated that management had confirmed on the March 19 year-end call that "sequential growth is continuing into Q1 2026."

The May 12 report stated that DarioHealth had "consolidated four formerly separate digital health businesses (diabetes, hypertension, MSK, behavioral health) onto a single technology and commercial chassis under the DarioIQ AI architecture." CG Capital added that "the platform now addresses 6+ chronic conditions across a single member experience with 100+ peer-reviewed studies."

CG Capital also wrote that "against a 40-client target, DarioHealth signed 85 enterprise agreements in 2025 — more than doubling the objective." The report referenced channel and health-plan relationships, including Aetna/CVS, UnitedHealthcare, and Florida Blue.

The report further stated that "cash flow breakeven targeted for mid-2027" had been extended from prior guidance and that "non-GAAP OpEx targeting ~$31–33M by Q4 2026." CG Capital added that "the commercial pipeline expanded to US$122M (200+ B2B2C opportunities), and 85 client agreements were signed in 2025 versus a 40-client target."

CG Capital stated that its US$28.00 price target was based on a "probability-weighted blend of three scenarios." The report said, "We maintain our Outperform rating and US$28.00 price target," while noting that "our investment thesis rests on three interlocking pillars: commercial inflection, strategic optionality, and margin transformation."

Commercial Expansion and Pipeline Activity

According to the company, Dario added 10 new accounts during the first quarter of 2026, all outside the normal benefit cycle, and reported an approximately US$127 million pipeline across 241 active potential opportunities.

The April 2026 corporate presentation stated that Dario's channel partnerships provide access to approximately 116 million covered lives through partners including Solera, Amwell, Personify Health, OneStep, Allegiance, and GreenKey.

The presentation also stated that Dario signed 85 new accounts during 2025, bringing its total client count to more than 160, while approximately 70% of new contracts and pipeline opportunities were multi-condition.

According to the presentation, the company reported US$12.9 million in contracted and late-stage annual recurring revenue expected to contribute revenue during 2026 and 2027, along with a US$122 million pipeline consisting of 233 primarily B2B2C annual recurring revenue opportunities. [OWNERSHIP_CHART-9981]

The presentation outlined employer pipeline opportunities totaling US$54 million, including 44 new employer opportunities representing US$35 million in pipeline value during 2026 and 58 new employer opportunities representing US$19 million in pipeline value during 2027. It also outlined health plan pipeline opportunities totaling US$60 million, including 70 new health plan opportunities representing US$33 million in pipeline value during 2026 and 11 opportunities representing US$27 million in pipeline value during 2027.

Dario's April 2026 presentation stated that its platform addresses more than six chronic conditions, including diabetes, hypertension, weight management, musculoskeletal health, behavioral health, GLP-1 support, sleep apnea, and maternal health.

The company also reported that its multi-condition platform operates across cardiometabolic, behavioral health, and musculoskeletal care categories, supported by AI-powered coaching, connected devices, digital tools, and behavioral change programs.

Ownership & Share Information¹

DarioHealth Corp. has a market cap of US$54.17 million, with 7.30 million shares outstanding.

The company's 52-week range is US$5.94-US$17.74.

Institutions own 10.53% of shares, while Strategic Investors own 9.88%.

Management & Insiders own 11.24% of shares, and the remaining 68.35% of shares are held by Retail.

Important Disclosures:

James Guttman wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee.
This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

1. Ownership and Share Structure Information

The information listed above was updated on the date this article was published and was compiled from information from the company and various other data providers.

( Companies Mentioned: DRIO:NASDAQ, )

Biotech Co. Unveils Scalable AI Voice Biomarker Platform

Wed, 13 May 2026 00:00:00 PST

Source: Streetwise Reports 05/13/2026

MindBio Therapeutics Corp.'s (MBIO:CSE; MBQIF:OTCQB; WF6:Frankfurt) CEO says proprietary AI voice analytics could transform impairment screening across zero-tolerance industries.

MindBio Therapeutics Corp. (MBIO:CSE; MBQIF:OTCQB; WF6:Frankfurt) is developing a diagnostic platform that uses AI and voice analysis to identify intoxication or exhaustion from human speech. By analyzing vocal patterns as indicators of physiological and cognitive function, the company aims to create a detection system capable of recognizing impairment caused by a variety of substances. The technology aims to improve current detection methods, becoming a diagnostic tool that could reshape regulatory compliance, workplace safety, and public health monitoring.

In a May 12, 2026, interview with IBN, MindBio CEO Justin Hanka discussed the software, saying, "The human voice and our speech are a remarkable indicator of what's going on inside the body. It's a non-invasive way of predicting and detecting internal health and disease states. Over the last many years, we've been doing drug and alcohol research and collecting a lot of speech and voice data, and as machine learning and AI technologies have advanced, we're able to detect what's going on in the body — particularly drug and alcohol intoxication — just by analyzing the voice."

Hanka went on to say, "As high as 25% of workplace accidents are caused by drug and alcohol intoxication either directly or indirectly. . . It's very difficult to stop thousands of employees coming on-site, so these companies currently have a random testing protocol. We'll be able to dramatically increase the rate at which testing is done on site, at the gate, or randomly throughout the workplace."

Current screening techniques in zero-tolerance industries can be invasive, time-consuming, costly, and make a worker appear targeted. MindBio aims to provide the benefits of screening without the pitfalls. "The core reason why a company wants to do this is that 25% of incidents are caused by alcohol and drug intoxication, directly or indirectly," Hanka said in an interview with Streetwise Reports.

When questioned about how the technology might interpret different languages, dialects, or speech patterns, Hanka said, "It's language agnostic. It's accent agnostic," noting that the markers tested change uniformly with intoxication, regardless of gender, dialect, or language. The application of this AI system allows for the potential to administer tox screenings in a non-discriminatory and scalable way.

The company hopes to help create ". . . a world where voice-based biomarkers are a standard component of healthcare — enabling continuous, passive health monitoring that catches problems early and improves outcomes for everyone, everywhere" and describes its vision as developing ". . . a world where voice-based biomarkers are a standard component of healthcare—enabling continuous, passive health monitoring that catches problems early and improves outcomes for everyone, everywhere."

A Dangerous Sector in Need

MindBio recently stated that screening for drug and alcohol intoxication at scale can prevent unnecessary harm through the detection of physiological decline. The company offered statistics that estimate a 10-20x increase in suicide risk while heavily intoxicated. It also claims that 40-50% of suicides involve alcohol, noting that the global alcohol harm cost sits at around US$1.6 trillion.

The risk of addiction and drug or alcohol abuse rises due to many factors, like parental monitoring, peer pressure, socioeconomic status, type of substance, stress, drug availability, and occupation, according to the American Addiction Centers. They cite the mining industry as "particularly conducive to substance abuse," due to job stress, physical demand, and injuries from prolonged work.

The entire biotech sector has shown exponential growth recently. "The global biotechnology market size was estimated at US$1.55 trillion in 2023 and is projected to reach US$3.88 trillion by 2030, growing at a CAGR of 13.96% from 2024 to 2030," said Grandview Research. In September 2025, Market and Market Analysis considered the AI detector market as "undergoing rapid expansion, with estimates projecting a substantial market value surge from approximately US$0.58 billion in 2025 to US$2.06 billion in 2030."

Experts Expecting Positive Results

On February 3, 2026, The Canadian Mining Journal reported that, "Studies in Chile reveal that alcohol consumption among mining workers exceeds 75%, with over 40% classified as problem drinkers." The article noted the potential efficacy of MindBio's kiosks in accident prevention, saying, "A single preventable incident can cost a mining company hundreds of millions in lost production, union boycotts, and insurance and medical expenses." [OWNERSHIP_CHART-11539]

Knowlton Thomas, for Techcouver, wrote on January 26, 2026, that ". . . Leveraging more than 50 million data points from drug and alcohol clinical trials and proprietary algorithms across over 100 acoustic parameters, MindBio is now commercializing its technology."

¹Most recently, Stewart Thomson gave Streetwise Reports a contributed technical analyst opinion about MindBio on April 1, 2026. Thomson rated MindBio as a 'Strong Speculative Buy', with a short-term price target of CA$1.70, a medium-term price target of CA$3.00, and a long-term price target of CA$6.00.

Multiple Sectors Under Development

Currently, MindBio is creating inroads into the mining, aviation, construction, and law enforcement industries.

According to the company's latest presentation, MindBio intends to deploy its Edge AI voice drug and alcohol detection kiosks for the mining and aviation sectors in June 2026, hoping to test at a large scale in zero-tolerance industries. The company is already partnering with mines in South America and is in talks with other industries.

While enterprise and telehealth capacities are in development right now, future plans include disease prediction and health optimization.

Ownership & Share Information²

MindBio Therapeutics Corp. has a market cap of CA$7.9 million, with 7.28 million shares outstanding. The company's 52-week trading range is CA$0.50-CA$8.00. Management and Insiders own approximately 5.80% of MindBio Therapeutics shares, with Retail investors holding the remaining 94.20%.

Important Disclosures:

Important Disclosures:

MindBio Therapeutics Corp. is a billboard sponsor of Streetwise Reports and pays SWR a monthly sponsorship fee between US$3,000 and US$6,000.
As of the date of this article, officers, contractors, shareholders, and/or employees of Streetwise Reports LLC (including members of their household) own securities of MindBio Therapeutics Corp.
Cori Fisher wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee.
This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

1. Disclosure for the quote from the Stewart Thomson article published on April 1, 2026

For the quoted article (published on April 1, 2026), MindBio Therapeutics Corp. has paid Street Smart, an affiliate of Streetwise Reports, US$3,500.
Author Certification and Compensation: Stewart Thomson was retained and compensated as an independent contractor by Street Smart for writing this article. Mr. Thomson is a retired Canadian financial advisor who has passed the Canadian Securities Course as well as additional technical analysis courses that were mandated by his former employer and approved by Ontario regulatory bodies. For the past 15 years, he has been editing and writing numerous financial newsletters that have a strong focus on charts. The recommendations and opinions expressed in this content reflect the personal, independent, and objective views of the author regarding any and all of the companies discussed. No part of the compensation received by the author was, is, or will be directly or indirectly tied to the specific recommendations or views expressed.

For additional disclosures, please click here.

2. Ownership and Share Structure Information

The information listed above was updated on the date this article was published and was compiled from information from the company and various other data providers.

( Companies Mentioned: MBIO:CSE; MBQIF:OTCQB; WF6:Frankfurt, )

FDA Fast Track Designation Boosts ALS Treatment Outlook; Analyst Sees More Than 250% Upside Potential

Tue, 12 May 2026 00:00:00 PST

Source: Jason Kolbert 05/12/2026

D. Boral Capital analyst Jason Kolbert reiterated his rating and price target on Coya Therapeutics Inc. (COYA:NASDAQ) following the company's receipt of FDA Fast Track Designation for COYA 302 in ALS.

On May 12, 2026, analyst Jason Kolbert of D. Boral Capital reiterated a Buy rating and US$15.00 price target on Coya Therapeutics Inc. (COYA:NASDAQ), implying upside from the May 11, 2026, closing price of US$4.18, following the company's receipt of U.S. FDA Fast Track Designation for COYA 302 in amyotrophic lateral sclerosis (ALS).

Kolbert characterized the designation as an incremental regulatory positive that should support more frequent FDA engagement and potentially streamline review if the Phase 2 ALSTARS program generates supportive data. While the designation does not change the clinical risk profile, it reinforces the unmet need in ALS and validates COYA 302 as a program potentially eligible for a more efficient development and review path.

COYA 302 is a dual immunomodulatory therapy combining proprietary low-dose IL-2 with CTLA-4 Ig, designed to restore and enhance regulatory T cell (Treg) anti-inflammatory function while suppressing inflammatory activity from activated monocytes and macrophages. According to the report, this approach targets the underlying immune dysregulation and chronic inflammation believed to drive ALS progression, differentiating it from most approved or late-stage ALS therapies that primarily focus on neuronal protection or symptom management rather than actively rebalancing the immune system.

The key focus remains execution of ALSTARS, the ongoing Phase 2 randomized, multicenter, double-blind, placebo-controlled trial evaluating COYA 302 in ALS. The study is expected to be conducted across roughly 20-25 sites in the U.S. and Canada, with the next meaningful inflection points being enrollment progress, safety updates, and ultimately efficacy data sufficient to support a clearer regulatory path.

Looking ahead, Kolbert highlighted several catalysts for investors to monitor, including continued ALSTARS enrollment updates, any additional FDA feedback following Fast Track designation, potential expansion of COYA 302 into frontotemporal dementia following the accepted IND, and future data that could clarify whether Treg-enhancing therapy can produce a clinically meaningful benefit in ALS.

On the financial side, Coya reported total revenues of US$8 million in 2025, with estimates of US$0 million in 2026 and US$15 million in 2027. Total expenses were US$31 million in 2025, projected at US$30 million in both 2026 and 2027. GAAP EPS was US(1.27) in 2025, with estimates of US(1.27) in 2025, US (1.56) in 2026, and US(0.65) in 2027. $The company has a market capitalization of US$98 million, an enterprise value of US$23 million, a book value of US$2.37, cash of US$28 million, and a quarterly burn rate of US (4) million.$ The 52-week range is US$3.94–US$7.75 with an average daily volume of 144,000 shares.

To arrive at the US$15.00 12-month price target, Kolbert modeled Coya's lead therapy COYA-302 in ALS, applying a probability of success factor of just 15% in addition to a discount rate of 30%, while assuming additional capital will be raised in the final share count. These projections were applied to Free Cash Flow to the Firm (FCFF), discounted EPS (dEPS), and sum-of-the-parts (SOP) models, which were equal-weighted, averaged, and rounded to the nearest whole number.

Risk factors identified in the report include Clinical and Regulatory Risk, Partnership Risk, Financial Risk, Commercial Risk, Legal and Intellectual Property Risk, and Market Share Risk.

Important Disclosures:

This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

Disclosures for D. Boral Capital, Coya Therapeutics Inc., May 12, 2026

Analyst Certification I, Jason Kolbert, certify that all of the views expressed in this research report accurately reflect my personal views about the subject security(ies) and subject company(ies). I also certify that no part of my compensation was, is, or will be, directly or indirectly, related to the specific recommendations or views expressed in this research report. Company-Specific Disclosures General Disclosures The information contained in Research Reports or other Research products produced by D. Boral Capital LLC is for informational purposes only and does not constitute solicitation of the sale or purchase of securities or other investments. The information in such products is derived from sources that are believed to be reliable. Prices, numbers, and similar data include past results, estimates, and forecasts, all of which may differ from actual data. These prices, numbers, and similar data may also change without prior notification. D. Boral Capital holds the copyright on this research report. Any unauthorized use or transmission of any part of this research report for any reason, whether by digital, mechanical, or any other means, is prohibited. If you have any questions, please contact your sales representative. Additional information is available upon request. Certain company names, product and/or service names that appear in this research report are trademarks or registered trademarks of D. Boral Capital or other companies mentioned in the report. Copyright 2026 D. Boral Capital LLC. D. Boral Capital rating definitions are expressed as the total return relative to the expected performance of S&P 500 over a 12-month period. BUY (B) - Total return expected to exceed S&P 500 by at least 10% HOLD (H) - Total return expected to be in-line with S&P 500 SELL (S) - Total return expected to underperform S&P 500 by at least 10% Distribution of Ratings/IB Services D. Boral IB Serv./Past 12 Mos. Rating Count Percent Count Percent BUY 39 86.67 13 33.33 HOLD 6 13.33 0 0.00 SELL 0 0.00 0 0.00

( Companies Mentioned: COYA:NASDAQ, )

California Biotech Co. Discovers VOXZOGO Breakthrough, Reports Strong Q1

Mon, 11 May 2026 00:00:00 PST

Source: Streetwise Reports 05/11/2026

BioMarin Pharmaceuticals Inc. (BMRN:NASDAQ) delivered positive long-term achondroplasia data alongside rising revenues, accelerating rare disease portfolio growth.

Since the start of May 2026, BioMarin Pharmaceuticals Inc. (BMRN:NASDAQ) has released two significant pieces of news. On May 2, BioMarin presented at the Pediatric Endocrine Society's 2026 annual meeting, offering new data on the effects of long-term usage of its drug, VOXZOGO (vosoritide). The drug is designed to treat Achondroplasia, and the study saw a positive impact on patient arm span and bone density.

Achondroplasia is the most common form of skeletal dysplasia and leads to disproportionate short stature. It is characterized by the slowing of endochondral ossification, which causes disordered architecture in the long bones, face, spine, and skull. Over 80% of patients with this condition have no hereditary history, spontaneously developing a change in the FGFR3 gene, which regulates bone growth.

Results showed that "arm span Z-scores improved from baseline in all age groups, and the arm span-to-height ratio also remained stable over time, showing treatment resulted in proportional skeletal growth. Children who initiated treatment with VOXZOGO after age 5 also achieved a mean difference in standing height of 10.60 cm after six years of treatment (p<0.0001) and 13.59 cm after eight years of treatment (p<0.0001), compared with untreated natural history cohorts."

M.D. and Ph.D. Bradley Miller, a pediatric endocrinologist at the University of Minnesota, spoke of the study results, saying, "With VOXZOGO, we now have a depth and duration of evidence that is unmatched in the treatment of achondroplasia — providing meaningful insight not only into growth, but into the broader, sustained impact on a child's health. When you can see consistent benefits over time, it gives you greater confidence to intervene early and treat with purpose."

The company also released the results of a study focused on the impact of long-term treatment of 119 children on their bone mineral content and bone mineral density every year for six years. Results showed either improvement or consistency year over year.

In a statement, Greg Frieberg, MD., Executive Vice President and Chief Research & Development Officer at BioMarin, said, "We are committed to understanding and sharing the clear impact of long-term treatment with VOXZOGO on health measures beyond height, including arm span and bone density, that are meaningful to the thousands of children around the world receiving this medicine. With more than ten years of clinical research now, we have seen again and again a breadth of data that continues to demonstrate that long-term and early treatment are critical to ensure the greatest benefit in children with achondroplasia."

2026 Financial & Operational Results

On May 5, 2026, BioMarin released Q1 2026 financial and operating cost results. President and CEO, Alexander Hardy, opened the release by saying, "With the acquisition of Amicus Therapeutics complete, the addition of GALAFOLD and POMBILITI + OPFOLDA to our commercial portfolio allows us to reach patients with Fabry and Pompe diseases and meaningfully strengthens and accelerates our near-to-mid-term growth rates. We expect these high-growth assets to support our strongest financial performance yet in 2026. Next quarter, we look forward to updating you on the long-term outlook of the Amicus integration based on our plans to leverage our global scale to expand the potential of these transformative therapies. With a faster-growing commercial portfolio, together with two near-term Phase 3 data readouts and ongoing pipeline progress expected over the coming quarters, we are well-positioned to drive innovation, create shareholder value, and improve outcomes for patients worldwide."

BioMarin listed Q1 2026 financial highlights as follows:

Total Revenues for the first quarter of 2026 were US$766 million, an increase of US$21 million compared to the same period in 2025, primarily driven by the timing of large government orders outside the U.S. and an increase in patient demand for Enzyme Therapies (ALDURAZYME^®, BRINEURA, NAGLAZYME, PALYNZIQ, and VIMIZIM) as well as new patients initiating VOXZOGO therapy across all regions. The increase was partially offset by lower ROCTAVIAN^® revenue attributed to the voluntary withdrawal of the product from the market announced in the first quarter of 2026.
GAAP Net Income for the first quarter of 2026 decreased to US$106 million compared to US$186 million for the same period in 2025. The decrease in GAAP Net Income was primarily attributed to the following:

Higher Selling, General & Administrative (SG&A) spend primarily due to incremental administrative costs related to ongoing support of corporate initiatives and pre-close costs for Amicus acquisition, and higher sales and marketing spend on VOXZOGO, PALYNZIQ and VIMIZIM;
Higher Cost of Sales primarily due to a US$31 million charge associated with an unsuccessful process qualification campaign to expand NAGLAZYME manufacturing capabilities;
Higher Research and Development spend to support BMN 401, a late-stage clinical program acquired in the third quarter of 2025;
Partially offset by revenue growth as mentioned above.

Non-GAAP Income for the first quarter of 2026 decreased to US$149 million compared to US$221 million for the same period in 2025. The decrease in Non-GAAP Income was primarily due to the factors noted above.
GAAP Diluted Earnings per Share (EPS) and Non-GAAP Diluted EPS for the first quarter of 2026 decreased compared to the same period in 2025, primarily reflecting the discrete items and higher operating expenses described above.

BioMarin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the San Rafael, California-based company has a proven track record of innovation, with a portfolio of commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that have a profound impact on patients.

Enzyme Replacement Therapy: A Growing Sector

"The global enzyme replacement therapy market size is calculated at USD 10.4 billion in 2024, grew to USD 11.34 billion in 2025, and is projected to reach around USD 24.71 billion by 2034," reported Towards Healthcare on April 21, 2026. The rising prevalence of genetic disorders, paired with better diagnostics and development activities, could expand the market at a CAGR of 9.04% by 2034. Enzyme Replacement Therapy (ERT) replaces a missing or damaged enzyme in a patient's body in order to treat a disease and is used to treat rare genetic disorders. The article went on to say that, "ERT is being studied to treat cancer, neurodegenerative diseases, joint problems, inflammation, and infections."

In February 2026, Iqvia discussed the global pharma market projection for 2026, noting that total drug usage is expected to surpass four trillion doses daily by 2030. They wrote, "The largest drivers of medicine spending growth through the next five years will continue to be the use in developed markets of innovative therapeutics, especially in oncology, immunology, diabetes, and obesity."

BCG talked about trends biopharma companies need to be aware of in 2026 in order to stay competitive, saying, "Near term, companies need to continue to innovate to decrease the complexity and cost of these therapies, and governments can find ways to incentivize and pay for them. The longer-term challenge for companies is to factor operational and economic considerations into R&D decision making earlier, ensuring that trial designs match real-world usage, indication sequences match opportunity, and endpoints enable market access."

Analysts Offer Mixed Views

Four analysts have covered BioMarin since its May 5, 2026, release, all with varying ratings.

On May 5, Yun Zhong of Wedbush gave the company an 'Outperform' rating, with a 12-month price target of US$94.00, nearly doubling its current price. Zhong wrote, "We believe that launch of Yuviwel in early 2Q26 by Ascendis Pharma (ASND, OP) will have an impact on Voxzogo, but the magnitude remains to be seen."

H.C. Wainwright & Co.'s Mitchell Kapoor offered the company a 'Neutral' rating on the same day, with a price target of only US$55.00. Kapoor's reasoning: "Consensus moves from US$216M in 1Q26 to US$296M in 4Q26, which fits management’s 2H/4Q weighting and VOXZOGO’s ex-U.S. order dynamics. Large tenders, country-access timing, and periodic government orders can create material Q/Q lumpiness. The harder number is US$346M in 4Q27, vs. our US$239M estimate. By then, YUVIWEL should have built U.S. access, the expected European decision could pressure VOXZOGO’s largest revenue base, and oral FGFR rivals should be closer. Europe matters because ~75% of VOXZOGO revenue is ex-U.S.; a U.S.-only hit affects a minority of sales, while ex-U.S. markets drive most of the revenue base, and much of the 4Q order-timing strength consensus is extrapolating."

Ilya Zubkov and Boris Tolkachev of Freedom Broker also weighed in on May 5, giving BioMarin a 'Buy' rating, with a price target of US$105.00. They wrote: "Our Buy rating and $105 price target for BMRN are based on a weighted valuation approach, combining a 5-year DCF model employing the Free Cash Flow to the Firm (FCFF) method, and relative valuation multiples." The pair cited potential risks such as pipeline setbacks, development delays, potential competitive pressure, or possible softening demand across the enzyme therapy portfolio.

Lastly, Leland Gershell, MD and Ph.D., and Jason Dorr, PharmD., of Oppenheimer gave their opinion on May 5. The pair gave the company an 'Outperform' rating, with a price target of US$95. Their reasoning for the outperform target was: "We see shares as trading on the base business alone and anticipate outperformance on accelerating profitability, sales growth from newly-acquired assets, potentially supportive pipeline readouts (BMN 333, BMN 401), and potential development candidate acquisition/in-licensing."

Trials and Drugs in the Pipeline

According to the press release, the company plans to share topline results from its registration-enabling Phase 3 pivotal clinical trial of VOXZOGO in children with hypochondroplasia (CANOPY-HCH-3) in the first half of 2026. If the clinical results are positive, the company plans to submit data to health authorities in the second half of 2026 to seek approval for this new indication. [OWNERSHIP_CHART-4194]

BioMarin listed its 2026 full-year financial guidance as follows:

Updated guidance reflects post-close contributions from Amicus beginning April 27, 2026.
As previously communicated, the acquisition of Amicus is expected to be slightly dilutive to full-year 2026 Non-GAAP Diluted EPS; historical BioMarin Non-GAAP Diluted EPS guidance is unchanged.
The Amicus acquisition will be accounted for as a business combination, which will result in intangible amortization impacting GAAP results over future periods and excluded from Non-GAAP results. BioMarin will continue to include interest expense related to the Amicus financing in both GAAP and Non-GAAP financial results. Guidance is subject to change based on various factors, including finalization of purchase accounting.
The company expects approximately two-thirds of 2026 Non-GAAP Diluted EPS to be recognized in the second half of 2026, primarily due to the anticipated timing of revenue (more than 55% of 2026 Total Revenues is expected in 2H). Non-GAAP Diluted EPS in Q2 is expected to be modestly higher than in Q1.

With the acquisition of new drugs, companies, and advancing pipelines, the company expects a 20% growth rate in 2026.

Ownership & Share Information¹

BioMarin Pharmaceutical Inc. has a market cap of CA$10.46 billion, with 193.28 million shares outstanding. The company's 52-week range is US$50.76-US$66.28.

Institutions own 97% of shares, while Management & Insiders own 3% of shares.

Important Disclosures:

Cori Fisher wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee.
This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

1. Ownership and Share Structure Information

The information listed above was updated on the date this article was published and was compiled from information from the company and various other data providers.

( Companies Mentioned: BMRN:NASDAQ, )

Sublingual Drug Reformulator Expands into Caffeine Market and Gets Capital Injection

Fri, 08 May 2026 00:00:00 PST

Source: Stewart Thomson 05/08/2026

Technical Analyst Stewart Thomson reviews Aspire Biopharma Holdings, Inc. (ASBP:NASDAQ) in light of its recent news.

Aspire Biopharma Holdings, Inc. (ASBP:NASDAQ) is a biopharma company with a patent-pending drug delivery platform designed to enable rapid sublingual absorption that delivers drugs directly into the bloodstream through buccal tissues rather than through the digestive tract, thus bypassing first-pass metabolism in the liver.

To assist in the company's projected expansion, on May 7, Aspire announced that it will effect a reverse stock split of its common stock effective May 11, 2026, to reduce the number of shares of Common Stock issued and outstanding from approximately 36,329,490 to approximately 1,210,983.

A Platform-Driven Approach to Drug Delivery

Some Potential Advantages:

Convenience and Ease of Use: Dissolves easily under the tongue; useful for those who cannot swallow pills
Dose Management: Drugs avoid first-pass metabolism in the liver, potentially increasing the amount of active compound in the bloodstream

Sublingual Aspirin as a Proof of Concept

Aspire's most advanced pharmaceutical program is a high-dose sublingual aspirin formulation positioned for use in acute settings such as a suspected heart attack or stroke.

The market opportunity for sublingual aspirin is significant, with the combined opioid and non-opioid markets currently estimated at approximately US$80 billion, expected to grow to US$100 billion over the next five years.

A Pipeline Of Reformulated Drugs

Beyond aspirin, Aspire is positioning its platform across multiple therapeutic categories, including:

Alprazolam (generic Xanax®) – market value of ~US$3.6 billion
Clopidogrel (generic Plavix®) – market value of ~US$9.5 billion
Ondansetron (generic Zofran®) – market value of ~US$1.7 billion
Meclizine (generic Dramamine Less Drowsy®) – market value of ~US$1.8 billion

Rather than relying on the success of a single novel drug, Aspire is attempting to build a system that can be applied across multiple existing therapies.

Biopharma: Technical Observations & Analysis

Figure 1: SBIO-AMEX Medical Breakthroughs ETF (Price & Stochastics Oscillator Analysis)

The medical breakthroughs ETF is rising from a multi-year consolidation.

Stochastics (14,7,7 series) is on a buy signal.

Technically-oriented money managers are likely looking for new candidates to invest capital into as the breakout develops into an uptrend.

Aspire Biopharma Clinical Pipeline

Sublingual Aspirin: Aspire's lead candidate, a fast-acting high-dose sublingual aspirin for acute heart attacks, showed it could inhibit platelet aggregation in under two minutes-4 to 5 times faster than chewed tablets.
FDA Milestones: The company plans to file a New Drug Application (NDA) via the 505(b)(2) pathway near the end of 2026 for its lead aspirin candidate.
Expanded Pipeline: Formulation and development underway for generic sublingual versions of anti-anxiety drug (generic Xanax^®), anti-nausea drug (generic Zofran^®), anti-platelet drug (generic Plavix^®), as well as others
Intellectual Property: The company now has patents filed and pending on eleven different drugs and supplements, including the filing of an omnibus patent application with the U.S. Patent and Trademark Office for its sublingual delivery technology for several key drug classes.

An Expanding Retail Footprint: The Pre-Workout Market

This market is currently estimated at approximately US$20 billion and is expected to reach approximately US$28 billion by 2030.

On March 10, Aspire Biopharma announced that its subsidiary, Buzz Bomb Caffeine Company, is expanding its retail footprint with the launch of the BUZZ BOMB™ Convenience Store Pack.

Buzz Bomb Expansion

Product Launch: BUZZ BOMB™ launched its rebranded 50mg sublingual caffeine stick packs in the middle of January 2026.
Retail Partnerships:
o Partnered with TruLife Distribution for nationwide sales, distribution, and merchandising
o Signed agreements with Interwest Brokerage to expand retail footprint across the Intermountain West

Summary Of Corporate & Financial Milestones In 2026

Capital Injection: The company secured US$21 million in private placement financing in its February 2026 and April 2026 preferred stock offerings.
Exchange Compliance: Aspire regained compliance with Nasdaq's minimum stockholders' equity requirement in April 2026 and has received confirmation from Nasdaq.
Potentially Transformative Acquisition: On April 15, 2026, Aspire entered a Binding Letter of Intent to acquire DCS, a global automotive supplier, for approximately US$30 million in cash.
Commitment Letter: The company secured a Commitment Letter from a leading financial institution of up to US$22.5M to finance the proposed acquisition of DCS.

Key Risks

Regulatory, Clinical, and Technology Risk: Aspire's pharmaceutical candidates remain subject to FDA review and clinical testing.
Commercialization, Competition, and Partnership Risk: Even if approved, Aspire's products and BUZZ BOMB™ consumer offerings must compete against established pharmaceutical, energy, and supplement brands.
Financial, Market, and NASDAQ Risk: Aspire may require additional financing that could dilute shareholders.
Operational, Manufacturing, and Execution Risk: The company faces manufacturing, supply chain, intellectual property, and execution risks.

Shares Outstanding

5.02 million

Significant Shareholders

Technical Observations & Analysis For Aspire

Figure 2: Aspire Daily Bar Chart (Money Flow & Momentum Analysis)

The FORCE indicator (money flow) has rallied the most since November, in bullish divergence with the price.

The CCI (Commodity Channel Index) is a momentum indicator, and it is also showing bullish divergence with the price.

Figure 3: Aspire Daily Bar Chart (Price & Stochastics Oscillator Analysis)

Stochastics is oversold and has crossed into a buy signal.

There is bull wedge action with a potential breakout on the price chart.

This is occurring soon after the SBIO ETF breakout.

Stock price at time of writing (May 8, 2026): Approx. US$0.12

Short-Term Technical Price Target: US$0.25

Medium-Term Technical Price Target: US$3.00

Long-Term Technical Price Target: US$6.00

Technical Rating: Speculative Buy

Important Disclosures:

For this article, Aspire Biopharma Holdings Inc. has paid Street Smart, an affiliate of Streetwise Reports, US$4,000.
Author Certification and Compensation: Stewart Thomson was retained and compensated as an independent contractor by Street Smart for writing this article. Mr. Thomson is a retired Canadian financial advisor who has passed the Canadian Securities Course as well as additional technical analysis courses that were mandated by his former employer and approved by Ontario regulatory bodies. For the past 15 years, he has been editing and writing numerous financial newsletters that have a strong focus on charts. The recommendations and opinions expressed in this content reflect the personal, independent, and objective views of the author regarding any and all of the companies discussed. No part of the compensation received by the author was, is, or will be directly or indirectly tied to the specific recommendations or views expressed.
Statements and opinions expressed are the opinions of the author and not of Streetwise Reports, Street Smart, or their officers. The author is wholly responsible for the accuracy of the statements. Streetwise Reports requires contributing authors to disclose any shareholdings in, or economic relationships with, companies that they write about. Any disclosures from the author can be found below. Streetwise Reports relies upon the authors to accurately provide this information and Streetwise Reports has no means of verifying its accuracy.
This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services, or securities of any company.

For additional disclosures, please click here.

( Companies Mentioned: ASBP:NASDAQ, )

Biotech Innovator Niagen Uncovers Breakthrough NAD+ Booster, Reports Strong Q1 Results

Fri, 08 May 2026 00:00:00 PST

Source: Streetwise Reports 05/08/2026

Niagen Bioscience Inc. (NAGE:NASDAQ) reports a 3% increase in total net sales to US$31.5 million for the first quarter. Read why analysts recommend this stock in a rapidly expanding market.

Niagen Bioscience Inc. (NAGE:NASDAQ) released its financial results for the first quarter of 2026, reporting a 3% increase in total net sales to US$31.5 million, with US$22.4 million attributed to its Tru Niagen® product, according to a May 6 release.

When excluding the recently divested Analytical Reference Standards and Services segment, net sales saw a 5% rise to US$31.1 million, the company said. The gross margin stood strong at 63.5%, reflecting the ongoing robustness of the business mix. Net income for the quarter was US$6.3 million, which included a significant US$4.8 million gain from the sale of the Analytical Reference Standards and Services segment.

Earnings per share were reported at US$0.08 for basic and US$0.07 for diluted shares, the release stated. The company also noted an Adjusted EBITDA of US$3.8 million. Over the quarter, working capital increased by US$5.4 million, although US$1.2 million was used in operating cash flow, primarily due to higher inventory levels and the timing of receivables. The quarter ended with US$66.5 million in cash and cash equivalents. Additionally, Niagen Bioscience repurchased US$2.4 million of its common stock during this period.

"We delivered US$31.5 million of net sales and US$6.3 million of net income for the first quarter," Niagen Bioscience Chief Executive Officer Rob Fried said. “Our results reflect continued execution across the business, including growth in our e-commerce channel and progress across key strategic initiatives. We are advancing our scientific leadership and expanding our commercial reach while remaining focused on disciplined investment and long-term value creation from our NAD+ platform."

Co. Expanding Product, Service Offerings

Looking ahead to the full year of 2026, the company said it anticipates an increase in sales and marketing investments, with a revised outlook for general and administrative expenses expected to rise by US$3 million to US$4 million, improved from the previously forecasted US$4 million to US$5 million.

In recent operational developments, Niagen Bioscience has been actively expanding its product and service offerings. In May 2026, the company said it launched a clinician-directed telehealth platform called Niagen Plus, which allows eligible U.S. patients to access Niagen® at-home injection kits, broadening the reach of its clinic channel to include direct-to-patient access. April 2026 saw the establishment of the first United States Pharmacopeia (USP) monograph for nicotinamide riboside chloride (NRCL), a move that underscores the company's commitment to high standards in NAD+ science.

Additionally, the company has diversified its 503B network by adding a new compounding partner, expanding the Niagen Plus offerings. March 2026 was particularly eventful, with the launch of Niagen IV in over 80 Medi-Spa clinics on luxury cruise ships, the approval of a US$20 million increase in the company's share repurchase program, and the entry into the skincare market with the launch of Niagen's Nanocloud™. This skincare product, developed by the Niagen Skincare Innovation Lab, aims to assess market opportunities and gather consumer insights for future developments.

Furthermore, in February 2026, Niagen Bioscience completed the sale of its Analytical Reference Standards and Services segment to LGC Standards in an all-cash deal, streamlining its operations and reinforcing its focus on core scientific and commercial growth, the company said.

Niagen said it anticipates net sales to increase by 10-15% year-over-year in 2026, excluding sales from the divested Analytical Reference Standards and Services segment. This growth is expected to be driven mainly by the e-commerce business and new strategic partnerships. The company also projects a slight improvement in gross margin due to better inventory cost and product mix. Sales and marketing expenses are expected to rise both in absolute terms and as a percentage of sales, driven by increased investments to enhance customer acquisition and support new vertical launches. Research and development expenses are set to increase, focusing on pharmaceutical development and ongoing research into topical and injection applications.

Analyst: Results Exceed Estimates

Niagen's financial performance in the first quarter of 2026 surpassed cautious estimates across all major metrics, buoyed by robust e-commerce sales which compensated for diminished retail customer sales, reported an updated research note by Roth Capital Partners Analyst Sean McGowan on May 7.

The company also made notable strides in developing new revenue streams. It is anticipated that Niagen will escalate its spending in anticipation of revenue growth, with significant sales increases expected in the latter half of the year. Consequently, sales and EBITDA projections have been adjusted downward, and the price target has been reduced from US$13 to US$12. The rating was a Buy.

During the first quarter, NAGE encountered sales challenges due to the divestiture of a business segment and the decision by two major retail customers to halt orders amid their inventory adjustments, the analyst noted. Despite these challenges, sales, excluding the divested segment, grew by 5%. These challenges are expected to persist into the second quarter but should diminish as the year progresses. E-commerce sales of TruNiagen continued to show strong growth, particularly from NAGE's own website, which outpaced other sales channels.

Amidst these developments, the company enhanced its operational capabilities by adding a second compounding pharmacy to meet the robust demand for Niagen IV. Additionally, NAGE recently commenced the distribution of Nano Cloud, a promising niagen-based skin treatment product. Reflecting these operational adjustments and the lower sales to retail customers, the sales forecast for 2026 has been modestly reduced from US$148.3 million to US$142.1 million. Sales and marketing expenses have also been revised upward to support these initiatives.

In terms of product performance, TruNiagen grew by 4%, while ingredient sales increased by 5%, with Niagen ingredients specifically up by 2% year-over-year, McGowan noted. The introduction of the second compounding pharmacy is expected to enhance the availability of Niagen IV, potentially reducing retail costs and expanding the market reach. The company has also initiated a telehealth operation to facilitate access to at-home injectable products.

"Gross Margin rose to 63.5% up from 63.4% and compared to our estimate of 63.3%," the analyst said. "The upside was driven by shifts in the revenue mix. We expect gross margins in the for the year to approximately 64.4%, slightly above our prior estimate of 64.3%, which was also the full year level for 2025. 4Q to decline, as cost of sales in the Consumer segment will normalize. Our gross margin estimates for '27 and '28 are unchanged."

Lawsuit Against the FDA

Niagen Bioscience has recently initiated legal action against the FDA, its commissioner Martin Makary, the Department of Health and Human Services, and Health Secretary Robert F. Kennedy, challenging the FDA's decision to permit the sale of nicotinamide mononucleotide (NMN) products in the U.S., according to a research note by H.C. Wainwright & Co. Analyst Raghuram Selvaraju on March 5.

This lawsuit is grounded in the contention that the FDA's decision contravenes the 1938 Food, Drug and Cosmetic Act (FDCA), which originally banned the sale of such products because they were under investigation as a drug. The lawsuit argues that the FDA's decision, which appears to favor companies marketing NMN-based products illegally, was arbitrary and violated the Administrative Procedure Act.

While NMN-based products are not seen as a significant competitive threat to Niagen Bioscience's Tru Niagen, the potential regulatory removal of these products from the U.S. market, possibly by 2027, could facilitate a quicker sales acceleration for Niagen Bioscience, the note said. It is noteworthy that most NMN products available in the U.S. are manufactured in China, raising concerns about potential contamination risks.

The lawsuit is expected to be resolved through summary judgment, requiring a decision by a judge, which could potentially be delivered before the end of this year. Additionally, this legal battle is not anticipated to significantly impact the company's general and administrative (G&A) spending.

"We apply a 7.15x revenue multiple to our 12-month top-line estimate of US$144 million (discounted back at a 10% rate, which translates to ~US$119 million), which yields a price objective of US$12 per share," the analyst wrote. "Risks include, but are not limited to: (1) slower than projected U.S. sales growth; (2) unfavorable clinical data; (3) adverse legal decisions; (4) inability to achieve traction in ex-U.S. markets; and (5) disruptions due to geopolitical risk factors, including international tariffs (we note that supplements and nutraceuticals are currently tariff-exempt)."

Selvaraju rated the stock a Buy.

The Catalyst: Tech Advances Driving Explosive Growth

The global biotechnology market is experiencing rapid growth, with its valuation estimated at US$1.55 trillion in 2023 and projected to reach US$3.88 trillion by 2030, according to Grand View Research. This represents a robust compound annual growth rate (CAGR) of 13.96% from 2024 to 2030.

The expansion is significantly driven by the advancements in big data, artificial intelligence (AI), and machine learning (ML) technologies, which are increasing the demand for scalable and high-performance cloud infrastructure, the report said.

"The growing foothold of personalized medicine and an increasing number of orphan drug formulations are opening new avenues for biotechnology applications and are driving the influx of emerging and innovative biotechnology companies, further boosting the market revenue," Grand View said.

According to another report by Grand View, "The global anti-aging products market size was estimated at US$55.66 billion in 2025 and is projected to reach US$107.61 billion by 2033, growing at a CAGR of 8.9% from 2026 to 2033. The growth is increasingly anchored in a preventive approach to skincare rather than reactive treatment."

"Consumers across age groups are shifting focus toward early intervention, prioritizing daily routines that slow visible signs of aging before they become pronounced," that report noted. "This mindset has expanded demand across the industry, particularly for products positioned around long-term skin health, barrier repair, and collagen preservation."

According to a report by Abhay Rajput for Futurism on May 5, the increasing research and development in personalized medicine, numerous advancements in genetic engineering, and escalating demand for sustainable agriculture are some of the major factors propelling the market.[OWNERSHIP_CHART-11603]

Another major development is using AI to discover novel drugs, he wrote.

"AI and machine learning platforms are revolutionizing early-stage drug discovery by analyzing vast genomic and proteomic datasets to identify viable biological targets in a fraction of the time traditional methods require," he noted.

Ownership and Share Structure¹

About 2% of the company is owned by insiders and management, including the CEO Fried with 2.09%. About 27% is owned by strategic corporate entities, and about 45% by institutions. The rest is retail.

Other top shareholders include Brilliant Dynasty Ltd. with 14.32%, Pioneer Step Holdings Ltd. with 8.69%, BlackRock Institutional Trust Co. with 4.43%, and SteelPeak Wealth LLC with 4.24%.

Its market cap is US$333.71 million with 79.64 million shares outstanding. It trades in a 52-week range of US$4.04 and US$14.69.

Important Disclosures:

Steve Sobek wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee.
This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

1. Ownership and Share Structure Information

The information listed above was updated on the date this article was published and was compiled from information from the company and various other data providers.

( Companies Mentioned: NAGE:NASDAQ, )

Oncology Company Given Neutral Rating as Q1/26 Beat Sets Up Catalyst

Thu, 07 May 2026 00:00:00 PST

Source: Dr. David Nierengarten 05/07/2026

Wedbush Securities reiterated a Neutral rating on Novocure Ltd. (NVCR:NASDAQ) after the company posted a Q1/26 revenue beat of US$174.1 million, raised FY26 guidance to US$690710 million, and reported encouraging early Optune Pax launch metrics.

On April 30, 2026, analysts David Nierengarten, Dennis Pak, and Martin Fan of Wedbush Securities reiterated a Neutral rating and a 12-month price target of US$18.00 on Novocure Ltd. (NVCR:NASDAQ), implying upside of roughly 26.6% from the April 30, 2026 closing price of US$14.22, following a Q1/26 revenue beat and the company's first quarter of contribution from the newly approved Optune Pax device in pancreatic cancer.

Q1/26 revenue of US$174.1 million (-0.2% q/q, +12% y/y) topped Wedbush's US$170.7 million estimate, aided by approximately US$2.5 million of one-time benefits tied to higher approval rates in Germany and US$1 million tied to contract performance improvements in France. Excluding those items, organic revenue of approximately US$170.6 million was in line with the firm's estimate. Total active patients reached 4,791 globally, with 4,543 on Optune Gio (+9% y/y), 165 on Optune Lua (+56% y/y), and 83 on Optune Pax at quarter-end. Management raised FY26 revenue guidance to a range of US$690–710 million from US$675–705 million, while keeping the combined Optune Lua and Optune Pax contribution range at US$15–25 million.

The core glioblastoma (GBM) franchise continued to show steady international momentum, with Japan, Germany, and France contributing 20%, 12%, and 9% y/y active patient growth, respectively. U.S. active patients grew 4% y/y to 2,250, and management expects low-to-mid single-digit active patient growth in mature markets, with higher growth anticipated in newer geographies such as Spain and Czechia. Gross margin expanded to 78% from 75% in Q1/25, driven by lower array costs from improved utilization and supplier pricing, although management continues to guide to mid-70s gross margin for the full year as Optune Pax patients ramp ahead of broader reimbursement.

Early launch metrics for Optune Pax look encouraging, with 169 prescriptions received and 83 active patients on therapy in the seven weeks following FDA approval. The analysts noted they "would like to see a few additional quarters of momentum before getting more constructive on the opportunity" and expect reimbursement dynamics to limit near-term revenue contribution. They continue to view the lung opportunity as constrained by competition from targeted therapies and IO/chemo regimens, as well as limited median treatment duration in a relatively sick population.

Looking ahead, TRIDENT topline data remain the most meaningful near-term catalyst, with results expected in Q2/26. Positive data could extend the duration of therapy in the core GBM franchise by moving TTFields initiation earlier into the chemoradiation phase, though even with success, adoption will take time to translate into meaningful revenue. Beyond TRIDENT, the PMA decision in brain metastases from non-small cell lung cancer (NSCLC) is expected in Q4/26, alongside completion of enrollment in the Phase 3 KEYNOTE-D58 trial evaluating TTFields plus pembrolizumab in newly diagnosed GBM. The analysts continue to view brain metastases as a narrow commercial opportunity given limited treatment duration and poor prognosis.

The US$18.00 price target reflects a sum-of-parts valuation based on a 3× multiple to worldwide 2026E Optune sales in GBM, an 8× multiple to 2026E Zai Lab royalties, and a pipeline valuation that includes an 8× multiple to TTFields sales in metastatic brain cancer from NSCLC (40% discount), an 8× multiple to TTFields sales in 1L and 2L NSCLC (15–35% discount), and an 8× multiple to TTFields sales in 1L locally advanced pancreatic cancer (15% discount). Upside risks include better-than-expected Optune sales, broader clinical de-risking of TTFields, and potential M&A premiums, while downside risks include weaker-than-expected Optune sales/adoption and clinical failure of TTFields across multiple indications.

Company information at the time of the report included a market capitalization of US$1,382 million, an enterprise value of US$1,281 million, 108.2 million shares outstanding, a 52-week range of US$9.82–20.06, cash per share of US$3.98, tangible book value per share of US$3.03, and net debt of US $(252.63) million. Wedbush forecasts FY26 total revenue of US$707.3 million (raised from US$695.3 million prior) and FY27 revenue of US$765.3 million (raised from US$728.7 million), with EPS estimates of US$ (1.42) for FY26 and US$(0.86) for FY27.

Important Disclosures:

This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

Disclosures for Wedbush Securities, Novocure, April 30, 2026

Valuation 3x/8x mult. of our 2026E sales/royalty est. (discounted back 11%) + 8x mult. of 2027E brain met sales (discounted back 40%). Company Description NovoCure is an emerging player in the oncology market with its flagship product, Optune, which is approved in multiple countries for the treatment of newly-diagnosed and recurrent glioblastoma (GBM) and malignant pleural mesothelioma (MPM) Risks to the Attainment of Our Price Target and Rating: Upside risk to our current PT and rating include better-than-expected Optune sales and TTFields being broadly de-risked clinically and/or potential premiums associated around M&A activity. Further downside risk to our PT and rating include poorer-than-expected Optune sales/adoption and clinical failure of TTFields in multiple indications. Analyst Certification We, David Nierengarten, Dennis Pak and Martin Fan, , certify that the views expressed in this report accurately reflect our personal opinions and that we have not and will not, directly or indirectly, receive compensation or other payments in connection with our specific recommendations or views contained in this report. Mentioned Companies Investment Rating System: OUTPERFORM: Expect the total return of the stock to outperform relative to the median total return of the analyst's (or the analyst's team) coverage universe over the next 6-12 months. NEUTRAL: Expect the total return of the stock to perform in-line with the median total return of the analyst's (or the analyst's team) coverage universe over the next 6-12 months. UNDERPERFORM: Expect the total return of the stock to underperform relative to the median total return of the analyst's (or the analyst's team) coverage universe of the next 6-12 months. The Investment Ratings are based on the expected performance of a stock (based on anticipated total return to price target) relative to the other stocks in the analyst's coverage universe (or the analyst's team coverage).* Rating distribution (as of April 30, 2026) Investment Banking Relationships (as of April 30, 2026) OUTPERFORM: 74.68% OUTPERFORM: 12.43% NEUTRAL: 22.36% NEUTRAL: 7.55% UNDERPERFORM: 2.95% UNDERPERFORM: 0.00% The Distribution of Ratings is required by FINRA rules; however, WS' stock ratings of Outperform, Neutral, and Underperform most closely conform to Buy, Hold, and Sell, respectively. Please note, however, the definitions are not the same as WS' stock ratings are on a relative basis. The analysts responsible for preparing research reports do not receive compensation based on specific investment banking activity. The analysts receive compensation that is based upon various factors including WS' total revenues, a portion of which are generated by WS' investment banking activities. Company Specific Disclosures This information is subject to change at any time. This research is provided for educational and informational purposes only and is not intended to be relied upon as a forecast, research, or investment advice, and is not a recommendation, offer, or solicitation to buy or sell any securities or to adopt any investment strategy. Investing involves risk, including the risk of loss of principal. Your investments may decline in value due to both real and perceived general market, economic, and industry conditions. Diversification does not ensure profits or protect against loss. This research was prepared without regard to specific investment objectives, strategies, tax status, investment horizon, financial situation or needs of any investor. Wedbush Securities, Inc. (“WSI”) encourages recipients of this report to read all relevant offering documents (e.g., prospectus) pertaining to any investment concerned, including without limitation, information relevant to its www.wedbush.com Page 4 This report is intended for lifesciencesresearch@streetwisereports.com. Unauthorized distribution prohibited. investment objectives, risks, and costs before making an investment decision and when deemed necessary, to seek the advice of a legal, tax, and/or accounting professional. Past performance is no guarantee of future results. Reliance upon information in this research is at the sole discretion of the reader. All information in this research is believed to be reliable as of the date on which this research was issued and has been obtained from public sources believed to be reliable. No representation or warranty, either express or implied, is provided in relation to the accuracy or completeness of the information contained herein. The opinions expressed are as of the date written and are subject to change without notice. In addition, this research may contain certain statements deemed to be “forward-looking” statements. All statements, other than historical facts, contained within this document that address activities, events or developments that this research report expects, believes, or anticipates will or may occur in the future are forward-looking statements. These statements are based on certain assumptions and analyses made by WSI in light of its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate in the circumstances. Such statements are subject to assumptions, risks, uncertainties, many of which are beyond WSI’s control. Please note that any such statements are not guarantees of any future performance and that actual results or developments may differ materially from those projected in the forward-looking statements. Prepared by Wedbush Securities, Inc., a member of FINRA and SIPC. 1. WS makes a market in the securities of NovoCure. Price Charts NovoCure Rating History as of 04-29-2026 powered by: BlueMatrix 100 80 60 40 20 0 Jul 23 Oct 23 Jan 24 Apr 24 Jul 24 Oct 24 Jan 25 Apr 25 Jul 25 Oct 25 Jan 26 Apr 26 UP:$53.00 05/04/2023 N:$46.00 06/06/2023 N:$23.00 08/28/2023 N:$21.00 10/26/2023 N:$24.00 06/03/2024 N:$29.00 12/02/2024 N:$27.00 04/16/2025 N:$18.00 07/24/2025 Closing Price Price Target Outperform (OP); Neutral (N); Underperform (UP); Not Rated (NR) Wedbush disclosure price charts are updated within the first fifteen days of each new calendar quarter per FINRA regulations. Price charts for companies initiated upon in the current quarter, and rating and target price changes occurring in the current quarter, will not be displayed until the following quarter. Additional information on recommended securities is available on request. Disclosure information regarding historical ratings and price targets is available: Research Disclosures *WS changed its rating system from (Strong Buy/ Buy/ Hold/ Sell) to (Outperform/ Neutral/ Underperform) on July 14, 2009. Applicable disclosure information is also available upon request by contacting the Research Department at (212) 833-1375, by email to leslie.lippai@wedbush.com. You may also submit a written request to the following: Wedbush Securities, Attn: Research Department, 142 W 57th Street, New York, NY 10019. OTHER DISCLOSURES The information herein is based on sources that we consider reliable, but its accuracy is not guaranteed. The information contained herein is not a representation by this corporation, nor is any recommendation made herein based on any privileged information. This information is not intended to be nor should it be relied upon as a complete record or analysis: neither is it an offer nor a solicitation of an offer to sell or buy any security mentioned herein. This firm, Wedbush Securities, its officers, employees, and members of their www.wedbush.com Page 5 This report is intended for lifesciencesresearch@streetwisereports.com. Unauthorized distribution prohibited. families, or any one or more of them, and its discretionary and advisory accounts, may have a position in any security discussed herein or in related securities and may make, from time to time, purchases or sales thereof in the open market or otherwise. The information and expressions of opinion contained herein are subject to change without further notice. The herein mentioned securities may be sold to or bought from customers on a principal basis by this firm. Additional information with respect to the information contained herein may be obtained upon request. Wedbush Securities does and seeks to do business with companies covered in its research reports. Thus, investors should be aware that the firm may have a conflict of interest that could affect the objectivity of this report. Investors should consider this report as only a single factor in making their investment decision. Please see pages 3–7 of this report for analyst certification and important disclosure information. Retail Investors The information provided is for general informational purposes only and should not be considered an individual recommendation or personalized investment advice. The companies/investments mentioned may not be suitable for everyone. Each investor needs to review their own respective situation(s) before making any investment decisions. 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( Companies Mentioned: NVCR:NASDAQ, )

FDA Rejects Melanoma Drug Again as Analysts Slash Targets and Approval Path Comes Under Fire

Fri, 08 May 2026 00:00:00 PST

Source: Streetwise Reports 05/08/2026

Replimune Group Inc. (REPL:NASDAQ) received a second FDA rejection for RP1 in advanced melanoma, prompting analyst downgrades, price target cuts, and renewed debate over approval standards for cancer therapies.

Replimune Group Inc. (REPL:NASDAQ) announced that it received a complete response letter from the U.S. Food and Drug Administration for the company’s Biologics License Application for RP1 in combination with nivolumab for the treatment of advanced melanoma.

According to the company, the BLA was based on data from the IGNYTE trial involving patients with confirmed progression on an anti-PD-1-based regimen. Replimune stated that patients who received RP1 plus nivolumab demonstrated a 34% response rate with a median duration of 24.8 months and a favorable safety profile.

"It is deeply disappointing that the FDA has not exercised regulatory flexibility to meet patients' needs given the data supporting strong efficacy and the favorable safety profile," said Sushil Patel, Ph.D., CEO of Replimune, in a company news release. Patel added that "without timely accelerated approval, the development of RP1 will not be viable."

The company stated that the complete response letter followed a review process in which a different review team was appointed for the resubmission. According to the release, the new review team replaced the prior team that had interacted with the company during earlier stages of the application process.

Replimune said a senior member of the prior review team publicly stated that the "BLA clinical team thought the applicant had provided adequate evidence to support contribution of effect of RP1 plus nivolumab, but leadership did not agree."

The company also stated that the FDA appeared to contradict positions expressed during a September 2025 Type A meeting. Replimune said that after testimony from melanoma experts, the agency had not raised additional concerns regarding the heterogeneity of the patient population in the IGNYTE study and had acknowledged that randomizing patients to an anti-PD-1-only arm in the confirmatory study was not feasible.

According to the release, the company submitted a descriptive analysis proposal from IGNYTE-3 supporting the contribution of components and included data from IGNYTE showing median progression-free survival on RP1 plus nivolumab of 30.6 months compared to 4.4 months on the patients' prior PD-1-based regimen.

Replimune also stated that the FDA raised points related to tumor assessment methodology. The company said responses in IGNYTE were assessed using RECIST 1.1 without modifications and that analyses showed no material difference in response rates between injected and non-injected lesions. The company further stated that biopsies and surgical interventions did not impact tumor response.

Prior to the original BLA submission, Replimune stated that regulatory meetings were conducted to discuss trial design, patient population, and BLA package requirements. According to the release, FDA meeting minutes from March 2021 indicated that a single-arm trial could be acceptable for accelerated approval consideration if the data were sufficiently compelling. The company later submitted the BLA, which was accepted with a breakthrough therapy designation and granted priority review.

Replimune stated that melanoma is the fifth most common cancer, with approximately 112,000 new cases estimated in the United States in 2026 and nearly 8,500 deaths annually.

The company also referenced updated biomarker and clinical data presented at the 22nd European Association of Dermato-Oncology Congress in Prague, Czech Republic. According to the poster presentation, RP1 combined with nivolumab demonstrated an objective response rate of 33.6% and a median duration of response of 24.8 months in patients with advanced melanoma following anti-PD-1 treatment failure.

Advanced Melanoma Treatments Faced Ongoing Questions Around Approval Standards and Post-PD-1 Care

According to a May 2 report from Scientific American, approximately 110,000 new melanoma cases are diagnosed each year in the United States, while advanced disease remains significantly more difficult to treat once the cancer spreads beyond the original tumor site. The publication stated that "adding even one new option" for patients whose melanoma had not responded to first-line therapies "could make a big difference for patients' prognoses."

Scientific American wrote that some patients with advanced melanoma had "been left behind" after failing standard therapies. Yana Najjar, director of the Clinical and Translational Research Center at the University of Pittsburgh Medical Center Hillman Cancer Center, stated, "There's really no second-line treatments" for some patients. She added, "This is where I had hoped RP1 would come in."

The report described RP1 as an "oncolytic immunotherapy drug" created from "a modified version of a herpesvirus" designed to be injected directly into melanoma tumors. According to Scientific American, the treatment approach aimed to trigger the body's immune system to attack cancer cells "without damaging healthy tissue."

Scientific American also reported that the FDA had previously granted RP1 "breakthrough therapy" designation after early clinical trial results. The publication stated that a phase 1/2 clinical trial showed that "nearly 33 percent of patients with treatment-resistant advanced melanoma saw their condition improve with a combination of RP1 and a widely used immunotherapy drug called nivolumab." The article contrasted that outcome with "the 6 to 7 percent of similar patients who responded to nivolumab alone."

The publication reported that FDA review concerns centered on "the study population was too heterogeneous" and uncertainty regarding whether positive results were linked to RP1 rather than nivolumab. Scientific American noted that researchers and clinicians argued that the patient population "will be, by necessity, heterogeneous."

Michael Postow, chief of the melanoma service at Memorial Sloan Kettering Cancer Center, stated, "This is a space where patients need new advances the most.... It's always nice to have another option for them." Postow later added, "I really just want to make sure we all know what to do next here because we need some guidance."

Scientific American also discussed broader regulatory changes at the FDA, reporting that agency leadership announced a shift toward requiring one "pivotal" trial rather than two phase 3 studies for some approvals. The publication stated that randomized controlled trials in advanced cancer settings could be difficult because patients in control groups "would have to continue to use medications that previously had not worked for them."

In a separate May 6 sector report discussing melanoma development programs, Kaitlyn Bader wrote that unresectable or metastatic melanoma remained "one of the most clinically challenging presentations in dermatologic oncology." The article noted that before 2011, median overall survival for metastatic melanoma patients was "approximately six to nine months, with fewer than 10% surviving to five years."

According to the report, checkpoint inhibitors targeting CTLA-4, PD-1, and LAG-3 had "substantially altered the prognosis for a subset of patients," though "a meaningful proportion of patients experience primary or acquired resistance to checkpoint inhibition, limiting durable disease control."

The report stated that "patients who progress on PD-1-based therapy face a narrower range of subsequent options, making the development of mechanistically distinct approaches a continued clinical priority."

The article also discussed FDA Fast Track designation processes, stating that the designation was intended to "facilitate development and expedite FDA review of drugs targeting serious conditions with demonstrated potential to address unmet medical need." However, the report added that Fast Track status "should not be interpreted as evidence of clinical efficacy or safety."

A May 5 report from Stocktwits stated that the FDA rejected RP1 for a second time in April, citing "insufficient data to provide 'substantial evidence of effectiveness' in the treatment of unresectable advanced cutaneous melanoma."

According to the report, FDA Commissioner Marty Makary stated, "I don't work for Replimune, I work for the American people, and I stand by the scientists at the FDA." The report also quoted Makary as stating, "If your drug works, it's going to get approved."

The Stocktwits article reported that doctors writing in The Wall Street Journal criticized the FDA's decision and noted that the second FDA review team "did not say that the drug was ineffective, instead saying that it is 'unclear whether the drug was effective.'"

Analysts Cut Ratings and Targets Following FDA Setback

In an April 13 report, Robert Driscoll of Wedbush downgraded Replimune to "NEUTRAL (from OUTPERFORM)" and reduced its 12-month price target to US$2.00 from US$19.00.

Wedbush wrote that "the FDA issued a second complete response letter for REPL's BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab in PD-1 refractory melanoma." The report stated that the FDA identified "three deficiencies related to the IGYNTE study," including "an inability to isolate the contribution of RP1 when administered in combination with nivolumab, heterogeneity of the study population, and uncertainty of response assessments, including surgical interventions with potential for confounding response results."

According to the Wedbush report, the FDA also stated that the BLA resubmission included "exploratory analyses from IGNYTE and an early analysis of data from the ongoing confirmatory Ph 3 that it did not believe alleviated concerns previously communicated regarding the inconsistency of response criteria used in IGNYTE with RECIST v1.1."

Wedbush noted that Replimune's response "highlights inconsistencies with FDA regulatory process and communications." The report stated that Replimune indicated data from the Phase 3 study "showed a PFS of 30.6 months for RP1 plus nivo. compared to 4.4 months on prior PD-1-based regimen, indicating a significant treatment effect for the addition of RP1."

The report also stated that Replimune indicated "detailed analyses provided to the FDA showed no material difference in response rates between injected and non-injected lesions," and that "a comprehensive analysis showed that biopsies and surgical interventions did not impact tumor response."

Wedbush wrote, "Overall, we view the additional CRL as disappointing given what we viewed as convincing treatment effect in a patient population with significant unmet need." The firm added, "We see no path forward for RP1 with IGNYTE, and significant risk with regards to the ongoing Ph 3 study." Wedbush stated that it was "downgrading to NEUTRAL and reducing our PT to US$2 (from US$19)."

In a separate April 13 H.C. Wainwright research note, analyst Robert Burns downgraded Replimune to "Sell" from "Buy" and removed its price target.

H.C. Wainwright wrote, "RP1's path to market just became painfully longer, in our view—downgrading to Sell without a price target." The report stated that the FDA's second complete response letter cited "three principal areas: (1) inability to isolate the contribution of RP-1 when administered in combination with nivolumab; (2) heterogeneity of the patient population, preventing adequate interpretation of the results; and (3) lack of a well-established historical control, which limits comparisons of response rate."

According to the H.C. Wainwright report, "we believe that the ongoing Phase 3 IGNYTE-3 trial evaluating RP-1 + Opdivo vs. the physician's treatment choice will also inevitably encounter the same issues with the FDA."

The report further stated, "We see a significantly longer path for RP-1 to reach the market, if at all." H.C. Wainwright added, "The company is facing a significant crisis and may not be able to pivot successfully."

H.C. Wainwright stated that it was "downgrading our rating to Sell from Buy, while removing our price target," and added that it awaited "clarity on the regulatory path forward and the revised timeline to potential submission of the RP1 dossier with additional clinical data ahead of revising our assumptions."

IGNYTE Trial and Regulatory Developments

According to Replimune, the company initiated the global Phase 3 IGNYTE-3 trial following FDA feedback in order to satisfy the regulatory requirement that a confirmatory study be underway for accelerated approval.

The company stated that the IGNYTE trial enrolled 140 patients with anti-PD-1-failed cutaneous melanoma. The poster presentation reported that updated objective response rates showed "clinically meaningful benefits across biological subgroups. [OWNERSHIP_CHART-9741]

The presentation also reported a 26.2% objective response rate in patients previously treated with anti-PD-1 and anti-CTLA-4 therapy and a 34.8% response rate in patients with primary resistance to anti-PD-1 therapy.

According to the data, treatment with RP1 plus nivolumab resulted in increases in intratumoral PD-L1 expression and CD8+ T cells post-treatment. The presentation stated that PD-L1 expression increased in 56% of paired lesions, and CD8+ T cells increased in 37% of paired lesions.

The presentation further stated that RP1 plus nivolumab increased expression of the interferon-gamma signature and expanded existing T-cell clones while generating new T-cell clones associated with melanoma and HSV-1 responses.

As per the conclusions section of the presentation, the safety profile remained consistent with the primary analysis, with "generally transient grade 1/2 side effects."

Ownership & Share Structure¹

Replimune Group Inc. has a market cap of US$140.37 million, with 82.57 million shares outstanding. The company's 52-week range is US$1.50-US$13.24.

Institutions hold 97.32% of shares, and Management & Insiders own 2.68% of shares.

Important Disclosures:

James Guttman wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee.
This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

1. Ownership and Share Structure Information

The information listed above was updated on the date this article was published and was compiled from information from the company and various other data providers.

( Companies Mentioned: REPL:NASDAQ, )

Oncology Co. Tests Advanced Cancer Treatments, Reports Q1 2026 Financial Results

Wed, 06 May 2026 00:00:00 PST

Source: Streetwise Reports 05/06/2026

Novocure Ltd. (NVCR:NASDAQ) posted 12% revenue growth, strong international patient gains, FDA momentum, and promising pancreatic cancer trial results in 2026.

Novocure Ltd. (NVCR:NASDAQ) released its financial and operational results in Q1 2026 on April 30, 2026. Based in Switzerland, NovoCure is a global oncology company focused on extending survival and improving quality of life in someone the most aggressive cancers. Its proprietary therapy uses Tumor Treating Fields (TTFields), which are approved mainly for glioblastoma, pancreatic cancer, non-small cell lung cancer, malignant pleural mesothelioma, and pleural mesothelioma.

According to the press release, financial highlights for Q1 2026 are as follows:

Total net revenues for the quarter were US$174.1 million, an increase of 12% compared to the same period in 2025. This increase was primarily driven by active patient growth in European markets.

The U.S., Germany, France, and Japan contributed US$96.0 million, US$24.5 million, US$22.9 million, and US$10.2 million, respectively, with other active markets contributing US$15.7 million.

Net revenue from Germany benefited from increased approval rates, including a one-time benefit of US$2.5 million.
Net revenue from France benefited from contract performance improvements, including a one-time benefit of US$1 million.

Revenue in Greater China from Novocure's partnership with Zai Lab totaled US$4.8 million.
Recognized revenue from Optune Lua® in the quarter was US$3.1 million.

Gross margin for the quarter was 78% compared to 75% in the prior year. The increase was primarily driven by lower array costs resulting from improved array utilization and lower supplier prices.
Research, development, and clinical study expenses for the quarter were US$58.3 million, an increase of 8% from the same period in 2025. This was primarily driven by increased costs associated with patient recruitment in the Phase 3 KEYNOTE D58 clinical trial.
Sales and marketing expenses for the quarter were US$58.4 million, an increase of 5% compared to the same period in 2025. This was primarily driven by costs associated with the launch of Optune Pax® in the U.S. and Optune Lua® in Japan.
General and administrative expenses for the quarter were US$85.9 million, an increase of 92% compared to the same period in 2025. This increase was primarily driven by a US$43 million share-based compensation expense triggered by the U.S. FDA approval of Optune Pax®. This non-cash expense is reported in accordance with U.S. GAAP, but the associated grant did not vest, and shares were not distributed.
Net loss for the quarter was US$71.1 million with a loss per share of US$0.62.
Adjusted EBITDA for the quarter was US$(0.3) million.
Cash, cash equivalents, and short-term investments were US$432.0 million as of March 31, 2026.

Operational highlights were as follows:

As of March 31, 2026, there were 4,791 total active patients on TTFields therapy globally.
Optune Gio®

As of March 31, 2026, there were 4,543 active patients on Optune Gio, an increase of 9% from the same period in 2025.
The U.S., Germany, France, and Japan contributed 2,250, 641, 503, and 535 Optune Gio® active patients, respectively, with 614 active patients contributed by other active markets.

Optune Lua®

As of March 31, 2026, there were 165 active patients on Optune Lua®, an increase of 56% from the same period in 2025.
The U.S., Germany, France, and Japan contributed 106, 47, 2, and 6 active patients, respectively, with 4 active patients contributed by other active markets.

Optune Pax®

169 prescriptions for Optune Pax® were received in the quarter.
As of March 31, 2026, there were 83 active patients on Optune Pax® in the U.S.

The company also provided Q1 2026 achievements, such as Czechia agreeing to cover Optune Gio®, the FDA approving Optune Pax® for treatment of adult patients who meet certain criteria, and British Columbia Cancer choosing to cover Optune Gio® for newly-diagnosed patients.

Japan also adopted Optune Lua® in 2026, approving reimbursement for the drug via the country's national health insurance program. Finally, Novocure announced results from its latest Phase 2 clinical trial for PANOVA-4, evaluating ". . . TTFields therapy concomitant with atezolizumab (Tecentriq®), gemcitabine and nab-paclitaxel as a first-line treatment for metastatic pancreatic cancer. PANOVA-4 met its primary endpoint, achieving a 74% disease control rate (DCR), a statistically significant improvement compared to a 48% DCR in patients treated with gemcitabine and nab-paclitaxel alone in the historical control."

In the release, Frank Leonard, CEO of NovoCure, said, "This was a very strong start to the year for NovoCure, and we are pleased with the progress made across our commercial and clinical programs. We reached several key milestones in the first quarter and are eager to maintain this momentum as we approach numerous exciting catalysts later this year. Our focus remains on bringing Tumor Treating Fields therapy to patients diagnosed with some of the most aggressive forms of cancer, further exploring the use of our therapy to benefit patients in need, and achieving sustainable growth and profitability."

R&D Spending Down Despite Demand

The global cancer treatment sector, unfortunately, shows no signs of shrinking. A March 26, 2026, article by Kinjel Shah for Yahoo Finance claimed that cancer incidences were rising. He quoted the American Cancer Society as expecting 2.1 million new cancer cases and over 626,000 cancer-related deaths in 2026. However, technology is ever-evolving to keep up with the disease.

Shah wrote, "Emerging technologies such as genomic sequencing, artificial intelligence, and machine learning are accelerating biomarker discovery, enhancing patient stratification, and enabling earlier and more accurate diagnoses. While a universal cure remains out of reach, consistent improvements in survival rates and patient outcomes across multiple cancer types highlight the tangible benefits of these advances, particularly when combined with earlier detection and intervention."

This innovation comes at a price. In February 2026, Keith Speights wrote an article for The Motley Fool discussing rising care costs, stating that cancer treatments in the U.S. cost roughly US$200 billion in 2020 but are expected to increase to more than US$245 billion by 2030.

Many in the pharma sector have been cutting research and development (R&D) costs since the pandemic, citing lower returns. "R&D work on complex, expensive therapies could taper off as companies prioritize already or nearly commercialized drugs, and companies may further consolidate roles to maintain leaner operations," argued BDO at the beginning of 2026. But some companies, like NovoCure, are still investing heavily in drug development.

Expert Patient with Stock

On April 30, 2026, Kevin DeGeeter of Landenburg Thalmann gave the company a 'Buy' rating, with a US$27.00 price target. DeGetter said, ". . . if NVCR can follow up from the Elevance Health coverage decision with additional positive coverage determinations from commercial payors in the next six months, in our view, top end of guidance for revenue of US$25 million from new products may be conservative. We are raising our 2026 revenue estimate from US$697.6 million to US$701.0 million. Our estimate of revenue from new products is US$22.0 million."

Also on April 30, 2026, Emily Bodnar of H.C. Wainwright & Co. gave the company a 'Buy' rating, with a price target of US$48.00, noting the company's wide breadth of prescribers as an important catalyst.

In a third April 30, 2026, report, David Nierengarten, Ph.D., of Wedbush gave the company a 'Neutral' rating, with a price target of US$18.00. Niernegarten wrote that the company's target disease could represent a limited opportunity, saying, "We continue to view brain metastases as a narrow commercial opportunity given limited treatment duration and poor prognosis in this population."

In response to NovoCure's financial results, Chen Lin of What is Chen Buying? What is Chen Selling? weighed in on May 4, 2026: "I was asked about my NVCR target. I hope it can reach sales of US$1 billion+ in a couple of years (currently US700 million). Over US$1 billion in sales with no patent threats should be worth at least US$5-10 billion, which is about 40-80, maybe 100 if I am lucky. But it will take some time, you know. However, I like the fact that they are fully funded to profitability." [OWNERSHIP_CHART-10142]

Two More Trials Planned

As of April 30, 2026, NovoCure has updated its 2026 financial guidance as follows:

Total net revenue: US$690 million-US$710 million (previous: US$675 million-US$705 million)
Adjusted EBITDA: US$(15) million - US$0 million (previous: US$(20) million - US$0 million)

In Q2 2026, the company expects topline data from the Phase 3 TRIDENT trial for newly diagnosed glioblastoma patients. In Q4 2026, NovoCure anticipates a decision from the FDA on its premarket approval application for the use of TTFields therapy as a treatment for brain metastases. Finally, to round out the year, the company hopes to complete enrollment for its Phase 3 KEYNOTE D58 trial for newly diagnosed glioblastoma patients.

Ownership & Share Information¹

NovoCure Ltd. has a market cap of US$1.84 billion, with 115.82 million shares outstanding. The company's 52-week range is US$9.82-US$20.06.

Institutions own 80.91% of shares, while Management & Insiders own 9.97%. The remaining 9.13% of shares are Retail.

Important Disclosures:

Cori Fisher wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee.
This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

1. Ownership and Share Structure Information

The information listed above was updated on the date this article was published and was compiled from information from the company and various other data providers.

( Companies Mentioned: NVCR:NASDAQ, )

Biotech Co. Advances AI Detection Breakthrough for Intoxication Safety

Mon, 11 May 2026 00:00:00 PST

Source: Streetwise Reports 05/11/2026

MindBio Therapeutics Corp. (MBIO:CSE; MBQIF:OTCQB; WF6:Frankfurt) enhances AI speech analysis tech with cross-language capability, paving the way for major accident-prevention potential.

On May 5, 2026, MindBio Therapeutics Corp. (MBIO:CSE; MBQIF:OTCQB; WF6:Frankfurt) announced the upgrade of its proprietary AI intoxication technology to include cross-language speech compatibility with an agnostic language model. With operations set to deploy in South America, this compatibility is crucial.

MindBio Therapeutics is a Canadian biotech company leveraging AI technology to detect impairment from drugs or alcohol through voice analysis. The company is developing software that could help reduce intoxication-related accidents in both corporate and personal settings. Its proprietary technology analyzes over 140 vocal markers, sifting through parameters like spectral entropy, jitter, and shimmer, and speech rate variability.

CEO of MindBio, Justin Hanka, said, “The ability to detect neurologically active substances from speech analysis is a game changer for the scalable detection of intoxication for enhanced promotion of health and safety”.

A Sector in Need

Experts Say Tech Could Prevent Huge Losses

Developing a Boon for Critical Sectors

Currently, MindBio is creating inroads into the mining, aviation, construction, and law enforcement industries.

While enterprise and telehealth capacities are in development right now, future plans include disease prediction and health optimization.

Ownership & Share Information²

Important Disclosures:

MindBio Therapeutics Corp. is a billboard sponsor of Streetwise Reports and pays SWR a monthly sponsorship fee between US$3,000 and US$6,000.
As of the date of this article, officers, contractors, shareholders, and/or employees of Streetwise Reports LLC (including members of their household) own securities of MindBio Therapeutics Corp.
Cori Fisher wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee.
This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

1. Disclosure for the quote from the Stewart Thomson article published on April 1, 2026

For the quoted article (published on April 1, 2026), MindBio Therapeutics Corp. has paid Street Smart, an affiliate of Streetwise Reports, US$3,500.
Author Certification and Compensation: Stewart Thomson was retained and compensated as an independent contractor by Street Smart for writing this article. Mr. Thomson is a retired Canadian financial advisor who has passed the Canadian Securities Course as well as additional technical analysis courses that were mandated by his former employer and approved by Ontario regulatory bodies. For the past 15 years, he has been editing and writing numerous financial newsletters that have a strong focus on charts. The recommendations and opinions expressed in this content reflect the personal, independent, and objective views of the author regarding any and all of the companies discussed. No part of the compensation received by the author was, is, or will be directly or indirectly tied to the specific recommendations or views expressed.

For additional disclosures, please click here.

2. Ownership and Share Structure Information

The information listed above was updated on the date this article was published and was compiled from information from the company and various other data providers.

( Companies Mentioned: MBIO:CSE; MBQIF:OTCQB; WF6:Frankfurt, )

MA Biotech Downgraded to Neutral After Second FDA CRL for RP1 Melanoma BLA

Wed, 06 May 2026 00:00:00 PST

Source: Dr. Robert Driscoll 05/06/2026

Wedbush Securities downgraded Replimune Group Inc. (NASDAQ:REPL) to NEUTRAL after the FDA issued a second complete response letter for RP1 in PD-1 refractory melanoma.

On April 13, 2026, analysts Robert Driscoll, Ph.D., and Geoffrey Von Der Ahe of Wedbush Securities downgraded Replimune Group Inc. (REPL:NASDAQ) to NEUTRAL from OUTPERFORM and lowered their 12-month price target to US$2.00 from US$19.00, implying downside from the April 13, 2026, closing price of US$4.76, following the FDA's issuance of a second complete response letter (CRL) for the company's Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab in PD-1 refractory melanoma.

The FDA had previously issued a CRL in July 2025, citing a heterogeneous patient population and an inadequately controlled study, which did not allow substantial evidence of efficacy to be established from the single-arm Phase 2 IGNYTE trial that enrolled 140 patients. After a Type A meeting, Replimune submitted a complete response, leading to an April 10 PDUFA date. In the updated CRL, the FDA cited three deficiencies tied to the IGNYTE study: an inability to isolate RP1's contribution when administered with nivolumab, heterogeneity of the study population, and uncertainty around response assessments, including surgical interventions with the potential to confound results.

According to the analysts, the FDA also concluded that exploratory analyses from IGNYTE and an early look at data from the ongoing confirmatory Phase 3 trial (representing roughly 10% of the patient population) did not alleviate previously communicated concerns about inconsistencies between IGNYTE response criteria and RECIST v1.1. The agency pointed to evaluation shortcomings in the Phase 3 trial, including responses measured only by the investigator, a lack of durability data, and insufficient controls. Specific confounders cited included fewer than 50% noninjected target lesions, inclusion of re-injected patients following progression, surgical interventions and removal of target lesions, and potential bias from histological response. The FDA further referenced concerns raised in Type B meetings in March 2021 and September 2024 regarding the single-arm study design and approval potential. Topline data from the randomized CERPASS Phase 2 study in advanced cutaneous squamous cell carcinoma (CSCC), evaluating RP1 plus cemiplimab versus cemiplimab alone, were announced in December 2023 and did not meet its primary endpoint. The FDA invited Replimune to discuss a revised protocol and statistical analysis plan or propose a new clinical study, which the analysts view as signaling significant risk for continuing the Phase 3 in its current form.

Replimune's response, the analysts noted, highlighted inconsistencies with the FDA's regulatory process and communications. The company indicated that during a Type A meeting in September 2025, the FDA acknowledged that randomizing patients to an anti-PD-1-only arm in the confirmatory study was not feasible and had not raised heterogeneity concerns following melanoma expert testimony. Phase 3 data requested by the agency showed progression-free survival (PFS) of 30.6 months for RP1 plus nivolumab compared to 4.4 months on prior PD-1-based regimens, indicating a significant treatment effect. Replimune also stated that detailed analyses showed no material difference in response rates between injected and non-injected lesions, and that biopsies and surgical interventions did not impact tumor response. The company highlighted that a different review team was appointed for the resubmission, replacing a prior team, with a senior member of the prior team publicly stating on a subsequently deleted LinkedIn post that the "BLA clinical team thought the applicant had provided adequate evidence to support contribution of effect of RP1 plus nivolumab, but leadership did not agree."

The analysts characterized the additional CRL as disappointing given what they viewed as a convincing treatment effect in a patient population with significant unmet need. They referenced the FDA's own analysis showing that patients treated with single-agent anti-PD-1 after confirmed progressive disease on anti-PD-1 demonstrated a 6%–7% response rate (Beaver et al., 2018; Ribas et al., 2018). They also pointed to Iovance Biotherapeutics Inc.'s (IOVA:NASDAQ) TIL therapy Amtagvi, which was approved in February 2024 based on single-arm study data showing an objective response rate of 31.5% with a treatment-related mortality of 7.5%, as well as the prior approval of monotherapy T-vec as evidence of single-arm activity for an oncolytic virus with a similar backbone.

On valuation, the price target is based on 7x estimated US sales and 15x estimated EU royalties of RP1 in PD-1 refractory melanoma in 2029, discounted by 20%. Replimune is a clinical-stage biopharmaceutical company based in Woburn, Massachusetts, developing intratumorally delivered oncolytic virus therapies. As of April 13, 2026, the company had a market capitalization of US$393 million, 92.2 million shares outstanding, and a 52-week trading range of US$2.68 to US$13.24. The analysts model GAAP EPS of (US$3.54) for FY2025E, (US$2.42) for FY2026E, and (US$2.37) for FY2027E, with the revised price target reflecting expected cash in Q2 2027 and acknowledging that a likely restructuring ahead may alter estimates. Risks to the rating and price target include clinical and regulatory failure of RP1, inability to achieve sales estimates, potential safety signals halting development, and commercial challenges from current and future therapies. The analysts said they see no path forward for RP1 with IGNYTE and significant risk for the ongoing Phase 3 study, and they look forward to potential clarity around readthrough of the identified deficiencies to ongoing studies of RP2, including the randomized Phase 2/3 REVEAL trial in uveal melanoma.

Important Disclosures:

This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

Disclosures for WedBush Securities, Replimune Group, April 13, 2026

Valuation Our PT is based on 7x est. US sales and 15x est. EU royalties of RP1 in PD-1 refractory melanoma in 2029, discounted by 20%. Company Description Replimune is a clinical-stage biopharmaceutical company based in Woburn, MA, developing intratumorally-delivered oncolytic virus (OV) therapies. Risks to the Attainment of Our Price Target and Rating: Risks to the attainment of our price target and rating for REPL include clinical and regulatory failure of RP1 and an inability to achieve sales estimates. RP1 may not prove to be efficacious, or safety signals could halt development. RP1 could also face commercial challenges from current and future therapies Analyst Certification We, Robert Driscoll and Geoffrey Von Der Ahe, certify that the views expressed in this report accurately reflect our personal opinions and that we have not and will not, directly or indirectly, receive compensation or other payments in connection with our specific recommendations or views contained in this report. Mentioned Companies Investment Rating System: OUTPERFORM: Expect the total return of the stock to outperform relative to the median total return of the analyst's (or the analyst's team) coverage universe over the next 6-12 months. NEUTRAL: Expect the total return of the stock to perform in-line with the median total return of the analyst's (or the analyst's team) coverage universe over the next 6-12 months. UNDERPERFORM: Expect the total return of the stock to underperform relative to the median total return of the analyst's (or the analyst's team) coverage universe of the next 6-12 months. The Investment Ratings are based on the expected performance of a stock (based on anticipated total return to price target) relative to the other stocks in the analyst's coverage universe (or the analyst's team coverage).* Rating distribution (as of April 13, 2026) Investment Banking Relationships (as of April 13, 2026) OUTPERFORM: 74.89% OUTPERFORM: 12.50% NEUTRAL: 22.13% NEUTRAL: 5.77% UNDERPERFORM: 2.98% UNDERPERFORM: 0.00% The Distribution of Ratings is required by FINRA rules; however, WS' stock ratings of Outperform, Neutral, and Underperform most closely conform to Buy, Hold, and Sell, respectively. Please note, however, the definitions are not the same as WS' stock ratings are on a relative basis. 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This research was prepared without regard to specific investment objectives, strategies, tax status, investment horizon, financial situation or needs of any investor. Wedbush Securities, Inc. (“WSI”) encourages recipients of this report to read all relevant offering documents (e.g., prospectus) pertaining to any investment concerned, including without limitation, information relevant to its investment objectives, risks, and costs before making an investment decision and when deemed necessary, to seek the advice of a legal, tax, and/or accounting professional. Past performance is no guarantee of future results. Reliance upon information in this research is at the sole discretion of the reader. All information in this research is believed to be reliable as of the date on which this research was issued and has been obtained from public sources believed to be reliable. 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Please note that any such statements are not guarantees of any future performance and that actual results or developments may differ materially from those projected in the forward-looking statements. Prepared by Wedbush Securities, Inc., a member of FINRA and SIPC. 1. WS makes a market in the securities of Replimune. Price Charts Replimune Rating History as of 04-10-2026 powered by: BlueMatrix 60 50 40 30 20 10 0 Jul 23 Oct 23 Jan 24 Apr 24 Jul 24 Oct 24 Jan 25 Apr 25 Jul 25 Oct 25 Jan 26 Apr 26 OP:$14.00 12/05/2023 OP:$16.00 02/08/2024 OP:$19.00 02/12/2025 N:$4.00 07/22/2025 OP:$18.00 10/20/2025 OP:$19.00 02/03/2026 Closing Price Price Target Outperform (OP); Neutral (N); Underperform (UP); Not Rated (NR) Wedbush disclosure price charts are updated within the first fifteen days of each new calendar quarter per FINRA regulations. Price charts for companies initiated upon in the current quarter, and rating and target price changes occurring in the current quarter, will not be displayed until the following quarter. Additional information on recommended securities is available on request. Disclosure information regarding historical ratings and price targets is available: Research Disclosures *WS changed its rating system from (Strong Buy/ Buy/ Hold/ Sell) to (Outperform/ Neutral/ Underperform) on July 14, 2009. Applicable disclosure information is also available upon request by contacting the Research Department at (212) 833-1375, by email to leslie.lippai@wedbush.com. You may also submit a written request to the following: Wedbush Securities, Attn: Research Department, 142 W 57th Street, New York, NY 10019. OTHER DISCLOSURES The information herein is based on sources that we consider reliable, but its accuracy is not guaranteed. 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All expressions of opinion are subject to change without notice due to shifting market(s), economic or political conditions. Investment involves risks including the risk of principal. Past performance is no guarantee of future results and the opinions presented cannot be viewed as an indicator of future performance.

( Companies Mentioned: REPL:NASDAQ, )

CleanTech Company Advances Global PFAS Water Treatment Partnership with Aquatech

Fri, 08 May 2026 00:00:00 PST

Source: Streetwise Reports 05/08/2026

Cleantech and life sciences innovator BioLargo Inc. (BLGO:OTCQX) notches multiple wins this week for the distribution of its products worldwide.

BioLargo Equipment Solutions & Technologies Inc. (BEST), a subsidiary of environmental engineering leader BioLargo Inc. (BLGO:OTCQX), announced it has entered into a memorandum of understanding (MOU) to partner with water purification leader Aquatech on making water safer worldwide, according to a May 4 release.

The company's innovative Aqueous Electrostatic Concentrator (AEC) technology is designed to extract PFAS from water, paired with downstream treatment for full PFAS management with minimal waste generation.

The companies will work together to integrate and commercialize the AEC technology and incorporate it into Aquatech’s comprehensive PFAS treatment systems, which include destruction processes, the release noted. This collaboration bolsters both companies' capabilities to offer integrated solutions that meet the stringent regulatory demands for PFAS treatment in both public and private sectors.

Aquatech, celebrated for its commitment to technical excellence and innovation in water and wastewater management, was voted Water Technology Company of the Year at the 2025 Global Water Awards, presented during the Global Water Summit in Paris. Its portfolio spans a variety of cutting-edge technologies including membrane-based, thermal, biological, electrochemical, and ultrapure water treatment solutions, BioLargo noted.

"By partnering with Aquatech — one of the most respected and capable organizations in the global water treatment industry — we can significantly amplify the reach and impact of our Aqueous Electrostatic Concentrator technology," BEST President Tonya Chandler said. "Together, we are combining proven engineering, innovative science, and deep market experience to deliver scalable PFAS treatment solutions for industrial, municipal, and government clients."

The agreement outlines a non-exclusive collaboration framework, allowing both companies to leverage their complementary technologies to better address the burgeoning needs of the PFAS remediation market, BioLargo said.

"Coupling BioLargo's AEC PFAS collection and concentration technology with Aquatech's PFAS removal and destruction expertise presents a powerful opportunity to fast-track effective solutions to serve the customer," Aquatech Environmental Services Vice President Devesh Mittal said.

BioLargo said the MOU underscores its strategic approach to forge robust alliances with industry leaders to broaden market reach and expedite the adoption of its clean technologies.

Regulations Pushing Governments to Invest in Effective PFAS Removal

The PFAS filtration market is expected to experience significant growth, expanding from US$2.34 billion in 2026 to US$3.28 billion by 2031, achieving a compound annual growth rate (CAGR) of 7% over this period. This forecast, provided by Markets and Markets, attributes the growth primarily to rising awareness of the health and environmental hazards posed by PFAS chemicals. These substances, known for their persistence in the environment, have been associated with various serious health issues including cancer, hormone disruption, and immune system effects.

In response to these concerns, governments across North America, Europe, and parts of Asia are enacting more stringent regulations concerning PFAS levels in drinking water, industrial wastewater, and consumer products. These regulatory actions are driving municipalities and industries to seek out and invest in effective PFAS removal technologies.

Rice University Tina and Sunit Patel Professor in Molecular Nanotechnology Michael S. Wong's research focuses on capturing PFAS from water and breaking them down into harmless components, potentially revolutionizing the management of these persistent pollutants.

Wong explained in a recent Expert Alert Q&A posted by the university that that PFAS are notoriously difficult to destroy due to their chemical structure. These compounds are made up of carbon-fluorine bonds, one of the strongest in chemistry, which allows them to resist natural degradation processes. This resilience makes PFAS useful in various products like cookware and textiles but also means they can persist in the environment long after their use.

Wong pointed out that water is a critical starting point for addressing PFAS.

"Water is often the most practical intervention point because it serves as a primary transport pathway for contaminants," he said. "Treating water allows for controlled, centralized mitigation before PFAS spread further through ecosystems or drinking supplies. It is also where many existing treatment infrastructures already operate, making it a logical platform for new technologies."

Distribution for Clyra's ViaCLYR™ Expanding

On May 5, BioLargo announced a win for another subsidiary, this time Clyra Medical Technologies Inc. BioLargo said Clyra has secured an exclusive distribution agreement with Al-Hikma FZCO.

Based in Dubai, United Arab Emirates, Al-Hikma FZCO will be responsible for the commercialization of ViaCLYR™ across an extensive region that includes the Gulf Cooperation Council, the Levant, North Africa, and several neighboring markets, the release said. The agreement incorporates standard international distribution terms, such as exclusivity based on performance metrics and mutual cooperation and protections typical in such agreements. Efforts to meet country-level regulatory requirements for commercial sales have already commenced in crucial areas through collaborative efforts between Clyra and Al-Hikma FZCO.

ViaCLYR™, developed by Clyra Medical, is an advanced wound irrigation solution that uses the company’s proprietary Clyrasept™ Copper-Iodine Complex Solution (CICS) technology, celebrated for its broad-spectrum antimicrobial properties, biocompatibility, and support of natural healing processes.

"Al-Hikma FZCO is exactly the kind of partner we wanted in this region — established, deeply networked across the Middle East and North Africa, and credible with regulators and the clinical community," Clyra Chief Executive Officer Steve Harrison said. "Their portfolio strength in wound management makes ViaCLYR™ a natural fit, and with regulatory work already in motion we are well positioned to build commercial momentum."

BioLargo Chief Executive Officer Dennis P. Calvert noted, "This agreement meaningfully expands Clyra's international footprint and reflects our strategy of partnering with proven, well-established distributors."

He highlighted Al-Hikma FZCO’s extensive reach, serving a population of over 500 million people in some of the world’s most dynamic healthcare markets.

"Clyra's copper-iodine technology is differentiated and aligned with our mission to bring innovative, high-quality healthcare products to the communities we serve," said Dr. Ali Farooq Abdul-Qader, founder and group CEO of Al-Hikma FZCO.

ViaCLYR™ utilizes Clyra's proprietary Copper-Iodine Complex Solution (CICS), known as Clyrasept™, which offers rapid, broad-spectrum antimicrobial activity while remaining biocompatible with human tissues. Key clinical observations included rapid reduction in wound fluid discharge, noticeable increase in healing activity early in treatment, rapid closure of wound tunnels, improved wound edge appearance, dramatic transformation of chronic, scarred wounds to actively healing wounds, and significant reduction in wound size and depth, especially in pressure injuries.

Described as a highly effective, tissue-safe, long-acting wound irrigation solution suitable for a wide range of acute and chronic wounds and burns, ViaCLYR™ is 510(k) cleared by the FDA and indicated for use in both acute and chronic wounds, boasting extremely high antimicrobial activity and sustained efficacy for up to 72 hours.

Expert Praises Co.'s Process

¹Technical Analyst John Newell of John Newell & Associates recently provided insights into BioLargo, a technology incubator actively addressing significant healthcare and environmental challenges. In his analysis for Streetwise Reports on March 11, Newell emphasized the progress BioLargo has made, particularly with its Clyra technology, which is increasingly recognized in the healthcare sector for its ability to eradicate pathogens without damaging human tissue. This capability makes Clyra an essential player in the fight against hospital-acquired infections and antibiotic resistance.

BioLargo's strategy includes advancing its proprietary technologies through rigorous scientific validation and forming partnerships with established entities to expand these innovations. The company's diverse portfolio includes solutions for advanced water treatment, environmental remediation, air quality control, long-duration energy storage, and medical technologies. Notably, Clyra Medical Technologies stands out for its copper-iodine antimicrobial solutions that remain effective for up to 72 hours and are non-cytotoxic, making them ideal for managing wounds and surgical infections. Clyra's flagship product, ViaCLYR, has secured FDA 510(k) clearance, enhancing its distribution through established medical device channels. The technology, protected by approximately 40 issued and pending patents, is available in various formats such as liquids, powders, hydrogels, and antimicrobial dressings, as noted by Newell.

In addition to its medical advancements, BioLargo is developing a long-duration energy storage system known as the Cellinity™ battery. This innovation aims to surpass the limitations of traditional lithium-ion batteries for grid-scale applications, utilizing earth-abundant materials to ensure longevity. The company plans to license this technology and collaborate with manufacturing facilities for its production.

Newell described BioLargo as a Speculative Buy, citing multiple potential catalysts across its technology platforms. The company's methodical approach to commercialization and partnership is well-suited to meet the increasing demands for advanced healthcare solutions and sustainable energy storage.

Oak Ridge Financial Analyst Richard Ryan provided an update on BioLargo on March 6. He explained, "BLGO's business model is a hub and spoke format — invent/acquire a product, prototype/prove it out, partner with necessary third parties, and commercialize." He maintains a Buy rating on the stock, noting that by commercializing technologies through operating subsidiaries, BioLargo effectively diversifies risk, retains significant ownership in its segments, and delivers solutions to diversified, high-growth end markets.

Aging Populace Creates Need for Improvements

According to a report by Future Market Insights, the global market for anti-biofilm wound dressings is projected to experience robust growth, with an expected compound annual growth rate (CAGR) of 9.8% from 2025 to 2035. The market size is anticipated to increase from US$943.5 million to US$2.4 billion during this period. This growth is largely attributed to the rising incidence of surgical site infections, diabetic ulcers, and chronic wounds. Biofilms, which are known to hinder healing and contribute to antibiotic resistance, are also a significant factor driving the demand for advanced wound care solutions. [OWNERSHIP_CHART-6976]

In the United States, the market is set to expand at a CAGR of 9.3%, fueled by an aging population, the increasing prevalence of chronic wounds, advancements in medical technology, and government-led initiatives aimed at improving healthcare outcomes.

In a related market sector, Fact.MR, a global provider of market intelligence, has evaluated the global wound irrigation solution market. The market was valued at US$732 million in 2024 and is forecasted to grow at a CAGR of 3.4%, reaching US$1.02 billion by the end of 2034. This growth is driven by the increasing prevalence of chronic diseases such as diabetes and vascular conditions, which escalate the need for effective wound care. Hospitals and clinics are intensifying the adoption of wound irrigation protocols to mitigate the risk of surgical site infections, which are a major concern in healthcare settings.

On any given day, about 1 in 31 hospital patients is affected by at least one HAI, according to the Centers for Disease Control and Prevention. These infections not only lead to significant morbidity and mortality but also impose substantial financial burdens on the healthcare system. The growing awareness and consequent measures to prevent such infections are further propelling the demand for advanced wound care and irrigation solutions.

Ownership and Share Structure²

About 19.3% of BioLargo is owned by insiders and management. About 0.0367% is held by institutions with13F-disclosed institutional holdings only. The rest, 80.66%, is retail.

Its market cap is US$50.34 million, with about 320.88 million shares outstanding and about 276.31 million free-floating. It trades in a 52-week range of US$0.14 and US$0.26.

Important Disclosures:

BioLargo Inc. is a billboard sponsor of Streetwise Reports and pays SWR a monthly sponsorship fee between US$3,000 and US$6,000.
As of the date of this article, officers, contractors, shareholders, and/or employees of Streetwise Reports LLC (including members of their household) own securities of BioLargo Inc.
Steve Sobek wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee.
This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

For additional disclosures, please click here.

Disclosure for the quote from the John Newell article published on March 11, 2026

For the quoted article (published on March 11, 2026), the Company has paid Street Smart, an affiliate of Streetwise Reports, US$2,550.
Author Certification and Compensation: [John Newell of John Newell and Associates] was retained and compensated as an independent contractor by Street Smart for writing this article. Mr. Newell holds a Chartered Investment Management (CIM) designation (2015) and a U.S. Portfolio Manager designation (2015). The recommendations and opinions expressed in this content reflect the personal, independent, and objective views of the author regarding any and all of the companies discussed. No part of the compensation received by the author was, is, or will be directly or indirectly tied to the specific recommendations or views expressed.

John Newell Disclaimer

As always it is important to note that investing in precious metals like silver carries risks, and market conditions can change violently with shock and awe tactics, that we have seen over the past 20 years. Before making any investment decisions, it's advisable consult with a financial advisor if needed. Also the practice of conducting thorough research and to consider your investment goals and risk tolerance.

Ownership and Share Structure Information

The information listed above was updated on the date this article was published and was compiled from information from the company and various other data providers.

( Companies Mentioned: BLGO:OTCQX, )

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Ownership & Share Information¹

Ownership & Share Information¹

Ownership & Share Information²

Ownership & Share Information¹

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Ownership & Share Structure¹

Ownership & Share Information¹

Ownership & Share Information²

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