Category: Health

GeoVax Labs (GOVX) – GeoVax Presents Data On New Single-Dose Mpox Vaccine

Posted on by [email protected]


Wednesday, April 08, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Preclinical Study Compared Single-Dose MVA With Two-Dose Standard Vaccine. GeoVax presented preclinical data at the World Vaccine Congress Washington 2026 comparing its current pre-Phase-3 GEO-MVA vaccine for Mpox with its new MVA-X version. The new MVA-X includes a peptide sequence that elicits a strong T-cell response that requires only one dose to achieve protection instead of two.

Immune Checkpoint Modulation Improves The Response. The new MVA-X includes an immunomodulatory peptide designed to improve T-cell responses. The peptide modulates the PD-1 immune checkpoint pathway to block inhibitory signaling to magnify T-cell activation, improve the durability of the T-cell response, and enhance immune memory.


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Release – NeuroSense Therapeutics Announces Receipt of Nasdaq Notifications Regarding Minimum Bid Price and Market Value Requirements

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Research News and Market Data on NRSN

  • Notifications have no immediate effect on the listing or trading of the Company’s securities on Nasdaq
  • Nasdaq has provided the Company until September 29, 2026 to regain compliance with both requirements
  • The Company is actively evaluating actions to regain compliance, with a clear focus on initiatives that are aligned with and supportive of long-term shareholder value

CAMBRIDGE, Mass., April 3, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (“NeuroSense” or the “Company”), a late-stage clinical biotechnology company developing treatments for severe neurodegenerative diseases, today announced that it received two notification letters from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) on April 2, 2026, indicating that the Company is not in compliance with certain continued listing requirements of The Nasdaq Capital Market.

The first notification letter indicated that the Company is not in compliance with Nasdaq Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid price of $1.00 per share, since the closing bid price of the Company’s ordinary shares was below $1.00 per share for 30 consecutive business days, from February 18, 2026 through March 31, 2026.

The second notification letter indicated that the Company is not in compliance with Nasdaq Listing Rule 5550(b)(2), which requires listed securities to maintain a minimum market value of listed securities (“MVLS”) of $35 million, since the Company’s MVLS was below $35 million for 30 consecutive business days over the same period.

These notifications have no immediate effect on the listing or trading of the Company’s securities on Nasdaq. The Company’s ordinary shares and warrants will continue to trade on The Nasdaq Capital Market under the symbols “NRSN” and “NRSNW,” respectively.

In accordance with Nasdaq Listing Rules, the Company has a compliance period of 180 calendar days, or until September 29, 2026, to regain compliance with both the minimum bid price requirement and the MVLS requirement. To regain compliance, the Company’s ordinary shares must maintain a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days, and the Company’s MVLS must close at $35 million or more for a minimum of 10 consecutive business days, in each case subject to Nasdaq’s discretion.

The Company continues to actively monitor the closing bid price of its ordinary shares and its MVLS and is evaluating available actions to regain compliance with Nasdaq’s continued listing requirements, with a clear focus on initiatives that support and enhance long-term shareholder value. 

About NeuroSense

NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and Parkinson’s disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense’s strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.

Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of regulatory filings, reporting of data, meetings and regulatory decisions. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the uncertainty regarding the timing of regulatory filings, meetings and regulatory decisions; outcomes and the timing of current and future clinical trials; the risk the PrimeC will not advance towards later-stage development, timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 31, 2026 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

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SOURCE NeuroSense

For further information: For further information: [email protected], +972 (0)9 799 6183

Release – GeoVax Highlights Single-Dose Mpox Vaccine Data at World Vaccine Congress 2026

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Research News and Market Data on GOVX

MVA-X Platform Demonstrates Single-Dose Durable Protection Comparable to Two-Dose Regimen

ATLANTA, GA, April 2, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and cancer, today highlighted preclinical data presented at the World Vaccine Congress Washington 2026 supporting the potential for a single-dose Modified Vaccinia Ankara (MVA)-based mpox vaccine. The data demonstrate that a novel MVA vaccine construct incorporating an immunomodulatory peptide (“MVA-X”) achieved protective efficacy, comparable to the traditional two-dose MVA regimen, in a murine orthopoxvirus challenge model.

  • The presentation, titled “Next-Generation MVA Mpox Vaccines: Harnessing an Immunomodulatory Peptide for Single-Dose Efficacy,” was delivered by Heather Koehler, Ph.D., of Washington State University, during the Immune Profiling track on April 1, 2026.
  • Single-dose efficacy: the MVA-X vaccine construct achieved complete protection comparable to a two-dose MVA vaccine regimen in a lethal orthopox challenge model, while a single-administration of MVA showed only partial protection.
  • Durable protection: Protective immunity was maintained through Day 150 post-vaccination, with 100% survival observed in both MVA-X (single-dose) and two-dose MVA groups.
  • Robust viral control: MVA-X demonstrated significant reduction in lung viral burden, comparable to the two-dose MVA regimen.
  • Improved clinical outcomes: MVA-X vaccinated animals exhibited minimal weight loss, reduced disease severity, and preserved lung structure.
  • T cell-driven immunity: Protection in MVA-X vaccinated animals was independent of neutralizing antibodies, supported by enhanced CD4+ and CD8+ T cell responses.

Mechanistic Innovation

The MVA-X construct incorporates a peptide designed to transiently modulate the PD-1 immune checkpoint pathway, enhancing T cell activation and durability of immune response during vaccination.

This approach enables:

  • Stronger and more sustained T cell responses
  • Enhanced immune memory
  • Potential for durable protection with fewer doses

This represents a novel application of immune checkpoint modulation within vaccine design.

“These findings provide an important proof-of-concept that the performance of MVA-based vaccines can be enhanced to potentially achieve single-dose protection,” said Mark Newman, Ph.D., Chief Scientific Officer of GeoVax. “The preclinical data demonstrates a clear biological signal that supports continued exploration of immune-enhanced MVA constructs.”

David A. Dodd, Chairman and Chief Executive Officer of GeoVax, added: “As mpox continues to emerge as a recurring global health and biodefense concern, the need for vaccines that are both durable and rapidly deployable has become increasingly clear. An MVA-X vaccine may offer the opportunity to meaningfully improve vaccination coverage, compliance, and outbreak response – particularly in resource-constrained or high-risk environments.”

Dodd further noted: “These results reinforce the strength and flexibility of the MVA platform that underpins our GEO-MVA program. With a defined regulatory pathway in place and preparations underway to initiate a Phase 3 immune bridging study, GeoVax is focused on advancing an MVA vaccine designed to expand global supply, support public health preparedness, and address the limitations of existing options.”

Strategic Context

  • Supports Single-Dose Strategy for MVA-based immunization: Potential to simplify vaccination and improve real-world deployment
  • Aligns with Market Need: Potential to addresses drawbacks of current mpox vaccines, including multi-dose requirements and durability

About the Study

The study evaluated MVA-X, an MVA-based vaccine incorporating an immunomodulatory peptide sequence designed to enhance T cell responses. In murine models, animals were challenged with high-dose vaccinia virus at multiple timepoints (Days 55, 90, and 150), with outcomes including survival, viral load, clinical pathology, and immune response.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected]

Release – Cocrystal Pharma Receives FDA Fast Track Designation for CDI-988 for Norovirus Infection Treatment and Preventive

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Research News and Market Data on COCP

April 02, 2026

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  • FDA Fast Track designation supports accelerated development and expedites regulatory review
  • Norovirus is responsible for an estimated 685 million global cases each year and approximately $60 billion in worldwide economic impact

BOTHELL, Wash., April 02, 2026 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its oral, direct-acting protease inhibitor, CDI-988, the first oral antiviral candidate being developed for treatment and prophylaxis of norovirus infection.

FDA Fast Track designation aims to facilitate the development and accelerate the review process for drugs that treat serious conditions and address unmet medical needs. The designation enables early and frequent communication with the FDA throughout the development process, allows for rolling review of a New Drug Application (NDA), and may qualify a product for Priority Review at the time of NDA submission.

CDI-988 was designed and developed as an inhibitor of a highly conserved region of noroviruses, coronaviruses, and other 3CL viral proteases. A Phase 1b norovirus challenge study is underway at Emory University School of Medicine to evaluate CDI-988 to both prevent and treat norovirus infection.

“We are pleased that the FDA has granted Fast Track designation for CDI-988, marking a significant milestone for Cocrystal and a critical step toward helping patients with norovirus,” said Sam Lee, Ph.D., President and co‑CEO of Cocrystal Pharma. “Norovirus infections are highly contagious and can cause acute gastroenteritis, resulting in nausea, vomiting, stomach pain, diarrhea, fatigue, fever and dehydration. While most people recover within a few days, immunocompromised individuals can experience chronic, long-term norovirus infections that can persist for weeks to years. Based on compelling data generated to date, we believe that CDI-988 has the potential to both prevent and treat norovirus infection.

“This designation further validates using our unique structure-based drug discovery technology to design pan-viral antivirals that are effective new treatment options,” added Dr. Lee. “We look forward to more frequent interactions with the FDA with the goal of delivering the first therapeutic and preventive medicine to treat norovirus infections.”

About Norovirus

Norovirus is a leading cause of acute gastroenteritis, responsible for an estimated 685 million global cases each year and approximately $60 billion in worldwide economic impact. In the United States alone, the virus is associated with 21 million infections annually, resulting in around 109,000 hospitalizations, 465,000 emergency department visits, and 900 deaths. The estimated annual economic burden in the U.S. exceeds $10.6 billion. In developing nations, norovirus contributes to up to 1.1 million hospitalizations and 218,000 pediatric deaths each year.

Cocrystal’s ongoing Phase 1b randomized, double‑blind, placebo‑controlled challenge study (NCT07198139) at Emory University School of Medicine will evaluate CDI‑988 in up to 40 healthy adults. The primary endpoint is a reduction in the incidence of clinical symptoms, with secondary endpoints assessing viral shedding, disease severity, safety, and pharmacokinetics.

About Cocrystal Pharma’s Structure-Based Drug Discovery Platform

Cocrystal is leveraging its structure‑based drug discovery platform technology to design next‑generation antiviral candidates that precisely target viral replication mechanisms. By binding to highly conserved regions of viral enzymes, the Company’s compounds aim to maintain potency against mutating strains while minimizing off‑target effects, offering potentially safer, broad‑spectrum antiviral solutions. This approach streamlines candidate identification and optimization, enabling more rapid progression of promising therapies with robust resistance and safety profiles.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2), and rhinoviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create viable antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans for more frequent interactions with the FDA and our goals with respect to our norovirus product candidate. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations, the progress and results of the studies including any adverse findings or delays, the ability of us and our CROs to recruit volunteers for, and to otherwise proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes and any adverse developments which may arise therefrom, and general economic adverse effects from the ongoing conflict with Iran. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
[email protected]

# # #

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Source: Cocrystal Pharma, Inc.

Released April 2, 2026

The Pharma Tariff Playbook: How Drug Companies Can Navigate the Administration’s Latest Pricing Push

Posted on by [email protected]

The Trump administration is preparing to impose tariffs of up to 100% on branded pharmaceutical drugs — but the details buried beneath that headline number tell a more nuanced story, one that comes with multiple off-ramps for companies willing to engage. According to a draft document obtained by CNBC, the proposal is not final, and the framework is structured less as a blanket penalty and more as a tiered system designed to reward companies that move quickly and strategically.

Understanding the structure matters more than reacting to the headline.

How the Framework Actually Works

Under the draft proposal, patented medications and their active pharmaceutical ingredients would face a 100% tariff — but that rate applies specifically to companies that have neither struck deals with the administration nor committed to onshoring US manufacturing. Companies that are actively moving production to the United States would face a significantly lower 20% rate, with a four-year runway before that escalates. Companies that have already executed pricing deals with the Department of Health and Human Services — or are currently in active negotiations — are exempt from additional tariffs entirely. Generic drugs face zero new tariffs under the proposal. Separate negotiated rates also exist for the EU, Japan, South Korea, Switzerland, and the UK through bilateral arrangements.

The architecture of this plan is deliberate. The 100% figure is the ceiling for the least cooperative scenario, not the baseline.

The Early Movers Are Already Protected

Since November, more than a dozen major drugmakers — including Eli Lilly, Pfizer, and Novo Nordisk — have signed agreements with the Trump administration under the “most favored nation” pricing policy, which ties US drug prices to lower international rates. Those deals came with a three-year tariff exemption, meaning the companies that read the room early are sitting out this round entirely. Lilly in particular has had an extraordinarily active week — closing a $6.3 billion acquisition of Centessa Pharmaceuticals and receiving FDA approval for its oral GLP-1 drug Foundayo — operating from a position of policy stability that its peers without deals don’t currently enjoy.

The Roadmap for Smaller Companies

For small and microcap biopharma companies, the key takeaway is that the exemption pathways are real and accessible. The administration has structured this to incentivize negotiation, not to punish innovation. Companies currently in active HHS discussions face no additional tariffs — which means initiating that conversation sooner rather than later is the most direct hedge available.

The generic drug exemption also provides meaningful relief for a significant portion of the smaller specialty pharma universe. And for companies earlier in their development cycle — clinical-stage biotechs without commercial products yet — the immediate operational impact is limited while the policy landscape continues to develop.

The onshoring incentive embedded in the framework also opens a longer-term strategic conversation. Federal policy is clearly moving toward rewarding domestic manufacturing investment, and companies that begin building that into their operational planning now will be better positioned competitively as the rules solidify.

The Bigger Picture

This proposal is part of a broader administration push to restructure how drugs are priced and where they are made in the United States. The direction of travel is clear even if the final details are not. For biopharma companies of every size, the companies that treat this as a strategic planning exercise rather than a political headline will be the ones best positioned when the policy finalizes.

The playbook exists. The question is who runs it first.

Release – Ocugen Announces Early Completion of Dosing in Phase 2/3 Pivotal Confirmatory Trial of OCU410ST for Stargardt Disease

Posted on by [email protected]

Research News and Market Data on OCGN

April 1, 2026

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  • GARDian3 trial enrollment and dosing completed (N=63) in less than nine months
  • Topline results expected in 2Q27 with BLA to follow by mid-2027
  • OCU410ST represents a potential first-in-class, one-time modifier gene therapy for all ABCA4-associated retinopathies

MALVERN, Pa., April 01, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that dosing has been successfully completed ahead of schedule in the Phase 2/3 GARDian3 pivotal confirmatory clinical trial for OCU410ST (AAV5-hRORA)—a modifier gene therapy candidate developed for all Stargardt disease (ABCA4-associated retinopathies).

“This enrollment milestone for a pivotal trial underscores the tremendous progress our team is making toward bringing a transformative therapy to people living with multiple ABCA4-related gene mutations including Stargardt disease,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-founder of Ocugen. “The efficient and accelerated execution of this trial reflects the strong engagement of investigators and patients. It reinforces our confidence in OCU410ST as a potential one-time treatment option for all Stargardt patients who are desperately seeking rescue from blindness with no approved therapies to date.”

“I am encouraged by the enthusiastic response and rapid enrollment in the GARDian3 registrational clinical trial for Stargardt disease—a devastating pediatric-onset retinal disorder affecting approximately 100,000 patients in the U.S. and Europe,” said Dr. Huma Qamar, Chief Medical Officer of Ocugen. “Our trial encompasses pediatric to adult, and early to advanced stage subjects to address critical unmet medical need.”

“As a treating retina specialist, I see how the natural history of Stargardt disease leads to relentless enlargement of atrophic lesions and gradual loss of central visual acuity, often at a young age,” said Christine Kay, MD, Vitreo Retinal Associates, Florida and a principal investigator in the GARDian3 trial. “The opportunity to intervene at an early stage of disease with a one-time subretinal gene therapy like OCU410ST that can potentially slow lesion growth, preserve visual function over time, and save vision before irreversible damage represents an exciting and much needed shift from watching patients decline to proactively altering the course of their disease.”

GARDian3 is a multicenter, randomized, masked, pivotal Phase 2/3 confirmatory study designed to evaluate the efficacy and safety of OCU410ST in patients with all mutations of Stargardt disease. OCU410ST is administered as a single subretinal injection, leveraging Ocugen’s AAV5-based modifier gene therapy platform to provide durable expression of hRORA in the retina with the goal of slowing or halting progressive macular degeneration and preserving visual function.

The Phase 2/3 study enrolled 63 participants diagnosed with Stargardt disease. Subjects randomized to treatment group received a one-time subretinal injection of OCU410ST (3 × 1010 vector genomes/eye) in the eye with poorer visual acuity, while untreated control group did not receive any treatment. The primary objective of the trial is to evaluate the reduction in atrophic lesion size at 12 months. Key secondary endpoints include improvements in best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA), compared to controls. Observational endpoints include preservation of Ellipsoid Zone (EZ) that correlates to visual function. While demonstrating functional benefit via visual acuity within 12 months can be challenging due to the disease’s natural history, it is believed that preservation of EZ will serve as a meaningful and early indicator of therapeutic benefit.

Interim analysis will be performed in the third quarter of 2026 when 24 subjects complete the 8-month follow-up visit post-OCU410ST treatment. Data from the one-year follow-up will be used to support the company’s planned Biologics License Application (BLA).

OCU410ST maintains a favorable safety and tolerability profile with no serious adverse events or adverse events of special interest, including ischemic optic neuropathy, vasculitis, intraocular inflammation, endophthalmitis or choroidal neovascularization.

The OCU410ST Phase 2/3 pivotal confirmatory trial represents Ocugen’s second late-stage clinical program. Ocugen plans to submit the BLA for OCU410ST mid-2027 in alignment with its strategic goal of filing three BLAs by 2028.

About OCU410ST
OCU410ST utilizes an AAV5 delivery platform to deliver the RORA (RAR-Related Orphan Receptor A) gene to the retina. By restoring nuclear hormone receptor signaling, OCU410ST addresses pathophysiological pathways linked to Stargardt disease, including lipofuscin formation, oxidative stress, complement activation, inflammation, and photoreceptor survival networks independent of the underlying ABCA4 genotype.

In a 12-month Phase 1 (GARDian 1) trial, evaluable treated eyes showed a 54% reduction in atrophic lesion growth versus untreated fellow eyes, with slower lesion expansion and improvement in visual acuity among evaluable patients. Treated eyes gained an average of 6 letters in BCVA, while untreated fellow eyes declined by 1.5 letters, and all treated eyes either stabilized or improved in visual acuity. In evaluable subjects ellipsoid zone (EZ) loss rate was 116% slower in OCU410ST-treated eyes vs untreated fellow eyes at 12 months. Data indicates preservation or stabilization of photoreceptor integrity in treated eyes. No drug-related serious adverse events or adverse events of special interest were observed.

About Stargardt Disease
Stargardt disease type 1 is a genetic eye disorder caused by biallelic mutations in the ABCA4 gene. This condition leads to progressive macular degeneration, with onset typically occurring during childhood or adolescence. Affected patients experience progressive central vision loss while peripheral vision is usually preserved. There are currently no FDA-approved treatments for this orphan indication.

About Ocugen, Inc.
Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU410ST to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
[email protected]

Korsana Biosciences Emerges from Cyclerion Merger with $380 Million and a Next-Generation Shot at Alzheimer’s

Posted on by [email protected]

A small-cap reverse merger is giving birth to one of the better-funded Alzheimer’s plays to hit the public markets in recent memory. Cyclerion Therapeutics (Nasdaq: CYCN) and privately-held Korsana Biosciences announced a definitive all-stock merger agreement that will effectively hand the Nasdaq listing to Korsana, with the combined company rebranding as Korsana Biosciences and trading under the new ticker “KRSA.”

The deal comes packaged with serious capital behind it. Concurrent with the merger, Korsana secured approximately $380 million in a heavily oversubscribed private financing round led by Fairmount and Venrock Healthcare Capital Partners, with participation from a deep bench of institutional names including General Atlantic, Wellington Management, RA Capital Management, RTW Investments, and J.P. Morgan Life Sciences Private Capital, among others. That kind of syndicate doesn’t assemble around a science project — it assembles around conviction.

The combined company’s cash position at closing is expected to fund operations into 2029, providing runway through multiple critical clinical milestones.

The Science Behind the Capital

Korsana’s lead program, KRSA-028, is a next-generation shuttled monoclonal antibody targeting amyloid beta for the treatment of Alzheimer’s disease — the same mechanism that underpins approved therapies like lecanemab and donanemab, but engineered to address their most significant limitations.

The differentiation lies in Korsana’s proprietary Therapeutic Targeting platform, known as THETA™. The platform incorporates clinically validated transferrin receptor (TfR1) and Fc engineering designed to dramatically improve brain delivery — getting more drug where it needs to go. KRSA-028 was specifically designed to increase amyloid plaque clearance while reducing the rate of amyloid-related imaging abnormalities (ARIA), a safety concern that has complicated the commercial rollout of first-generation anti-amyloid therapies. It also targets a low-volume subcutaneous administration route, a meaningful convenience advantage over current IV-infusion dependent treatments.

Korsana is the seventh company to launch with assets discovered through Paragon Therapeutics, a track record that adds credibility to the platform’s pedigree.

Key Milestones on the Horizon

The $380 million in financing is structured to carry Korsana through two pivotal data readouts: Phase 1 healthy volunteer data from KRSA-028 expected in mid-2027, and interim proof-of-concept data measuring amyloid plaque clearance in Alzheimer’s patients expected by the end of 2027. If those readouts deliver, the story accelerates significantly.

The Mechanics of the Deal

Under the merger terms, existing Cyclerion shareholders will own approximately 1.5% of the combined company, with Korsana stockholders — inclusive of the private placement participants — holding the remaining 98.5%. That’s a near-total reset of the cap table, which is standard for this type of reverse merger structure where the private company is clearly the operating entity driving the deal.

The transaction has been approved by both boards and is expected to close in the third quarter of 2026, subject to shareholder approvals and customary regulatory conditions including HSR clearance.

Wedbush Securities acted as exclusive strategic financial advisor to Korsana. Jefferies, TD Cowen, Stifel, and UBS served as placement agents. Ropes & Gray advised Cyclerion.

For small and microcap investors, the Korsana story is worth tracking closely. A well-capitalized, differentiated Alzheimer’s platform with a clear clinical timeline and institutional backing is exactly the kind of setup that can move quickly once data starts flowing.

Cadrenal Therapeutics (CVKD) – Cadrenal Reports FY2025 With Clinical Progress

Posted on by [email protected]


Wednesday, April 01, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Progress On CAD-1005 Reported With FY2025 Results. Cadrenal reported a loss for 4Q25 of $3.0 million or $(1.42) per share and a FY2025 loss of $13.2 million or $(6.64) per share. Importantly, it recently held its End-Of-Phase 2 meeting with the FDA to receive guidance for the planned Phase 3 trial for CAD-1005 in HIT (heparin-induced thrombocytopenia). The company had cash and equivalents of $4.0 million on December 31, 2025.

Lead Indication Reported Phase 2 Data. As discussed in our Research Note on February 25, Cadrenal reported results from its Phase 2 study of CAD-1005 in HIT. The trial was designed to show CAD-1005 improved platelet recovery and tested platelet count recovery as a biomarker for thrombosis and outcome. The data did not show a correlation between platelet count normalization and thrombotic events, but did show an important reduction in thrombotic events exceeding 25% in the CAD-1005 treatment arm compared with placebo.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

MAIA Biotechnology (MAIA) – MAIA Reports Two-Year Survival Data At Medical Conference

Posted on by [email protected]


Wednesday, April 01, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

New Data Presented Shows Long-Term Survival. MAIA presented data from its Phase 2 THIO-101 trial at the European Lung Cancer Congress 2026 (ELCC) held recently in Copenhagen, Denmark. The presentation included data from patients with non-small cell lung cancer (NSCLC) who had relapsed after treatment with standard chemotherapy. Data from 8 patients showed survival exceeding 2 years and greatly exceeded the expected survival for patients at their stage of disease.

Phase 2 Trial Design. THIO-101 was designed in three stages. Part A was basic safety, and Part B was a dose-finding stage. These two stages treated a total of 79 patients. The ongoing Part C is an expansion stage enrolling up to 48 participants in Asia and Europe. The patients are treated with ateganosine (aka THIO) followed by cemiplimab (Libtayo, from Regeneron). 


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

The GLP-1 Race Goes Oral: FDA Approves Lilly’s Foundayo, Reshaping the Obesity Market and the Competitive Landscape

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The FDA approved Eli Lilly’s (NYSE: LLY) Foundayo (orforglipron) today, a once-daily oral GLP-1 receptor agonist for adults with obesity or overweight with weight-related medical conditions. The approval marks a pivotal shift in one of the fastest-growing drug categories in history — and for small and microcap investors, the ripple effects are worth paying close attention to.

Foundayo joins Novo Nordisk’s Wegovy pill as the only two oral GLP-1 medications with FDA approval, but Lilly is positioning its drug as the more flexible option. Unlike the Wegovy pill, which must be taken in the morning 30 minutes before eating or drinking, Foundayo can be taken at any time of day and without restrictions on food and water.

It’s worth noting that Lilly is having one of the busiest 24-hour stretches in recent memory. Yesterday, the company announced a definitive agreement to acquire Centessa Pharmaceuticals for up to $47.00 per share — a deal valued at approximately $7.8 billion — to bolster its neuroscience pipeline in sleep-wake disorders. [Related: Eli Lilly Banks $6.3 Billion on Sleep Science with Centessa Pharmaceuticals Acquisition] Today’s FDA approval underscores just how aggressively Lilly is moving across multiple therapeutic fronts simultaneously.

The Numbers Behind the Pill

In the ATTAIN-1 trial, patients receiving the highest dose who remained on treatment lost a mean of 27.3 pounds (12.4%) compared with 2.2 pounds (0.9%) among those receiving placebo. That’s meaningfully below the 20%+ weight loss seen with injectable GLP-1s like Zepbound, but Lilly isn’t positioning this as a replacement — it’s positioning it as an on-ramp.

Analysts estimate Foundayo sales will reach $14.79 billion by 2030, compared to expectations of $24.68 billion for Zepbound. On pricing, eligible people with commercial insurance may pay as little as $25 per month, self-pay patients can access it starting at $149 per month, and eligible Medicare Part D patients may access it for $50 per month beginning July 1, 2026.

The FDA reviewed the Foundayo application in just 50 days under a Commissioner’s National Priority Voucher pilot program, making it the fastest approval of a new molecular entity since 2002. That regulatory speed is its own headline.

What This Means for the Broader Market

The oral GLP-1 approval isn’t just a Lilly story — it’s a market structure story. Injectable GLP-1s built a massive but friction-filled market: cold storage requirements, weekly injection routines, and access barriers kept a significant portion of eligible patients on the sidelines. Fewer than 1 in 10 people who could benefit from a GLP-1 are currently taking one. A pill changes that calculus dramatically, and a larger addressable patient pool creates downstream opportunities across the healthcare ecosystem.

For smaller companies building in adjacent spaces — weight management technology platforms, metabolic disease diagnostics, complementary therapeutics — this approval accelerates the market they’re betting on. Novo Nordisk’s early data already suggests the pill is expanding the obesity treatment market rather than simply cannibalizing injectable demand, with more than 600,000 prescriptions for the Wegovy pill recorded in March alone.

The Competitive Pressure Is Real

Lilly’s approval also puts pressure on every company in the obesity space without an oral option. Novo has a head start on the pill market but carries the food and water restriction disadvantage. Other GLP-1 developers — many of them smaller biotechs — now face an even higher innovation bar. The era of “we have a GLP-1” being sufficient is over. Differentiation by mechanism, convenience, side effect profile, or patient population is now the only viable path to relevance.

Lilly expects Foundayo approval in more than 40 countries over the next year and has invested more than $55 billion in manufacturing since 2020 to support global scale — a moat that smaller competitors cannot easily replicate, making niche differentiation even more critical for emerging players.

The oral GLP-1 market is now officially open. The question for small and microcap investors is which companies are building the infrastructure, tools, and therapies that benefit from a world where obesity treatment becomes a daily pill.

Biogen Banks $5.6 Billion on Apellis as Big Pharma M&A Appetite for Biotech Heats Up

Posted on by [email protected]

Biogen (Nasdaq: BIIB) is making its most consequential portfolio move in years, announcing a definitive agreement to acquire Apellis Pharmaceuticals (Nasdaq: APLS) for $41.00 per share in cash — an upfront equity consideration of approximately $5.6 billion — plus a contingent value right (CVR) tied to future sales milestones for its flagship eye disease therapy. The deal closed out March with a statement: big pharma is hungry, and specialty biotech is on the menu.

The transaction carries an 86% premium to Apellis’ 90-day volume-weighted average stock price and a 35% premium to its 52-week high. It is expected to close in the second quarter of 2026.

What Biogen Is Getting

At the center of the deal are two commercialized complement-targeting therapies: SYFOVRE® (pegcetacoplan injection), approved for geographic atrophy (GA) secondary to age-related macular degeneration, and EMPAVELI® (pegcetacoplan), approved across three rare immune-mediated conditions — C3 glomerulopathy (C3G), primary IC-MPGN, and paroxysmal nocturnal hemoglobinuria (PNH).

Together, the two drugs generated $689 million in combined net product revenue in 2025, with growth expected in the mid-to-high teens annually through at least 2028. For a company navigating revenue headwinds from its legacy MS portfolio, that near-term visibility is exactly what Biogen needed.

SYFOVRE holds particular strategic weight as the first-ever approved therapy for geographic atrophy — a progressive retinal disease affecting more than five million people globally. Long-term efficacy data shows the drug can delay GA lesion progression by approximately 1.5 years in key patient populations, giving the asset durable commercial runway. The GA space is one that smaller innovators are also actively pursuing. Ocugen (Nasdaq: OCGN), is developing a gene therapy approach targeting inherited retinal diseases — the kind of differentiated, mechanism-driven science that has increasingly attracted large-cap attention.

The Nephrology Angle

Beyond the immediate revenue story, the strategic rationale runs deeper into kidney disease. Apellis brings an established nephrology sales infrastructure that Biogen intends to leverage for felzartamab, its Phase 3 kidney disease candidate with a first trial readout expected in the first half of 2027.

EMPAVELI’s rare kidney disease approvals — including the only FDA-approved treatment for pediatric patients with C3G and the first approval for post-transplant C3G recurrence — underscore how defensible rare nephrology positions can be. Two other emerging growth companies are staking ground in adjacent kidney disease spaces: Unicycive Therapeutics (Nasdaq: UNCY), developing oxylanthanum carbonate for hyperphosphatemia in chronic kidney disease patients, and Eledon Pharmaceuticals (Nasdaq: ELDN), advancing therapies focused on reducing kidney transplant rejection. The Biogen-Apellis deal reinforces that nephrology is becoming a high-value destination for large-cap dealmaking.

A Market Signal Worth Noting

The Apellis acquisition didn’t land in a vacuum. Earlier today, Eli Lilly announced a separate agreement to acquire Centessa Pharmaceuticals for up to $47.00 per share — a deal valued at approximately $7.8 billion including contingent payments — to bolster its neuroscience pipeline in sleep-wake disorders. Two major biotech acquisitions announced on the same day signals something broader: pharmaceutical companies with strong balance sheets are actively scanning for de-risked, commercially validated or late-stage assets, and they’re willing to pay premium prices to get them.

For investors tracking small and microcap biotech, that backdrop matters. Companies building real clinical differentiation in immunology, nephrology, and ophthalmology are operating in exactly the spaces that large pharma is now paying billions to enter.

CVR Structure and Financial Outlook

The CVR entitles Apellis shareholders to two potential payments of $2 per share, contingent on SYFOVRE hitting $1.5 billion and $2 billion in annual global net sales between 2027 and 2030. Biogen expects the deal to be increasingly accretive to non-GAAP diluted EPS starting in 2027, with full de-leveraging targeted by end of 2027.

Release – GeoVax Announces a Warrant Inducement Transaction

Posted on by [email protected]

Research News and Market Data on GOVX

ATLANTA, GA – March 31, 2026 (NEWMEDIAWIRE) – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancer, today announced its entry into a warrant inducement agreement with existing healthcare-focused institutional investors of the Company for the immediate exercise of existing warrants (the “Existing Warrants”) to purchase up to 634,658 shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”) at a reduced exercise price of $1.36 for gross cash proceeds of approximately $863,000, before deducting financial advisor fees and other transaction expenses. The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes.

In consideration for the immediate exercise in full of the Existing Warrants, the investor will receive, in a private placement, new unregistered warrants to purchase up to 1,269,316 shares of Common Stock (the “New Warrants”). The New Warrants will have an exercise price of $1.36, will be initially exercisable on the date that shareholder approval of the issuance of the New Warrants is obtained (the “Approval Date”), and will expire five (5) years following the Approval Date. The closing of the warrant inducement transaction is expected to occur on or about April 1, 2026, subject to satisfaction of customary closing conditions.

The private placement of the New Warrants and the shares of Common Stock underlying the New Warrants offered to the institutional investor will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and Regulation D promulgated thereunder. Accordingly, the securities issued in the Concurrent Private Placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the securities in this Offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin(R), a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected]

Release – Cocrystal Pharma Reports 2025 Financial Results and Provides Updates on its Antiviral Drug-Development Programs

Posted on by [email protected]

Research News and Market Data on COCP

March 31, 2026

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  • Phase 1b norovirus challenge study is underway at Emory University School of Medicine
  • CDI-988 is the first oral antiviral candidate being developed for norovirus treatment and prevention
  • No approved treatments or vaccines are available for norovirus infection, posing a significant unmet need and contributing to a global economic burden of $60 billion annually

BOTHELL, Wash., March 31, 2026 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the year ended December 31, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and business activities.

“We are delighted to report that our norovirus human challenge study evaluating efficacy and safety of CDI‑988 is underway at Emory University School of Medicine. In our first cohort, healthy subjects are being inoculated with the GII.2 (Snow Mountain Virus) strain under highly controlled conditions,” said Sam Lee, Ph.D., President and co‑CEO of Cocrystal.

“Norovirus remains a significant and underserved market. Developing an effective norovirus antiviral or vaccine has been challenging due to the high genetic and antigenic diversity of norovirus and lack of simple in vitro cell-based assays and animal model system,” Dr. Lee continued. “Using our proprietary structure‑based drug discovery platform technology, we developed CDI‑988 as a direct‑acting, oral antiviral that targets a highly conserved region of the viral 3CL protease found in all known norovirus strains. As a pan-viral 3CL protease inhibitor, CDI‑988 also holds potential as a broad‑spectrum antiviral effective against coronaviruses.”

“Norovirus outbreaks can strike at any time of year in semi-closed environments such as cruise ships, military settings, and healthcare and assisted-living facilities,” said James Martin, Cocrystal’s CFO and co-CEO. “This constant threat underscores the need for an effective oral treatment and preventive that can be deployed whenever and wherever norovirus infections emerge. With CDI-988, our goal is to provide an easy-to-administer, safe and effective drug to combat these unpredictable outbreaks. We believe CDI‑988 represents a key value-creating opportunity for our Company and our investors.”

The Phase 1b randomized, double-blind, placebo-controlled study will enroll up to 40 subjects. The study’s primary endpoint is efficacy in reducing the incidence of clinical symptoms; secondary endpoints include reduction of viral shedding and disease severity, and safety and pharmacokinetic profiles.

Antiviral Product Pipeline Overview

We leverage our innovative structure-based drug discovery platform technology to develop next-generation, broad-spectrum antivirals that effectively block viral replication. Unlike other drug discovery approaches, our technology identifies compounds that bind to highly conserved regions of viral drug targets, including proteases and replication enzymes. By specifically targeting these essential viral functions, our drug candidates maintain efficacy even as viruses mutate, while simultaneously minimizing off-target interactions that typically lead to adverse side effects. This dual advantage represents a significant breakthrough in antiviral drug development. In addition, our innovative methodology fundamentally transforms the conventional drug discovery paradigm by eliminating the inefficient, resource-intensive cycles of high-throughput compound screening and prolonged hit-to-lead optimization. The result is faster identification of promising candidates with superior resistance profiles and safety characteristics.

Norovirus Program
Norovirus is a common, highly contagious virus that afflicts people of all ages and causes symptoms of acute gastroenteritis including nausea, vomiting, stomach pain and diarrhea, as well as fatigue, fever and dehydration. There are currently no effective treatments or vaccines for norovirus, and the ability to curtail outbreaks is inadequate.

With 685 million global cases annually and a $60 billion worldwide economic impact, norovirus represents one of healthcare’s most pressing unmet needs. In the U.S., noroviruses are responsible for an estimated 21 million infections annually, including an estimated 109,000 hospitalizations, 465,000 emergency department visits and 900 deaths. The annual burden of norovirus to the U.S. is estimated at $10.6 billion. In the developing world, each year noroviruses are responsible for up to 1.1 million hospitalizations and 218,000 pediatric deaths.

Oral protease inhibitor CDI-988 for the treatment of noroviruses and coronaviruses: Our novel, broad-spectrum 3CL protease inhibitor CDI-988 is designed as a potential treatment for noroviruses and coronaviruses. CDI-988 has shown in vitro activity against multiple norovirus strains.

  • In April 2025 we announced that CDI-988 showed superior broad-spectrum antiviral activity against the norovirus GII.17 strain, the most prevalent strain in the U.S. and Europe in 2024-2025.
  • In August 2025 we presented favorable Phase 1 safety and tolerability data from all CDI-988 doses, including a high-dose 1200 mg cohort, at the 2025 Military Health System Research Symposium (MHSRS).
  • In September 2025 we discussed CDI-988’s scientific foundation and clinical progress in an oral presentation at the 9th International Calicivirus Conference, the leading calicivirus scientific meeting.
  • In September 2025 we received a Study May Proceed Letter from the FDA to conduct a Phase 1b challenge study in the U.S. evaluating CDI-988 as a norovirus preventive and treatment.
  • In March 2026 we enrolled the first subjects in our Phase 1b challenge study with the initial cohort evaluating the infectivity rate of the GII.2 challenge inoculum, and subsequent cohorts to be orally administered CDI-988 or placebo.

Influenza Programs
Influenza is a major global health threat that may become more challenging to treat due to the emergence of highly pathogenic avian influenza viruses and resistance to approved influenza antivirals. Currently approved antiviral treatments for influenza are effective but are burdened with significant viral resistance.

Each year approximately 1 billion cases of seasonal influenza, 3-5 million severe illnesses and up to 650,000 deaths are reported worldwide. About 8% of the U.S. population gets sick from flu each season. In addition to the health risk, influenza is responsible for an estimated $10.4 billion in direct medical costs in the U.S. each year.

CC-42344 is our novel PB2 inhibitor that showed excellent in vitro activity against pandemic and seasonal influenza A strains, as well as against strains that are resistant to Tamiflu® and Xofluza®.

  • Oral CC-42344 as a treatment for pandemic and seasonal influenza A
    • In December 2022 we reported favorable Phase 1 safety and tolerability results.
    • In December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, and viral and clinical measurements of CC-42344 in influenza A-infected subjects in the United Kingdom, following authorization from the UK Medicines and Healthcare Products Regulatory Agency.
    • In May 2025 we reported that CC-42344 was shown to be active against the highly pathogenic 2024 Texas H5N1 avian influenza strain.
    • In November 2025 an initial Phase 2a study was completed, with CC-42344 showing a favorable safety and tolerability profile with no serious adverse events and no drug-related discontinuations by study participants. Efficacy analyses were not reported due to issues with trial conduct.
    • We plan to continue development of oral CC-42344 as a treatment for pandemic and seasonal influenza A with an additional Phase 2a study.
  • Inhaled CC-42344 as prophylaxis and treatment for pandemic and seasonal influenza A
    • Our preclinical testing showed superior pulmonary pharmacology with CC-42344, including high exposure to drug and a long half-life.
    • We have developed a dry powder inhalation formulation and have completed toxicology studies.
  • Influenza A/B program
    • In October 2025 we received a $500,000 Small Business Innovation Research Phase I award from the NIH’s National Institute of Allergy and Infectious Diseases to support the development of a novel, broad-spectrum lead candidate targeting the influenza A/B polymerase complex.

SARS-CoV-2 and Other Coronavirus Program
By targeting viral replication enzymes and proteases, we believe it is possible to develop effective treatments for all diseases caused by coronaviruses including SARS-CoV-2 and its variants, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome. CDI-988 showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses, as well as against noroviruses. By the end of 2031, the global COVID-19 therapeutics market is estimated to exceed $16 billion annually.

Oral protease inhibitor CDI-988 for the treatment of coronaviruses and noroviruses: CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and demonstrated a favorable safety profile and pharmacokinetic properties.

  • In August 2025 we presented favorable safety and tolerability Phase 1 data from all CDI-988 doses, including a high-dose 1200 mg cohort, at the MHSRS.
  • We are currently pursuing further development of CDI-988 as a prophylaxis and treatment for norovirus and remain optimistic about its viability as a treatment for coronaviruses.

2025 Financial Results

Research and development expenses for 2025 were $5.1 million compared with $12.5 million for 2024, with the decrease primarily due to lower costs with the winddown of the Phase 2a influenza study and reduction in employee-related expenses. General and administrative expenses for 2025 were $4.0 million compared with $5.3 million for 2024, with the decrease primarily due to a reduction in compensation, insurance and corporate expenses.

Net loss for 2025 was $8.8 million, or $0.78 per share, compared with a net loss for 2024 of $17.5 million, or $1.72 per share.

Cocrystal reported unrestricted cash as of December 31, 2025, of $7.7 million compared with $9.9 million as of December 31, 2024. Net cash used in operating activities for 2025 was $8.2 million compared with $16.5 million for 2024. The Company had working capital of $5.9 million and 11.3 million common shares outstanding as of December 31, 2025.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2) and hepatitis C viruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create viable antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans for the future development of preclinical and clinical product candidates, the and the potential characteristics and benefits of and market for our product candidates. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from inflation, affordability, a deteriorating labor market, the possibility of recession, increases or other developments with respect to interest rates, uncertainty surrounding the impacts arising from imposed and threatened tariffs and developments with respect thereto, and wars and geopolitical conflicts including those in the Middle East and Ukraine on our Company, our collaboration partners, and on the U.S. and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors and our current and any future CROs and CMOs, the progress and results of the studies for CC-42344 and CDI-988 including issues with the initial Phase 2a study for CC-42344 which will prolong the development timeline of such product candidate, the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of future preclinical and clinical trials, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes including based on initiatives and actions taken by the Trump Administration which could, among other things, result in delays in regulatory approvals or limit access to federal funding for our programs, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, and potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
[email protected]