Category: Health

Obsidian Therapeutics Goes Public Through Galera Merger, Lands $350 Million to Fuel Cell Therapy Pipeline

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A microcap biotech is getting a new identity — and $350 million to go with it.

Galera Therapeutics (OTC: GRTX) and privately-held Obsidian Therapeutics announced today they have entered into a definitive merger agreement to combine in an all-stock transaction. The combined company will operate as Obsidian Therapeutics and plans to trade on Nasdaq under the ticker symbol OBX.

For Galera shareholders, this is a lifeline. The stock was trading at less than five cents on the OTC markets heading into this announcement. For Obsidian, it’s a calculated path to the public markets — using Galera as a vehicle to access Nasdaq without a traditional IPO.

The Deal Structure

Under the merger agreement, Galera will merge into a subsidiary of the new parent company, Gazelle Parent, Inc., while Obsidian simultaneously merges into a separate subsidiary — with both surviving as wholly owned subsidiaries of the combined parent.

Concurrent with the merger, the companies secured commitments for a private placement financing expected to generate $350 million in gross proceeds. That’s a substantial war chest for a clinical-stage biotech, and signals serious institutional conviction in Obsidian’s pipeline.

The ownership breakdown tells the real story of who’s driving this combination: pre-merger equityholders of Obsidian are expected to own approximately 53.2% of the combined company, PIPE investors approximately 45%, and Galera’s legacy shareholders approximately 1.8%. Galera’s existing stockholders are essentially getting a small equity stake in a well-funded new entity rather than facing dissolution.

Who’s Backing It

Investors in the private placement include Balyasny Asset Management, Caligan Partners, Eventide Asset Management, Nantahala Capital, Octagon Capital, Redmile, Spruce Street Capital, and Trails Edge Capital Partners. That’s a roster of credible, healthcare-focused institutional names — not speculative money.

What Obsidian Actually Does

Obsidian focuses on engineered cell and gene therapies targeting unmet medical needs, while Galera had concentrated on treatments for radiation-induced toxicities. The combined company’s primary asset is OBX-115, a TIL (tumor-infiltrating lymphocyte) cell therapy. The company expects Phase 1 NSCLC data in the first half of 2027 and topline data from a melanoma registration-enabling trial by year-end 2027, supported by the merged company’s expanded cash runway.

TIL cell therapy is an emerging but compelling approach in oncology — it extracts a patient’s own immune cells from a tumor, engineers them, and reinfuses them to fight cancer. The space has attracted significant Big Pharma attention as cell therapy continues to mature beyond CAR-T into broader tumor types.

The Bigger Picture

This transaction is a textbook example of a structure the small-cap biotech world relies on — a reverse merger into a public shell paired with a concurrent PIPE to fund the surviving entity’s operations. It avoids the cost and volatility of a traditional IPO while still achieving a Nasdaq listing and fresh capital.

Closing requires approval from Galera and Obsidian stockholders, effectiveness of a Form S-4 registration statement, receipt of the approximately $350 million in private placement proceeds, and Nasdaq approval for the new parent’s listing.

For small-cap investors, the question now is whether OBX can justify that institutional confidence when the clinical data arrives in 2027.

Release – GeoVax Positions GEO-MVA to Address Supply Constraints in Global Mpox and Smallpox Vaccine Market

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Research News and Market Data on GOVX

Highlights Critical Need for Additional MVA Vaccine Supply, Ending the Current Monopoly, Increasing Access and Supply Worldwide

ATLANTA, GA, April 14, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancer, today highlighted the urgent challenges caused by the supply-constrained, global orthopoxvirus vaccine market and outlined the strategic positioning of its GEO-MVA vaccine candidate to address the limited supply and increasing global demand.

A Procurement-Driven Market with Recurring Global Demand

The global market for vaccines targeting mpox and smallpox (orthopoxviruses) has evolved into a recurring, procurement-driven market supported by:

  • National stockpile programs across the United States, Europe and allied countries
  • Ongoing purchasing by global health organizations and regional agencies
  • Outbreak-driven surge demand tied to periodic global transmission events

Recent mpox outbreaks across multiple continents, including the emergence of more virulent strains, have reinforced the need for sustained vaccine supply beyond emergency response cycles.

Single-Supplier Market Structure and Limited Surge Capacity

The current global supply of MVA vaccines, the preferred vaccine for orthopoxvirus infections due to their recognized safety for use in vulnerable populations, is concentrated with a single commercial supplier.

This market structure has contributed to:

  • Limited surge capacity during outbreaks
  • Repeated depletion of government stockpiles
  • Increased focus on supply chain resilience and diversification

As a result, governments and public health agencies are increasingly prioritizing:

  • Establishment of additional sources of MVA vaccine supply
  • Expansion of domestic and allied manufacturing capacity
  • Reduced dependence on single-source providers for critical countermeasures

An Established Market Measured in Hundreds of Millions Annually

Public disclosures and procurement activity indicate that the mpox/smallpox vaccine market:

  • Has generated hundreds of millions of dollars in annual procurement in recent years
  • Includes multiyear purchasing frameworks and forward-looking supply agreements
  • Is supported by both baseline stockpiling demand and outbreak-driven purchasing cycles

GeoVax believes these dynamics support a durable and expanding global market, rather than a one-time, pandemic-driven market opportunity.

GEO-MVA Positioned as a Second-Source MVA Vaccine Candidate

GeoVax’s GEO-MVA vaccine candidate is being developed to address the current supply-demand imbalance. The Company believes GEO-MVA is positioned as a potential second-source MVA vaccine, with key attributes including:

  • Leverages the established MVA platform, widely used for immunocompromised and high-risk populations
  • A defined regulatory pathway, based on immuno-bridging, to an approved MVA vaccine
  • Late-stage development readiness, with Phase 3 initiation planned during 2026

GeoVax believes GEO-MVA has the potential to support:

  • National stockpile replenishment programs
  • Global outbreak response efforts
  • Long-term preparedness and biodefense strategies

Alignment with Public Health and Biodefense Priorities

The mpox/smallpox vaccine market is increasingly shaped by the intersection of:

  • Public health preparedness, driven by recurring mpox outbreaks and evolving viral threats
  • National security and biodefense priorities, including protection against biological threats

Recent U.S. and international policy initiatives have emphasized:

  • Strengthening biosecurity infrastructure
  • Expanding domestic manufacturing capabilities
  • Ensuring reliable access to critical medical countermeasures

GeoVax believes GEO-MVA is positioned for both civilian and biodefense procurement channels.

Development Timeline Synchronized with Procurement Cycles

GeoVax believes its planned development timeline for GEO-MVA corresponds with:

  • Anticipated stockpile replenishment cycles following recent depletion
  • Continued global procurement activity driven by outbreak preparedness
  • Increasing policy emphasis on supply diversification initiatives

David Dodd, Chairman and Chief Executive Officer of GeoVax, commented, “The mpox and smallpox vaccine market is not a future construct, it is an active, procurement-driven market with recurring demand and increasing strategic importance. It is also a market currently defined by supply concentration and limited surge capacity.”

Mr. Dodd added, “We believe that, if approved, GEO-MVA, which is expected to begin a pivotal Phase 3 trial this year, is positioned to enter this market as a second-source MVA vaccine at a time when governments and global health organizations are actively seeking to diversify supply and strengthen preparedness. Our focus is on executing the next phase of development and aligning GEO-MVA with procurement frameworks that support both long-term stockpiling and rapid response capabilities.”

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 – Greenwich LifeSciences Provides Update on Financing Strategy

Posted on by [email protected]

Research News and Market Data on GLSI

 Download as PDF April 14, 2026 6:00am EDT

STAFFORD, Texas, April 14, 2026 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided additional updates on its financing strategy.

The Company’s ATM financing vehicle allows the Company to sell its common stock directly into the trading market at market price. The amount raised through our ATM for Q1 2026 exceeded the Company’s Q1 2026 cash burn rate, leading to a Q1 2026 cash balance of approximately $10.5 million as of March 31, 2026. The above preliminary financial figures are unaudited and are subject to change following completion of the Company’s financial review for Q1 2026.

About FLAMINGO-01 Open Label Phase III Data

More than 1,000 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.

  • In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
  • This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
  • The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.

Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.

About GLSI-100 Phase IIb Study

In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:

  • 80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
  • The PIS elicited a potent immune response as measured by local skin tests and immunological assays.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

About Greenwich LifeSciences, Inc.

Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.

Forward-Looking Statement Disclaimer

Statements in this press release contain “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 Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.

Company Contact
Snehal Patel
Investor Relations
Office: (832) 819-3232
Email: [email protected]

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: [email protected]

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Source: Greenwich LifeSciences, Inc.

Released April 14, 2026

The Oncology Institute, Inc. (TOI) – CMS Model Shows Medicare Cost Savings, Supporting Our Investment Thesis

Posted on by [email protected]


Tuesday, April 14, 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.

TOI Methodology Continues To Improve Medicare Cost Savings. TOI announced new data from the Enhancing Oncology Model (EOM) developed by the Centers for Medicare & Medicaid Services (CMS). Data from CMS shows that during Performance Period 3, the six-month period beginning July 2024, TOI achieved cost savings of $1.8 million, equating to $6,400 per patient-episode. This compares with the Performance Period 2, from January 2024 to June 2024, in which savings were $1.1 million or $3,500 per episode.

TOI Methodology Fits Well With The EOM. The CMS Innovation Center developed the EOM as a total-cost-of-care model to improve cancer care for Medicare Fee-for-Service beneficiaries. It incentivizes oncology practices to deliver coordinated care for patients receiving chemotherapy. The EOM model has identified pharmacy, avoidable acute care, and supportive care as the three main areas for cost reduction and quality-of-care improvements. 


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Release – Cardiff Oncology Announces Key Leadership Appointments to Strengthen Executive Team for Next Phase of Growth

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Research News and Market Data on CRDF

April 9, 2026

PDF Version

Board member and Interim CEO Mani Mohindru, PhD, named President and Chief Executive Officer

Appoints industry veterans Josh Muntner as Chief Financial Officer and Ajay Aggarwal, MD, MBA, as Chief Operating Officer

SAN DIEGO, April 09, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced the appointment of Mani Mohindru, PhD, as President and Chief Executive Officer (CEO), following her time as Interim CEO, and that she will continue as a member of the Board. The Company also appointed Josh Muntner as Chief Financial Officer and Ajay Aggarwal, MD, MBA, as Chief Operating Officer, effective April 6 and April 27, respectively. Together, these appointments reflect Cardiff’s commitment to building an experienced leadership team to advance onvansertib and deliver on the program’s long-term potential.

“I am honored to step into the role of Chief Executive Officer at this important time for Cardiff. We have made meaningful progress advancing onvansertib in first-line RAS-mutant metastatic colorectal cancer and remain focused on delivering clinical data to support our registrational program,” said Mani Mohindru, PhD, President and Chief Executive Officer. “Building the right team to advance this promising asset is central to our strategy and to ultimately delivering a potential new therapy to patients in need.”

Dr. Mohindru continued, “We are excited to welcome Josh and Ajay to our team. Josh is a highly accomplished financial leader with a strong track record of executing complex financings and building trusted relationships across the investment community. Ajay brings deep clinical development and operational expertise, with a proven ability to advance programs from early research through late-stage development. Together, their complementary experience strengthens our ability to execute our strategic priorities.”

Josh Muntner

Mr. Muntner brings deep expertise in capital markets strategy, financial operations and supporting clinical-stage organizations through key inflection points. He is a seasoned biopharma finance executive with more than 25 years of experience spanning investment banking and corporate leadership roles, including as CFO of both private and publicly traded biotechnology companies. Previously, Mr. Muntner served as Chief Financial Officer of Imvax, Inc., where he led all finance functions, including raising $86 million in a convertible financing. Prior to that, he served as Chief Financial Officer of Mesoblast Ltd., a Nasdaq- and ASX-listed biotechnology company, where he completed multiple cross-border equity and debt financings totaling approximately $300 million and helped expand the company’s U.S. investor base. Earlier in his career, Mr. Muntner held senior roles in investment banking, completing more than 90 transactions and raising over $9 billion in equity and debt financing for life sciences companies. Mr. Muntner serves as a member of the Board Directors at Devonian Health Group Inc., a biopharmaceutical company developing immunomodulatory treatments for inflammatory diseases.

Mr. Muntner holds an MBA from the UCLA Anderson School of Management and a BFA from Carnegie Mellon University.

Ajay Aggarwal, MD, MBA

Dr. Aggarwal is a board-certified Pulmonary, Critical Care and Sleep Medicine physician with more than 15 years of experience in the pharmaceutical industry, spanning respiratory, immunology and oncology drug development. Most recently, he served as Senior Vice President and Head of Clinical Development at Aclaris Therapeutics, where he led clinical strategy and execution across multiple programs.

Prior to Aclaris, Dr. Aggarwal served as Chief Medical Officer of CereXis, Inc., a company advancing therapies for rare neurology and oncology indications. He has also held clinical leadership roles at Insmed, Inc. and AstraZeneca PLC, where he successfully advanced several compounds from preclinical stages into late-stage clinical development.

Earlier in his career, he held academic leadership roles, including Chief of Medicine at a VA Hospital, and has authored numerous peer-reviewed publications. He is a Fellow of the American College of Chest Physicians.

Dr. Aggarwal received his MBA from the Kellogg School of Management at Northwestern University and his medical degree from the All India Institute of Medical Sciences.

Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

In connection with Mr. Muntner joining Cardiff Oncology, the Company’s Board of Directors approved the grant of non-qualified stock options to purchase 486,650 shares of Cardiff Oncology common stock outside of the Cardiff Oncology 2021 Omnibus Equity Incentive Plan. The stock option was granted as an inducement material to Mr. Muntner becoming an employee of Cardiff Oncology in accordance with Nasdaq Listing Rule 5635(c)(4). The option was granted as of April 6, 2026, and has an exercise price of $1.58 per share, the closing price on the grant date. The option vests over four years with 25% vesting after 12 months and the remaining shares vesting monthly over the following 36 months, subject to Mr. Muntner’s continued employment with Cardiff Oncology on such vesting dates.

About Cardiff Oncology, Inc. 
Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated in a Phase 2 trial for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients. 
For more information, please visit https://www.cardiffoncology.com.

Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Cardiff Oncology’s expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances. 

Investor Contact: 
Candice Masse 
astr partners 
[email protected] 

Media Contact:  
Amy Bonanno 
Lyra Strategic Advisory 
[email protected] 

Release – MAIA Biotechnology Expects Recent $33 Million Capital Raise to Fully Fund Ongoing Pivotal Phase 3 Trial of Novel Telomere-Targeting Anticancer Therapy

Posted on by [email protected]

Research News and Market Data on MAIA

April 08, 2026 9:00am EDT Download as PDF

Strong participation in recent $33 million common stock offering highlights investor confidence in late-stage clinical momentum and commercial potential

Statistical assessments point to high probability of technical success
in Phase 3 full approval trial

FDA granted Fast Track designation for dual mechanism therapy as a treatment for non-small cell lung cancer (NSCLC)

CHICAGO, April 08, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that net proceeds from its $33 million public offering of common stock in March 2026 are expected to fully fund the Company’s ongoing pivotal Phase 3 clinical trial of its lead investigational therapy, ateganosine, as a treatment for non-small cell lung cancer (NSCLC). Ateganosine is a dual mechanism therapy designed to break down telomere structure and function in cancer cells while inducing immune activation. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the drug in third line (3L) NSCLC treatment.

“We are grateful for the support and confidence shown by the healthcare-dedicated investors and existing shareholders who participated in our recent offering. The $33 million raise is expected to complete the necessary funding for our pivotal Phase 3 trial through completion,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA

“Statistical assessments point to a high probability of technical success in the third-line setting if Phase 3 data is consistent with our Phase 2 trial results,” Dr. Vitoc continued. “Interim data from the Phase 3 trial, expected next year, may support a discussion with the FDA to present our case for early full commercial approval in third-line NSCLC.”

MAIA’s pivotal Phase 3 trial, THIO-104, evaluates the efficacy of ateganosine administered in sequence with a checkpoint inhibitor (CPI) in third-line NSCLC patients who are resistant to checkpoint inhibitors alone and chemotherapy. The global multicenter, open-label, pivotal Phase 3 trial is designed to provide a direct comparison to chemotherapy in a 1:1 randomization of up to 300 patients. Chemotherapy is the standard utilized treatment for third-line NSCLC patients.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-104 Phase 3 Clinical Trial

THIO-104 is a multicenter, open-label, randomized Phase 3 clinical trial, designed to evaluate ateganosine’s telomere-targeting anti-tumor activity when followed by PD-(L)1 inhibition in patients with advanced third-line NSCLC who previously did not respond or developed resistance to treatment regimens containing checkpoint inhibitor and/or chemotherapy and have progressed. The trial has two primary objectives: (1) to assess the clinical efficacy of ateganosine compared to investigator’s choice of chemotherapy, using median Overall Survival (OS) as the primary clinical endpoint (2) to evaluate the safety and tolerability of ateganosine in sequential combination with a checkpoint inhibitor. For more information on this Phase 3 trial, please visit ClinicalTrials.gov using the identifier NCT06908304.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates and (viii) the funding status for our Phase 3 trial for ateganosine, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
[email protected]

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Source: MAIA Biotechnology, Inc.

Released April 8, 2026

Greenwich LifeSciences, Inc. (GLSI) – New Claims Filed To Expand Patent Estate Covering GP2

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.

New Data Added To Expand Patent Claims. Greenwich LifeSciences announced that it has filed new patent claims to expand the patent estate covering GP2, the proprietary compound in GLSI-100. The new claims add recently announced data from the Phase 3 FLAMINGO-01 trial that show the immune response and recurrence rate for non-HLA*02 patients. These claims could expand both the scope and the term of the patent estate beyond previous claims from HLA*02 patients.

Broadening Patent Protection Protects Against Competitors. Patent claims covering the immune response that results from GLSI-100 treatment could help lock out competitors trying to develop similar compounds. If a new compound were able to avoid patents covering GP2, it would be blocked by the new claims covering the immune response that follows.


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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. 

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.


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. 

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

Posted on by [email protected]

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.

Logo: https://mma.prnewswire.com/media/1707291/NeuroSense_Therapeutics_Logo.jpg

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

Posted on by [email protected]

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

Posted on by [email protected]

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

PDF Version

  • 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]