Category: Health

Release – PrimeC New Data to Be Presented at AD/PD™ 2026 Conference

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Research News and Market Data on NRSN

Dr. Christian Lunetta to Present “From PARADIGM to PARAGON: Advancing PrimeC for ALS through Phase 2 Clinical and Biomarker Insights toward a Global Phase 3 Trial”

CAMBRIDGE, Mass., March 18, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced that Dr. Christian Lunetta will present new data and insights on the development of PrimeC, the company’s investigational therapy for amyotrophic lateral sclerosis (ALS), at the AD/PD™ 2026 International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders, to be held in Copenhagen, Denmark, on March 19, 2026.

Dr. Lunetta’s presentation, titled “From PARADIGM to PARAGON: Advancing PrimeC for ALS through Phase 2 Clinical and Biomarker Insights toward a Global Phase 3 Trial,” will take place during the symposium “Mechanisms and Therapeutics in the ALS-FTD Spectrum (SOD-1, TDP-43, C9ORF72 and TMEM106B).”

The presentation will review key clinical and biomarker findings from the Phase 2b PARADIGM trial, which evaluated PrimeC in people living with ALS. The data provide important insights into disease mechanisms and treatment effects that helped inform the design of the company’s global Phase 3 PARAGON trial, currently being advanced to further evaluate PrimeC’s safety and efficacy.

“ALS is one of the most complex neurodegenerative diseases, and advancing therapeutic development requires the integration of rigorous clinical research with deeper biological insight,” said Dr. Christian Lunetta. “The clinical findings emerging from the PARADIGM trial, together with the expanding biomarker analyses, provide an important scientific foundation as we advance toward the PARAGON Phase 3 study. I look forward to sharing these results with the scientific community at AD/PD 2026 and to contributing, together with fellow investigators, to the next stage of clinical development as we work to advance meaningful therapeutic options for people living with ALS.”

“We are deeply appreciative of Dr. Lunetta’s role in presenting these findings and of his contribution as part of the clinical investigator community behind this work,” said Dr. Shiran Zimri, NeuroSense VP of Research and Development and Canada Country Lead. “The timing of this presentation, coming just days after the publication of the PARADIGM results in JAMA Neurology and at such a highly regarded scientific forum, is especially meaningful. It creates a unique moment where robust, peer-reviewed data can immediately be brought into scientific exchange and critical discussion. For us, this is not only about sharing results, but about engaging the field in a deeper understanding of the clinical and biomarker insights from PARADIGM as we advance with urgency toward our global Phase 3 PARAGON study.”

The PARAGON Phase 3 trial is planned as a multinational, randomized, double-blind, placebo-controlled study designed to further evaluate PrimeC’s potential to slow disease progression in people living with ALS.

NeuroSense continues active engagement with regulatory authorities to advance PrimeC toward potential marketing authorization.

About NeuroSense

NeuroSense Therapeutics 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.

About PrimeC

PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS and AD.

About ALS

Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

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, meetings and regulatory decisions. Further, certain forward-looking statements, including statements regarding future development of PrimeC, 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 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 April 7, 2025 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: [email protected] | Tel: +972 (0)9 799 6183

Release – Greenwich LifeSciences Provides Update on Upcoming AACR Meeting

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Research News and Market Data on GLSI

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March 18, 2026 6:00am EDT

STAFFORD, Texas, March 18, 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 an update on the upcoming AACR Meeting 2026.

Two abstracts and two posters were accepted for presentation. The titles and authors of the abstracts are as follows:

Abstract Number: CT138 – Poster Section 52 on April 20, 2026, 2-5pm

Abstract Title: Preliminary delayed-type-hypersensitivity immune response results from open-label arm of on-going Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy, Flamingo-01

Snehal S. Patel1, Jaye Thompson1, F. Joseph Daugherty1, Francois-Clement Bidard2, William J. Gradishar3, Marcus Schmidt4, Miguel Martin5, Joyce A. O’Shaughnessy6, Hope S. Rugo7, Cesar A. Santa-Maria8, Laura M. Spring9, Mothaffar F. Rimawi10

1Greenwich LifeSciences, Stafford, TX,2Institut Curie, Paris, France,3Northwestern University, Chicago, IL,4University Medical Center Mainz, Mainz, Germany,5GEICAM, Madrid, Spain,6Sarah Cannon Research Institute, Dallas, TX,7City of Hope Comprehensive Cancer Center, Duarte, CA,8Johns Hopkins University, Baltimore, MD,9Massachusetts General Hospital, Boston, MA,10Lester and Sue Smith Breast Center, Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX

  • This will be the first abstract and poster from FLAMINGO-01 with statistically significant immune response data, potentially with subgroup analysis by the most prevalent HLA types. A positive immune response is an indicator that the immune system has been activated against recurring cancer cells, potentially leading to the prevention of metastatic breast cancer and improved long term survival.
  • Immune responses to GP2 were measured at baseline and over time using delayed-type-hypersensitivity (DTH) skin tests and other methods. The DTH skin test measures the diameter of the skin immune response to GP2 in millimeters, 48-72 hours after intradermal injection of a low concentration of GP2 without GM-CSF.

Abstract Number: CT227 – Poster Section 51 on April 21, 2026, 9am-12pm

Abstract Title: Phase III study to evaluate the efficacy and safety of GLSI-100 (GP2 + GM-CSF) in breast cancer patients with residual disease or high-risk PCR after both neo-adjuvant and postoperative adjuvant anti-HER2 therapy, Flamingo-01

Jaye Thompson1, Snehal Patel1, Mira Patel1, Anu Tammareddi1, F. Joseph Daugherty1, Mothaffar F. Rimawi2

1Greenwich LifeSciences, Stafford, TX,2Lester and Sue Smith Breast Center, Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX

  • This abstract and poster will continue to update principal investigators at the conference about the study design of FLAMINGO-01.

The Steering Committee authoring abstract CT138 is comprised of the following experts in the field of breast cancer oncology representing prominent teaching hospitals in the US and 4 of the largest breast oncology networks in the US, Germany, France, and Spain:

  • Dr. Mothaffar F. Rimawi – Professor of Medicine at the Baylor College of Medicine and Executive Medical Director and Co-Leader, Breast Cancer Program of the Dan L Duncan Comprehensive Cancer Center
  • Dr. Francois-Clement Bidard – Professor of Medical Oncology, UVSQ/Paris Saclay University, Head of Breast Cancer Group, Institut Curie, Vice-Chair of the French Breast Cancer research group UCBG (Unicancer)
  • Dr. William J. Gradishar – Professor of Medicine at the Feinberg School of Medicine at Northwestern University, Chief of Hematology and Oncology in the Department of Medicine, and Betsy Bramsen Professor of Breast Oncology
  • Dr. Sibylle Loibl – Professor (apl) Goethe University Frankfurt/M, Clinical Consultant Centre for Haematology and Oncology/Bethanien Frankfurt/M, CEO of GBG Forschungs GmbH & Chair of the German Breast Group (GBG)
  • Dr. Miguel Martin – Professor of Medicine, Head, Medical Oncology Service, Gregorio Marañón General University Hospital, Complutense University, Madrid, CEO of GEICAM
  • Dr. Joyce A. O’Shaughnessy – Celebrating Women Chair in Breast Cancer, Baylor University Medical Center and Chair, Breast Cancer Program, Texas Oncology, US Oncology, Dallas, Texas
  • Dr. Hope S. Rugo – Director, Women’s Cancers Program, Division Chief, Breast Medical Oncology, Professor, Department of Medical Oncology & Therapeutics Research, City of Hope Comprehensive Cancer Center, Professor Emeritus, University of California, San Francisco
  • Dr. Cesar A. Santa-Maria – Associate Professor of Oncology, Breast and Gynecological Malignancies Group, Director of Breast Cancer Trials, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
  • Dr. Laura M. Spring – Assistant Professor, Medicine, Harvard Medical School, Attending Physician, Medical Oncology, Massachusetts General Hospital

About the AACR Annual Meeting 2026

The AACR is the first and largest cancer research organization dedicated to accelerating the conquest of cancer and has more than 61,000 members residing in 143 countries and territories. The AACR Annual Meeting is the focal point of the cancer research community, where scientists, clinicians, other health care professionals, survivors, patients, and advocates gather to share the latest advances in cancer science and medicine. From population science and prevention; to cancer biology, translational, and clinical studies; to survivorship and advocacy; the AACR Annual Meeting highlights the work of the best minds in cancer research from institutions all over the world.

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 March 18, 2026

Gyre Therapeutics, Inc (GYRE) – Priority Review Received For Hydronidone In China

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Wednesday, March 18, 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.

Gyre Receives Priority Review. Hydronidone has been awarded Priority Review Status by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). This is consistent with our expectations for an accelerated NDA review and late FY2026 approval for Hydronidone.

Meeting With The CMPA Was Positive. In early January, Gyre Pharmaceuticals (China) held a Pre-New Drug Application meeting with the CDE. At that time, the CDE agreed that data from the Hydronidone Phase 3 trial for treating chronic hepatitis B (CHB)-associated liver-fibrosis supported an application for conditional approval. It also met the criteria for Priority Review.


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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. 

Greenwich LifeSciences, Inc. (GLSI) – Preliminary Phase 3 FLAMINGO-01 Update Shows Reduction In Breast Cancer Recurrence Rate

Posted on by [email protected]


Wednesday, March 18, 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 Analysis Shows Less Than 1% Recurrance Rate. Greenwich Pharmaceuticals announced a preliminary update from its FLAMINGO-01 trial. The data from the open-label arm of the trial showed a recurrence rate of less than 1% per year compared to a recurrence rate of 4% per year for patients treated with Kadcyla (ado-trastuzumab emtansine or T-DM1, from Genentech) in the Phase 3 KATHERINE Study. This is a 70% to 80% reduction in the historical recurrence rate for these patients.

Background On The Phase 3 FLAMINGO-01 Trial. The trial tests GLSI-100, an immunotherapy to prevent recurrence of  HER2-positive breast cancer. Its design has a double-blind portion that enrolls patients with the immune marker HLA-A*02 to receive either GLSI-100 or placebo, and an open-label arm that enrolls patients that have other HLA types (non-HLA-A*02). The new data is from the open-label arm of the trial.


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 – Tonix Pharmaceuticals Announces Oral Presentation and Two Poster Presentations on Preclinical Immuno-oncology Portfolio at the American Association for Cancer Research (AACR) Annual Meeting 2026

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Research News and Market Data on TNXP

March 17, 2026 4:35pm EDTDownload as PDF

BERKELEY HEIGHTS, N.J., March 17, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, today announced an oral presentation and two poster presentations on its preclinical immuno-oncology portfolio at the American Association for Cancer Research (AACR) Annual Meeting 2026, being held April 17–22, 2026, in San Diego, California.

Oral Presentation Details

Title: TFF2 deficiency amplifies IL-1β-driven inflammation and promotes aging-associated gastric tumor progression
Abstract #: 6822
Date and Time: April 21, 2026, 2:30–4:30 p.m. PT (5:30-7:30 p.m. ET)
Session Category: Tumor Biology
Session Title: Aging Micro- and Macro-Environments in Tumor Progression and Therapy
Presenters: Shuang Li, MD, PhD, and Timothy C. Wang, MD, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center (Tonix co-authors: Seth Lederman, MD, Chief Executive Officer, and Bruce L. Daugherty, PhD, MBA, Executive Vice President of Research)

Poster Presentation Details

Title: In vitro characterization of fully human antagonistic anti-BTLA monoclonal antibodies
Poster #: 6550
Date and Time: April 21, 2026, 2:00-5:00 p.m. PT (5:00-8:00 p.m. ET)
Session Category: Clinical Research
Session Title: Immune Checkpoint Blockade
Location: Poster Section 44, Board 16
Presenter: Bruce Daugherty, PhD, MBA, Executive Vice President of Research, Tonix

Title: Pharmacokinetics of TNX-1700 in non-human primates and human FcRn/serum albumin transgenic mice
Poster #: 7940
Date and Time: April 22, 2026, 9:00 a.m.–12:00 p.m. PT (12:00-3:00 p.m. ET)
Session Category: Clinical Research
Session Title: Tumor Microenvironment Modulators
Location: Poster Section 49, Board 15
Presenter: Bruce Daugherty, PhD, MBA, Executive Vice President of Research, Tonix

Copies of the Company’s presentations will be available under the Scientific Presentations tab on the Tonix website at www.tonixpharma.com.

About TNX-1700
TNX-1700, a fusion protein of TFF2 and albumin, is in preclinical development for the treatment of gastric and colorectal cancer in combination with PD-1 blockade. TNX-1700, in-licensed from Columbia University, is in the pre-Investigational New Drug (IND) stages of development.

Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals* is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg), is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. In addition, the company’s CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X.

*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a trademark of Tonix Pharma Limited. All other marks are property of their respective owners.

Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially as a result of a number of factors, including the ability of the Company to satisfy the conditions to the closing of the offering and the timing thereof, as well as those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contacts
Jessica Morris
Tonix Pharmaceuticals
[email protected]
(862) 799-8599

Brian Korb
astr partners
(917) 653-5122
[email protected]  

Media Contacts
Deborah Elson
Tonix Pharmaceuticals 
[email protected]

Ray Jordan
Putnam Insights
[email protected]  

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Source: Tonix Pharmaceuticals Holding Corp.

Released March 17, 2026

Release – Gyre Therapeutics Announces China’s NMPA Grants Priority Review to the NDA for Hydronidone (F351) for CHB-Induced Liver Fibrosis Treatment

Posted on by [email protected]

Research News and Market Data on GYRE

March 17, 2026

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SAN DIEGO, March 17, 2026 (GLOBE NEWSWIRE) — Gyre Therapeutics, Inc. (Gyre or Gyre Therapeutics) (Nasdaq: GYRE), a San Diego-based innovative commercial stage biopharmaceutical company with operations in the United States and China, today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) for Hydronidone (F351) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus (HBV). This decision by CDE was made following the pre-NDA communication meeting previously announced on January 5, 2026 and is a major milestone in the NDA process. Gyre, through its majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals), plans to submit a formal NDA in the near future.

Mr. Ping Zhang, Executive Chairman of Gyre, stated, “I am very pleased to see the decision by the Chinese CDE to grant priority review to our NDA for F351. It underscores both the urgency of the medical need to treat liver fibrosis and the potential of F351 as an innovative therapeutic option. HBV infection affects tens of millions of patients in China and a significant number of them will develop liver fibrosis and eventually cirrhosis. If approved, F351 could address the need for these patients. We thank the agency for their continued support to advance therapies for liver fibrosis patients in need of treatment and look forward to working closely with CDE to move F351 toward approval.”

About Priority Review Designation by the NMPA in China

Priority review was established in China in 2017 to facilitate drug registration and accelerate the development of new drugs with clinical value under the guidance of Opinions on Encouraging Pharmaceutical Innovation via Priority Review & Approval. According to these guidelines, the NMPA will prioritize the review of these applications and allocate additional evaluation resources, which is expected to accelerate the review process.

About Hydronidone (F351)

Hydronidone, also known as F351, is a novel, orally administered anti-fibrotic agent designed to target key liver fibrosis pathways. It attenuates hepatic stellate cell activation and fibrogenesis, at least in part, by suppressing TGF-β1-induced signal transduction, including reduced p38γ phosphorylation and upregulated Smad7 expression. This upregulation of Smad7 subsequently leads to downregulation of TGF-βRI and inhibition of Smad2/3 activation, thereby disrupting canonical TGF-β/Smad signaling and reducing fibrotic gene expression in HSCs.

The drug has completed Phase 3 clinical evaluation in China for CHB-associated liver fibrosis, including early (compensated) cirrhosis, and is being evaluated for its potential applicability across additional fibrotic diseases in region-specific development programs.

About CHB-Induced Liver Fibrosis

CHB-induced liver fibrosis is the accumulation of scar tissue (collagen) in the liver caused by persistent inflammation from hepatitis B virus. According to the World Health Organization, approximately 254 million people worldwide were living with CHB infection in 2022, with 1.2 million new infections each year, and 1.3 million deaths globally. CHB is the leading aetiology of liver fibrosis and liver cancer globally, with up to 36% of all CHB patients globally developing cirrhosis. CHB prevalence varies across geographies with China and the United States estimated to have among the highest number of CHB cases.

About Gyre Pharmaceuticals

Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.8 million). In addition, Gyre Pharmaceuticals’ pipeline includes Hydronidone, a structural analogue of pirfenidone, which demonstrated statistically significant fibrosis regression after 52 weeks of treatment in a pivotal Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC. Hydronidone received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, RILI with or without immune-related pneumonitis, COPD, PAH and ALF/ACLF. As of the third quarter of 2025, Gyre Therapeutics owns a 69.7% equity interest in Gyre Pharmaceuticals.

About Gyre Therapeutics

Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis including MASH in the U.S. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the PRC, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230. On March 2, 2026 Gyre announced its agreement to acquire Cullgen Inc., a privately-held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degraders and degrader antibody conjugate therapies.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts and the timing of expected clinical readouts and regulatory filings, including the anticipated timing of the filing of Gyre’s NDA with the NMPA for the conditional approval of Hydronidone for the treatment of CHB-associated liver fibrosis and early cirrhosis and the initiation of the confirmatory Phase 3c clinical trial of Hydronidone to support full approval in China. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital; supply chain and distribution delays and challenges. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2025 filed on March 13, 2026 and in other filings with the Securities and Exchange Commission.

Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

Contact:

Ping Zhang, interim CEO and Executive Chairman

[email protected]

Release – Greenwich LifeSciences Provides Update Showing Continued Reduction in Recurrence Rate in the Open Label Arm of FLAMINGO-01

Posted on by [email protected]

Research News and Market Data on GLSI

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March 17, 2026 6:00am EDT

STAFFORD, Texas, March 17, 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 GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided a preliminary update showing a continued reduction in the recurrence rate in the fully enrolled, 250 patient, open label non-HLA-A*02 arm of FLAMINGO-01.

  • 6 Months of Additional Patient Data Since Last Update Shows Recurrence Rate of <1% per Year in Non-HLA-A*02 Patients Treated with GLSI-100, Following Completion of Primary Immunization Series (PIS)
  • This <1% Annual Recurrence Rate Observed in Non-HLA-A*02 Patients is Statistically Significantly Smaller Than a 4% Annual Recurrence Rate Over a Similar Time Period Observed in the Katherine Study (Kadcyla Treated Arm) Yielding an Approximately 70-80% Reduction in Recurrence Rate as Explained Below

The non-HLA-A*02 arm does not have a direct placebo comparator arm, thus a Kaplan Meier survival analysis is not possible, and the following method was used:

  • The <1% recurrence rate per year of these 250 treated patients after completing the PIS was compared to the expected historical recurrence rate per year reported for a similar population in the Katherine study who received TDM1 (Kadcyla), which is about 4% recurrences per year or higher in the initial years of the Katherine study. The majority of the treated patients in FLAMINGO-01 also received TDM1 followed by GLSI-100.
  • As of this data cut, the current recurrence rate of the non-HLA-A*02 patients treated with GLSI-100, following completion of the PIS over an average of 1.2 years of patient exposure, is statistically significantly smaller than a 4% annual recurrence rate over a similar time period observed in the Katherine study (0.7% versus 4% annual recurrence rate over 1.2 patient-years, 83% reduction in recurrence rate, Chi Square, p < 0.005). This preliminary data will continue to be updated and cleaned, so future and final results may vary. Future updates may be presented at upcoming conferences.
  • 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.

Additional information about the non-HLA-A*02 arm follows:

  • Virtually all of the non-HLA-A*02 patients have completed the primary immunization series, which is the first 6 monthly vaccinations in the study.
  • Every 6 months approximately 110 patient-years are added to the non-HLA-A*02 patient data base.
  • Enhertu (T-DXd) treated patients can be enrolled in FLAMINGO-01. In the future, if Enhertu is approved for high risk patients in the adjuvant setting, more Enhertu treated patients could be enrolled in FLAMINGO-01 and may recur at a lower rate than if treated with Kadcyla. The recurrence rate assumptions in the design of FLAMINGO-01 include this possibility as well as other potential improvements in standard of care.

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 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 compared to the recurrence rates comparable to those observed in the Katherine study of Kadcyla shows an approximately 70-80% reduction in recurrence rate.
  • This non-HLA-A*02 arm 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 March 17, 2026

NeuroSense Therapeutics Ltd. (NRSN) – Phase 2b PARADIGM Study Published In JAMA Neurology

Posted on by [email protected]


Tuesday, March 17, 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.

Presigious Journal Publishes The Phase 2b PARDIGM Study. JAMA Neurology has published an article dissussing the Phase 2b PARDIGM clinical trial. This peer-reviewed journal is published by the American Medical Association and regarded as one of the most prestigious journals in the field of neurology. We see this as a validation the clinical results and an acknowledgement of the impact PrimeC had on the amyotrophic lateral sclerosis (ALS) patients in the study.

PrimeC Addresses Important Mechanisms Of Neuron Degeneration. PrimeC is a proprietary fixed-dose oral combination of celecoxib and ciprofloxacin. These drugs target pathways of neuronal cell death, including regulation of microRNA synthesis, reduction in neuroinflammation, and modulation of iron accumulation. Additional testing by NeuroSense determined the optimal dosage combination of the two drugs for human studies and the extended releaase formulaton.


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Big Pharma Is Running Out of Time — And Small-Cap Biotechs Are the Answer

Posted on by [email protected]

The pharmaceutical industry is facing a revenue crisis of its own making, and the fallout is quietly creating one of the most compelling acquisition environments for small-cap biotech investors in recent memory. The catalyst is straightforward: patent expirations on some of the world’s best-selling drugs are set to eliminate hundreds of billions in annual revenue from major drugmakers’ balance sheets, and the only viable path to replacing that income runs directly through the small-cap biotech sector.

An estimated $236 billion in annual Big Pharma revenue is at risk as blockbuster drugs lose exclusivity in the 2026–2030 window. Flagship products from AbbVie, Merck, Bristol Myers Squibb, and Pfizer are all exposed. Pfizer alone faces a revenue shortfall that analysts project could reach $17–18 billion by 2030 as key drugs lose patent protection. These are not minor headwinds — they represent structural holes in revenue models that took decades to build.

Acquisition Is the Only Realistic Fix

Internal R&D pipelines, no matter how well-funded, cannot reliably produce late-stage, de-risked assets fast enough to offset losses of this scale. That reality is driving an acceleration of M&A activity at a pace not seen in years. Biopharma dealmaking surged to $43.2 billion in value in Q3 2025 alone — a 36.7% jump quarter-over-quarter — and analysts broadly expect 2026 and 2027 to see even more aggressive activity as patent deadlines loom closer.

The targets of choice are small-cap biotechs with proven or near-proven assets, particularly those with late-stage clinical data in high-value therapeutic areas like oncology, rare disease, and immunology. These companies represent an increasingly attractive proposition: they carry significantly lower valuation multiples than large-cap pharma — many trading around 6x revenue — while offering precisely the pipeline depth that major acquirers need most.

What This Means for Small-Cap Investors

For investors paying attention to the small and microcap biotech space, this dynamic creates a clear opportunity structure. Companies advancing late-stage assets in therapeutic categories where major drug patents are expiring are sitting at the intersection of scientific value and urgent corporate need. That combination has historically produced acquisition premiums that significantly reward early investors.

Novartis’s $12 billion acquisition of Avidity Biosciences stands as one of the most cited recent examples — a deal that illustrated how quickly a credible pipeline can attract top-tier buyers willing to pay a substantial premium. It will not be the last. With private equity also sitting on an estimated $440 billion in dry powder earmarked for smaller enterprises, competition for the highest-quality small-cap biotech targets is intensifying from both strategic and financial buyers simultaneously.

The Floor Has Shifted

What makes this M&A wave structurally different from prior cycles is the urgency driving it. This is not opportunistic dealmaking — it is defensive necessity for some of the most capitalized companies in the world. That urgency creates a pricing floor for quality small-cap biotech assets that did not exist five years ago.

For investors willing to do the fundamental work of identifying companies with credible late-stage pipelines, strong IP positions, and exposure to the therapeutic categories where patent cliffs are most acute, the current environment may represent one of the better entry windows of the decade. The deals are coming. The question is whether investors are positioned ahead of them.

Release – JAMA Neurology Publishes Results from PARADIGM Phase 2b Trial of PrimeC in ALS Demonstrating Meaningful Clinical Outcomes and Biological Activity

Posted on by [email protected]

Research News and Market Data on NRSN

The Journal of the American Medical Association (JAMA Neurology) publication highlights consistent clinical and biomarker findings from NeuroSense PARADIGM Phase 2b trial in ALS, including slower functional decline, reduced risk of ALS-related complications, and modulation of disease-relevant biomarkers

CAMBRIDGE, Mass., March 16, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced that results from the Phase 2b clinical trial (PARADIGM) evaluating PrimeC in people living with amyotrophic lateral sclerosis (ALS) have been published in JAMA Neurology.

Continue Reading

Earlier today, Mass General Brigham (MGB) and Barrow Neurological Institute (BNI) issued a joint announcement highlighting the publication and the contributions of the investigators involved in the PARADIGM trial. NeuroSense is honored to collaborate with these leading ALS research centers of excellence and their distinguished clinical teams in advancing research for people living with ALS.

PARADIGM was a randomized, double-blind, placebo-controlled trial that evaluated the safety, biological activity, and potential clinical effects of PrimeC during a 6-month blinded treatment period followed by a 12-month open-label extension.

PrimeC is a novel fixed-dose oral combination formulated in a synchronized extended-release composition designed to concurrently address three key mechanisms implicated in ALS progression: neuroinflammation, iron dysregulation, and microRNA-mediated regulatory pathways.

The publication was authored by a distinguished international group of ALS investigators, including Merit Cudkowicz, MD, MSc (Mass General Brigham and Harvard Medical School), Vivian Drory, MD (Tel-Aviv Sourasky Medical Centre), Adriano Chiò, MD, PhD (University of Torino), Christian Lunetta, MD (IRCCS Maugeri), Christen Shoesmith, MD (London Health Sciences Centre), Ruben van Eijk, MD, PhD (UMC Utrecht), Jeffrey Rosenfeld, MD, PhD (Loma Linda University), and Jeremy Shefner, MD, PhD (Barrow Neurological Institute), together with additional collaborators across North America, Europe, and Israel.

Key highlights from the PARADIGM phase 2b study published

  • Strong safety and tolerability profile: PrimeC demonstrated a safety profile comparable to placebo over 18 months, with most treatment-related adverse events mild to moderate and transient.
  • Clinically meaningful functional outcomes: Continuous treatment with PrimeC was associated with slower functional decline and improved long-term outcomes, including a 7.92-point advantage in ALSFRS-R at 18 months, which represents over 36% benefit of slowing disease progression (p=0.007) and significant improvement in bulbar function (P=0.001).
  • Reduction in risk of major ALS complications: Early initiation of PrimeC was associated with a 64% relative reduction in risk of ALS-related complications (p=0.02), including respiratory failure, hospitalization, or death.
  • Biological evidence supporting disease modification: PrimeC treatment was associated with significant modulation of ALS-related microRNAs and iron-regulatory biomarkers, supporting its biological activity and reinforcing the potential for disease-modifying effects.
  • Supports advancement to Phase 3: These findings support the continued clinical development of PrimeC and its advancement to a confirmatory Phase 3 clinical trial in ALS.

“ALS is one of the most serious neurological diseases, and there is an urgent need for therapies that can meaningfully alter its course,” said Merit Cudkowicz, MD, MSc, Director of the Healey & AMG Center for ALS at Mass General Brigham and Julieanne Dorn Professor of Neurology at Harvard Medical School. “What is particularly noteworthy about the PARADIGM results is the consistency of the findings across clinical outcomes and disease-relevant biomarkers, in addition to good safety. These results provide a strong scientific rationale for continuing the clinical development of PrimeC and support its evaluation in a larger confirmatory Phase 3 trial.”

“What stands out about the PARADIGM study is the multiple clinical endpoints suggest the same level of clinical benefit and that multiple biomarkers are consistent with clinical endpoints,” said Jeremy M. Shefner, MD, PhD, Professor of Neurology at the Barrow Neurological Institute and corresponding author of the publication. “Together, these findings provide a strong scientific foundation for advancing PrimeC into a Phase 3 trial designed to validate its impact for patients.”

“The publication of the PARADIGM results in the prestigious JAMA Neurology represents an important milestone for NeuroSense and for people living with ALS,” said Ferenc Tracik, MD, Chief Medical Officer of NeuroSense Therapeutics. “This article integrates PrimeC’s safety, clinical, and biomarker data over 18 months. The consistent findings of slower functional decline, reduced risk of ALS-related complications, and modulation of iron-regulatory and microRNA biomarkers strengthen confidence in PrimeC’s potential as a disease-modifying therapy. These findings directly informed the design of our Phase 3 trial, which has received FDA clearance to proceed.”

PARADIGM Study Overview

PARADIGM was a multinational Phase 2b randomized, double-blind, placebo-controlled clinical trial conducted at leading ALS referral centers in Italy, Canada, and Israel.

The study enrolled 68 participants with definite or probable ALS, randomized in a 2:1 ratio to receive PrimeC or placebo for six months. The double-blind phase was followed by a 12-month open-label extension, during which all participants received PrimeC while maintaining blinding to original treatment assignment.

Even though the trial was not powered to demonstrate definitive efficacy, participants who received PrimeC from the outset maintained a clinically meaningful 7.92-point functional advantage in ALSFRS-R at 18 months, which represents over 36% benefit of slowing disease progression (p=0.007), with the largest improvement observed in the bulbar domain (p=0.001), a key determinant of speech, swallowing, and quality of life in ALS.

In addition, ALS complication-free survival demonstrated a 64% relative risk reduction favoring early treatment (p=0.02), suggesting potential long-term clinical benefit.

Biomarker Findings

The trial also demonstrated biological activity consistent with PrimeC’s proposed multi-pathway mechanism.

Markers of iron metabolism, which are frequently dysregulated in ALS, showed favorable significant changes, including preservation of transferrin levels and stabilization of ferritin.

In parallel, plasma microRNA analysis revealed statistically significant downregulation of ALS-associated microRNAs miR-199a-3p, miR-199a-5p, miR-181a-5p, and miR-181b-5p, which have been linked to disease severity and prognosis.

Together, these findings provide biological evidence that PrimeC engages disease-relevant pathways and support its continued development as a potential disease-modifying therapy.

About PrimeC

PrimeC is an investigational fixed-dose oral combination therapy composed of celecoxib and ciprofloxacin in a synchronized extended-release formulation. The therapy is designed to simultaneously target multiple biological mechanisms implicated in ALS progression, including neuroinflammation, iron dysregulation, and microRNA dysregulation.

The therapeutic rationale for PrimeC is supported by preclinical evidence across ALS disease models and human induced pluripotent stem cell–derived motor neuron systems and has now been evaluated in a randomized Phase 2b clinical trial.

About NeuroSense Therapeutics

NeuroSense Therapeutics is a clinical-stage biopharmaceutical company focused on developing disease-modifying therapies for people living with ALS and other neurodegenerative diseases. The company’s lead program, PrimeC, is designed to simultaneously target multiple biological pathways implicated in ALS progression.

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, meetings and regulatory decisions. Further, certain forward-looking statements, including statements regarding future development of PrimeC, 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 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 April 7, 2025 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: [email protected] | Tel: +972 (0)9 799 6183

Release – Eledon Announces Updated Data from Investigator-Initiated Islet Transplant Trial of Tegoprubart in Patients with Type 1 Diabetes at UChicago Medicine

Posted on by [email protected]

Research News and Market Data on ELDN

March 16, 2026

PDF Version

– 12-patient cohort fully enrolled with an average time since transplant of approximately 8 months

– 100% insulin independence achieved in 10 patients who are over 4 weeks post-transplant

– No signs of graft rejection or de novo donor-specific HLA antibodies

– Tegoprubart continues to demonstrate a favorable safety and tolerability profile

IRVINE, Calif, March 16, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced updated results from an investigator-initiated trial conducted at the University of Chicago Medicine Transplant Institute and presented by Piotr Witkowski, M.D., Ph.D., Director of the Pancreas and Islet Transplant Program at UChicago Medicine, at the Advanced Technologies and Treatments for Diabetes (ATTD) conference, held March 11-14, 2026 in Barcelona, Spain.

The investigator-initiated pilot study enrolled 12 adults with long-standing type 1 diabetes undergoing allogeneic islet transplantation at UChicago Medicine. Patients had a median duration of diabetes of approximately 33 years and mean hemoglobin A1C (“HbA1C”) of approximately 8.0% prior to transplantation. Participants received tegoprubart, Eledon’s anti-CD40L monoclonal antibody, as part of a calcineurin inhibitor-free immunosuppression regimen.

The data demonstrated rapid improvement in glycemic control following islet transplantation, with stable islet graft function observed across the cohort. All 10 patients who were more than four weeks post-transplant achieved both insulin independence and a most recent HbA1c below 6.0%, with a mean most recent HbA1c across the 10 patients of approximately 5.35%. Tegoprubart-based immunosuppression was generally well tolerated with reported post-transplant immunosuppression-related adverse events successfully treated by lowering the mycophenolic acid dose, if necessary. There were no rejection episodes, and no patients developed de novo donor-specific HLA antibodies. Additionally, no evidence of nephrotoxicity, hypertension or neurotoxicity, which are commonly associated with tacrolimus-based immunosuppression regimens, was observed. These findings further support the potential of CD40L blockade to enable effective islet graft protection while avoiding the toxicities of calcineurin inhibitors.

“T1D patients have been waiting decades for a potential functional cure, and it is very encouraging to see meaningful progress in that direction through the emerging promise of tegoprubart,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “These latest findings support the potential of tegoprubart to enable effective islet graft protection while avoiding the toxicities often associated with calcineurin inhibitors, and potentially enable access to islet cell transplantation for individuals living with T1D. We are proud to contribute to these important ongoing research efforts and support the work of Dr. Witkowski and the team at UChicago Medicine. We also look forward to working closely with the FDA towards our goal of receiving regulatory guidance on a path to market for tegoprubart in islet cell transplantation later this year.”

“Breakthrough T1D is proud to fund the University of Chicago’s clinical trial testing tegoprubart as a novel immunosuppression alternative for use in islet cell transplants and we are very encouraged by the early data,” said Aaron Kowalski, Ph.D., CEO of Breakthrough T1D. “It is exciting to see islet transplant recipients in this trial who no longer need to administer insulin and who are experiencing fewer side effects than with traditional immunosuppressive regimens.”

This UChicago Medicine-initiated clinical trial is funded by Breakthrough T1D, with initial support from The Cure Alliance. Breakthrough T1D has also committed to fund a second study evaluating tegoprubart as part of a calcineurin inhibitor-free immunosuppression drug regimen to prevent islet transplant rejection in individuals with T1D and chronic kidney disease.

About Islet Transplantation for Type 1 Diabetes

Pancreatic islet transplantation is a minimally invasive procedure developed to provide blood glucose control for subjects with type 1 diabetes and minimize or eliminate dependence on insulin. During the procedure, pancreatic islets containing insulin-producing beta cells are isolated from the pancreas of a deceased organ donor and infused through a small catheter into the patient’s liver. The islet cells lodge in small blood vessels in the liver and release insulin. After the procedure, subjects remain on immunosuppression therapy to prevent transplant rejection.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver allograft transplantation and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; Twitter

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s planned clinical trials, the development of product candidates, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with islet cell transplantation, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
[email protected]

Source: Eledon Pharmaceuticals

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Source: Eledon Pharmaceuticals, Inc.

Release – Greenwich LifeSciences Announces Use of Commercially Manufactured GP2 in FLAMINGO-01

Posted on by [email protected]

Research News and Market Data on GLSI

 Download as PDFMarch 16, 2026 6:00am EDT

STAFFORD, Texas, March 16, 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 GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided the following update on the use of commercially manufactured GP2 in FLAMINGO-01.

All US Sites Treating Patients with Commercially Manufactured GP2

The Company previously announced that the first three commercial lots of GP2 active ingredient were manufactured in 2023 in an approved commercial facility, which could be used to prepare approximately 200,000 doses of GP2. In 2024, the first of three commercial lots filling GP2 into vials for commercial sale or for clinical use was manufactured in a commercial facility. In addition, drug stability programs were initiated for all four lots. Data on these commercial lots was recently submitted to the FDA, and after review, the first commercial lot of GP2 vials was approved for use in FLAMINGO-01 in the US.

Within weeks following the FDA review, all approximately 40 US sites were supplied with commercially manufactured GP2 vials and these sites began treating patients with these vials immediately. We were able to efficiently distribute the GP2 vials and communicate with the US pharmacists working with our warehouse partners and through our clinical team, which we internalized in Q4 2025.

CEO Snehal Patel commented, “We have started to submit the same manufacturing information to European, UK, and Canadian regulators so that commercially manufactured GP2 can be approved for use by all approximately 160 sites participating in FLAMINGO-01. We are also planning to manufacture additional vials of GP2, seeking a capacity of 500,000 to 1 million vials of GP2 per year, and to make larger lots of GP2 active ingredient to build inventory for a potential commercial launch.”

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 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 March 16, 2026

The Oncology Institute, Inc. (TOI) – Strong Results Driven By Covered Population Growth With Improving Margins

Posted on by [email protected]


Friday, March 13, 2026

TOI is an oncology practice management company that provides administrative services to oncology clinics. These clinics provide cancer care to a population of approximately 1.9 million patients. Services include cancer care, pharmacy and dispensary services, clinical trials, and services associated with oncology care. The company employs nearly 120 clinicians and over 700 teammates at over 70 clinic locations.

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.

4Q25 Had Strong Revenue Growth. The Oncology Institute reported a 4Q25 loss of $7.5 million or $(0.06) per share and a FY2026 loss of $60.6 million or $(0.54) per share. Importantly, 4Q25 Revenues of $142.0 million were up 41.6% over 4Q24, close to our estimate of $142.4 million, with a slightly different mix from Patient Services and Dispensary Revenues. EBITDA in 4Q25 was $0.15 million, turning positive for the first time, and compares with $(7.8) million in 4Q24. Cash balance on December 31, 2025 was $33.6 million.

Margins Improved During 4Q and For FY2025. Overall Gross Margin for 4Q2025 improved to 16.0% of revenues compared with 14.6% in 4Q2024. This reflects margins improvements in Patient Services of 11.9% compared with 8.9% in 4Q24, and Dispensary margins of 18.1% compared with 16.9% in 4Q24. FY2025 Overall Gross Margin was 15.2% compared with 13.7% for FY2024.


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