Health Archives - Page 32 of 255

Release – GeoVax Highlights Positive Interim Results for Multi-Antigen COVID-19 Vaccine in Immunocompromised Patients at World Vaccine Congress Europe 2025

Posted on October 16, 2025October 16, 2025 by [email protected]

Presentations Underscore Favorable Safety Profile and Robust T-Cell Responses of GEO-CM04S1 in Vulnerable Populations

ATLANTA, GA – October 16, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today announced presentations by its senior scientific leadership at the World Vaccine Congress Europe 2025, held October 13–16 at the RAI Amsterdam Convention Centre in Amsterdam, Netherlands.

Presentation Highlights

Mark J. Newman, PhD – Chief Scientific Officer
Workshop Presentation: “Vaccine design to address the immunocompromised: T-lymphocyte driven…Balanced immunity – Broader specificity – Increased memory.”

Highlighted the limitations of current “one-size-fits-all” vaccines for immunocompromised populations.
Presented Phase 2 data showing GEO-CM04S1 elicits strong T-cell responses to both Spike (S) and Nucleocapsid (N), exceeding responses induced by mRNA boosters.
Demonstrated broad, durable immunity in preclinical and early clinical data, including responses against Omicron subvariants.
Reinforced the potential of GEO-CM04S1 to provide longer-lasting protection and reduce the need for frequent vaccine reformulations.

Kelly T. McKee, Jr., MD, MPH – Chief Medical Officer
Poster Presentation: “Interim Safety and Reactogenicity of GEO-CM04S1, an MVA-vectored, multi-antigen COVID-19 vaccine, in adults with hematologic malignancies receiving cellular therapies.”

Reported interim safety results from a Phase 2 trial in patients with hematologic malignancies post-hematopoietic stem cell transplant or chimeric antigen receptor (CAR)-T cell therapy.
GEO-CM04S1 showed a safety profile comparable to mRNA vaccines, with only mild-to-moderate treatment-emergent adverse events, predominantly injection site reactions, fatigue, and myalgia… observed.
No vaccine-related serious adverse events, myocarditis, or pericarditis have been reported to date.
Breakthrough infections occurred but were mild-to-moderate in severity.

“These data continue to support our conviction that GEO-CM04S1 has the potential to fill a critical gap for immunocompromised patients who are not adequately protected against severe COVID-19 by existing vaccines,” said David Dodd, Chairman & CEO of GeoVax. “Our MVA-based, multi-antigen approach is designed to provide broader, more durable protection, and we are encouraged by the consistent safety profile emerging across the ongoing trials.”

About GEO-CM04S1

GEO-CM04S1 is a synthetic, next-generation COVID-19 vaccine candidate that co-expresses spike (S) and nucleocapsid (N) antigens using GeoVax’s MVA vector platform. Designed to induce both antibody and T-cell responses, GEO-CM04S1 is being evaluated in three Phase 2 clinical trials:

As a primary vaccine for immunocompromised individuals (including post-transplant and hematologic cancer patients),
As a booster for patients with chronic lymphocytic leukemia (CLL), and
As a durable booster for healthy adults previously immunized with mRNA vaccines

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin^®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: 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 – SelectQuote’s Healthcare Select Research Uncovers Critical Gaps in Care, Highlighting Urgent Need for Personalized Healthcare Solutions

Posted on October 16, 2025October 16, 2025 by [email protected]

Research News and Market Data on SLQT

10/15/2025

Nearly 70% of Served Population Face Limited Access to a Local Pharmacy

OVERLAND PARK, Kan.–(BUSINESS WIRE)– SelectQuote, Inc. (NYSE: SLQT) (the “Company”), a leading distributor of Medicare insurance policies and owner of a rapidly-growing healthcare services platform, today released a new research brief offering in-depth insights into the complex medical and social needs of the population it serves. The findings from tens of thousands of patient health needs assessments gathered by the Company’s Healthcare Select division highlight significant challenges across chronic care management, medication access, and financial security, underscoring the critical industry need for personalized, integrated healthcare solutions.

Key Research Findings:

Underserved Beneficiaries: Given that SelectQuote and Healthcare Select connect with beneficiaries telephonically, this population significantly over-indexes in historically-underserved areas lacking significant access to more traditional healthcare providers. 45% of Healthcare Select members reside in a rural zip code and 36% reside in an urban zip code, while only 11% reside in a suburban zip code.
Chronic Conditions: 74% of the population reported that they are dealing with two or more chronic conditions.
High Prescription Use: 75% of members regularly take 5 or more prescriptions.
Financial Headwinds: As 77% of SelectRx patients report annual household income of under $20,000, Social Determinants of Health often compound the treatment of health issues. 19% report having trouble accessing food on a regular basis. 36% indicate they are worried about being able to pay for bills if they were to face a serious illness.
Medication Delays: 16% of Healthcare Select members report having delayed taking medication for financial reasons.
Adherence Challenges: 40% of members have reported either forgetting to take their medications or failing to pick up prescriptions from a pharmacy. Independent studies indicate that failure to take medications consistently as prescribed (i.e., non-adherence) contributes to reduced treatment efficacy and poor disease control, higher rates of emergency department visits and hospitalizations, and increased morbidity and mortality.
Limited Pharmacy Access: Given their geographic concentration, approximately ⅔ of the population served by the Company’s SelectRx pharmacy reside in a “pharmacy desert” with limited access to local pharmacies.
Transportation: The headwinds to quality pharmacy access are exacerbated by the fact that 31% of Healthcare Select members report that they lack access to reliable transportation.

“This research provides a clear, data-driven look at the barriers to care faced by a large segment of the Medicare-eligible population,” said Bob Grant, SelectQuote President. “The high prevalence of chronic conditions, coupled with geographic and financial obstacles, illustrates why traditional one-size-fits-all healthcare is insufficient. We are committed to using this data to drive personalized solutions that effectively address these gaps.”

Mr. Grant continued, “We purpose-built Healthcare Select and our SelectRx pharmacy model to meet the needs of these underserved Medicare beneficiaries by combining telephonic outreach, personalized care coordination, direct prescription delivery, and packaging that improves adherence. By removing barriers like transportation and limited local pharmacy access, SelectRx helps patients manage complex medication regimens and improves adherence, ultimately driving better health outcomes.”

As Healthcare Select works to address members’ most pressing gaps in care — specifically in medication adherence, Social Determinants of Health, remote diagnostics and therapeutics, and chronic condition management — the Company actively seeks partners. SelectQuote invites innovative organizations and solution providers to connect with its Business Development team to collaboratively address these pressing issues impacting member care.

About SelectQuote:

Founded in 1985, SelectQuote (NYSE: SLQT) pioneered the model of providing unbiased comparisons from multiple, highly-rated insurance companies, allowing consumers to choose the policy and terms that best meet their unique needs. Two foundational pillars underpin SelectQuote’s success: a strong force of highly-trained and skilled agents who provide a consultative needs analysis for every consumer, and proprietary technology that sources and routes high-quality leads. Today, the Company operates an ecosystem offering high touchpoints for consumers across insurance, pharmacy, and virtual care.

With an ecosystem offering engagement points for consumers across insurance, Medicare, pharmacy, and value-based care, the company now has three core business lines: SelectQuote Senior, SelectQuote Healthcare Services, and SelectQuote Life. SelectQuote Senior serves the needs of a demographic that sees around 10,000 people turn 65 each day with a range of Medicare Advantage and Medicare Supplement plans. SelectQuote Healthcare Services is comprised of the SelectRx Pharmacy, a Patient-Centered Pharmacy Home™ (PCPH) accredited pharmacy, SelectPatient Management, a provider of chronic care management services, and Healthcare Select, which proactively connects consumers with a wide breadth of healthcare services supporting their needs.

Investor Relations:
Sloan Bohlen
877-678-4083
[email protected]

Media:
Matt Gunter
913-286-4931
[email protected]

Source: SelectQuote, Inc.

Release – Gyre Therapeutics Announces Completion of Patient Enrollment in Phase 3 Clinical Trial of Pirfenidone Capsules for the Treatment of Pneumoconiosis

Posted on October 15, 2025October 15, 2025 by [email protected]

Research News and Market Data on GYRE

October 15, 2025

PDF Version

SAN DIEGO, Oct. 15, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced that its indirect, majority-owned subsidiary, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals), has completed patient enrollment in the 52-week Phase 3 clinical trial of its Class 1 drug, Pirfenidone capsules, for the treatment of pneumoconiosis.

A total of 272 patients have been enrolled in this multicenter, randomized, double-blind, placebo-controlled trial being conducted at 18 clinical research centers across China. The trial is designed to evaluate the efficacy and safety of 52 weeks of Pirfenidone capsule treatment in patients with pneumoconiosis, a chronic occupational lung disease characterized by progressive pulmonary fibrosis.

Unmet Medical Need in Pneumoconiosis

Pneumoconiosis remains the most common and severe occupational disease in China, with more than 450,000 surviving patients and thousands of new cases reported each year. It results from long-term inhalation of mineral dusts such as silica or coal, which triggers persistent inflammation and progressive fibrosis of the lung tissue. Over time, this excessive scar formation causes diffuse fibrosis and irreversible loss of lung function. Despite its prevalence and severity, there is currently no approved therapy in China that specifically targets the fibrotic mechanisms underlying pneumoconiosis.

Based on recent expert consensus, China’s pneumoconiosis treatment landscape represents a significant unmet medical need, underscoring the importance of developing therapies specifically designed to slow or halt the progression of fibrosis and improve long-term outcomes for affected patients.

About the 52-Week Phase 3 Trial

The ongoing trial compares Pirfenidone 1,800 mg/day (600 mg tid) with placebo over a 52-week double-blind treatment period.

Primary Endpoint: Change from baseline in forced vital capacity (FVC) % predicted at Week 52.
Key Secondary Endpoints: Changes in diffusing capacity of the lungs for carbon monoxide (DLCO), 6-minute walk distance, St. George’s Respiratory Questionnaire (SGRQ) score, and Modified Medical Research Council (mMRC) dyspnea scale, as well as rates of acute exacerbations, hospitalizations, and deaths.
Safety Monitoring: Follows Gyre’s Development Safety Update Report (DSUR Dec 2023–Dec 2024). Most adverse events reported to date are mild to moderate, with no unexpected safety signals.
Interim Analysis: None planned.

About Pirfenidone (ETUARY®)

Pirfenidone is an oral antifibrotic small molecule that received its original approval in China in 2011 by Gyre Pharmaceuticals for the treatment of idiopathic pulmonary fibrosis (IPF). It works by inhibiting TGF-β signaling and fibroblast proliferation. Gyre continues to advance Pirfenidone beyond IPF through multiple clinical programs, including the Phase 3 pneumoconiosis trial and the recently approved Phase 2/3 trial for oncology-related pulmonary complications such as radiation-induced lung injury (RILI) and checkpoint inhibitor pneumonitis (CIP).

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 United States. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the People’s Republic of China, 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.

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, including Gyre’s advancement of its Phase 3 trial in China for Pirfenidone capsules for the treatment of pneumoconiosis and the initiation of Gyre’s Phase 2/3 trial in China for Pirfenidone capsules for the treatment of RILI and CIP; and trial design of Gyre’s Phase 3 trial in China for Pirfenidone capsules for the treatment of pneumoconiosis. 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. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 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.

For Investors:
David Zhang
[email protected]

Release – GeoVax Leadership to Participate in Key European Meetings to Advance Partnering Discussions

Posted on October 13, 2025October 13, 2025 by [email protected]

Research News and Market Data on GOVX

Executives to Participate at World Vaccine Congress Europe (Amsterdam, Oct 13–16) and BIO-Europe Fall (Vienna, Nov 3–5), and Meet With NGOs, Industry Partners and Academic Collaborators

ATLANTA, GA – October 13, 2025 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today announced that senior leadership will be in Europe over the coming weeks to advance partnering and collaboration engagement across the Company’s portfolio.

Chairman & Chief Executive Officer David A. Dodd and John Sharkey, PhD, Vice President, Business Development & Executive Lead for Mpox/Smallpox, together with other members of GeoVax’s senior team, will attend and host meetings at:

World Vaccine Congress Europe 2025 – October 14–16, 2025 | Amsterdam, Netherlands
BIO-Europe 2025 Fall – November 3–5, 2025 | Vienna, Austria

In addition to conference activities, the team will conduct meetings with global NGOs, including WHO, UNICEF, CEPI, Gavi, and the Africa CDC, as well as with established and prospective academic institutional collaborators across Europe.

“We are focused on solidifying durable relationships that can accelerate development in support of expanded access to critical vaccines and immunotherapies,” said David A. Dodd, Chairman & CEO of GeoVax. “We’re engaging with global health leaders and prospective partners to align on near-term opportunities in mpox/smallpox preparedness, addressing the critically unmet needs of immunocompromised patients relative to COVID-19, expanding the development breadth of Gedeptin^® as neoadjuvant cancer therapy, and to explore complementary collaborations across our broader platform.”

Partnering Focus Areas

GeoVax will highlight opportunities spanning its pipeline and technology platforms, including (but not limited to):

GEO-MVA (Mpox/Smallpox vaccine candidate): U.S.-based MVA program designed to accelerate access to a second-source of the critically needed GEO-MVA vaccine and rapid, scalable MVA manufacturing.
GEO-CM04S1 (multi-antigen COVID-19 vaccine): Designed to elicit robust T-cell and antibody responses; partnering priorities focused on addressing the current unmet needs of an estimated over 400 million immunocompromised patients worldwide.
Gedeptin^® (gene-directed enzyme prodrug therapy): A tumor-targeted immuno-oncology approach with potential combination synergies with checkpoint inhibitors, providing a potential new neoadjuvant therapy against solid tumors.
Broader MVA platform applications: Hemorrhagic fever and Zika programs; continuous cell-line manufacturing and potential technology-transfer collaborations.

“We continue to receive compelling interest from governments, NGOs, and potential industry collaborators, seeking diversified, resilient vaccine supply and clinically differentiated immunotherapies,” added Dr. John Sharkey. “Our goal is to convert that interest into structured collaborations that accelerate development, manufacturing readiness, and regional availability.”

Request a Meeting

Organizations interested in meeting with GeoVax during WVC Europe (Amsterdam, Oct 14–16) or BIO-Europe Fall (Vienna, Nov 3–5) – or at separate times/locations in Europe – are encouraged to contact:

Business Development: [email protected]
Investor Relations: [email protected]

Additional information about GeoVax and its programs is available at www.geovax.com.

About GeoVax

Forward-Looking Statements

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected]

Release – Greenwich LifeSciences Announces Addition of Austria to Flamingo-01 Clinical Trial

Posted on October 9, 2025October 9, 2025 by [email protected]

Research News and Market Data on GLSI

Download as PDF October 09, 2025 6:00am EDT

STAFFORD, Texas, Oct. 09, 2025 (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 announced the expansion of FLAMINGO-01 clinical trial to Austria.

The Company’s application to European regulators has been formally approved, adding Austria as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, Ireland, Portugal, Belgium, and the US.

According to the latest data collected by the European Cancer Information System (click here), a total of 6,070 new cases of breast cancer were diagnosed in Austria in 2022, which is the most common cancer diagnosed in women, representing approximately 28% of all cancers in women. Breast cancer is the leading cause of death from cancer in women in Austria with 1,789 deaths in 2022.

CEO Snehal Patel commented, “We are collaborating with principal investigators at the Ordensklinikum Linz in Upper Austria. The site approached the Company after patients asked about participating in FLAMINGO-01. We recently visited the site in Linz, where we started training activities. We hope to activate the site this year and plan to further develop the geographic strategy for Austria, where we are considering additional sites in Vienna and Salzburg.”

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of 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 will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will 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]

Source: Greenwich LifeSciences, Inc.

Released October 9, 2025

Novo Nordisk Acquires Akero Therapeutics in $5.2 Billion Deal to Bolster MASH Treatment Pipeline

Posted on October 9, 2025October 9, 2025 by [email protected]

Novo Nordisk is making another bold move in the metabolic disease space with its latest agreement to acquire Akero Therapeutics for up to $5.2 billion, marking one of the year’s largest biotech takeovers. The deal strengthens Novo Nordisk’s expanding presence in liver and metabolic disorders, while delivering significant value to Akero’s shareholders.

Under the terms of the agreement announced Thursday, Akero investors will receive $54 per share in cash at closing, plus a contingent value right (CVR) worth up to an additional $6 per share. The CVR payment would be triggered upon full U.S. regulatory approval of Akero’s lead drug candidate, efruxifermin (EFX), for treating compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH) by June 2031.

The acquisition values Akero at roughly $4.7 billion upfront, representing a 42% premium to its pre-rumor share price earlier this year. If all conditions are met, the total value could reach $5.2 billion — a 57% premium compared to Akero’s May 2025 valuation.

For Novo Nordisk, the deal builds on its leadership in GLP-1–based therapies and signals a deepening commitment to addressing complex metabolic diseases. Akero’s EFX program, designed to treat MASH, a condition historically known as NASH (nonalcoholic steatohepatitis), complements Novo Nordisk’s existing pipeline of cardiometabolic treatments. EFX’s potential to reverse fibrosis and improve liver function positions it as a promising therapy for millions of patients with few available options.

MASH has become a growing global health concern, closely linked to obesity and type 2 diabetes—areas where Novo Nordisk already dominates through blockbuster drugs like Ozempic and Wegovy. Integrating Akero’s research could help the Danish pharmaceutical giant extend its reach beyond diabetes and into liver health, strengthening its competitive advantage as demand for metabolic therapies surges worldwide.

Industry analysts see the deal as part of a broader wave of consolidation among biotechs developing metabolic and inflammatory treatments. Major pharmaceutical companies are increasingly acquiring smaller firms with advanced-stage assets to accelerate innovation and diversify revenue streams.

Akero’s ongoing Phase 3 SYNCHRONY trials have shown encouraging signs that EFX can reduce fibrosis and resolve MASH, potentially transforming the standard of care. The company’s holistic approach — improving both liver health and cardiovascular risk factors — aligns well with Novo Nordisk’s long-term goal of offering comprehensive solutions for metabolic dysfunction.

Following the acquisition, Akero’s operations will be integrated into Novo Nordisk’s global research network, with plans to advance EFX through late-stage trials and prepare for commercial launch. The transaction, unanimously approved by Akero’s board, is expected to close by year-end pending shareholder and regulatory approvals.

Financial advisors for the deal include Morgan Stanley and J.P. Morgan Securities, with Kirkland & Ellis LLP serving as legal counsel to Akero.

The acquisition underscores Novo Nordisk’s strategy to expand beyond diabetes and obesity treatments into adjacent metabolic diseases with large unmet medical needs. If EFX achieves approval and commercial success, the deal could mark a defining moment in the evolution of liver disease therapeutics—and another milestone in Novo Nordisk’s transformation into a powerhouse across metabolic health.

Release – Nutriband Files Provisional Patent Application for Enhanced Transdermal Abuse Deterrent Technology

Posted on October 8, 2025October 8, 2025 by [email protected]

Research News and Market Data on NTRB

October 08, 2025 08:30 ET | Source: Nutriband Inc.

Nutriband files provisional patent application to enhance its AVERSA™ transdermal abuse deterrent technology being developed for patches containing opioids and stimulants with a potential for abuse.

Nutriband’s AVERSA™ abuse-deterrent technology consists of a proprietary aversive agent coating that employs taste aversion to deter oral abuse and reduce accidental exposure.

ORLANDO, Fla., Oct. 08, 2025 (GLOBE NEWSWIRE) — Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of prescription transdermal pharmaceutical products, today announced that it has filed a provisional patent application with the U.S. Patent and Trademark Office (USPTO) to further strengthen Nutriband’s intellectual property protection for its AVERSA™ abuse deterrent transdermal technology.

The provisional patent application covers improved aversive formulations and coating application methods to enhance the abuse deterrent properties of Nutriband’s AVERSA™ transdermal technology and make it even more difficult to defeat. If this provisional patent application is converted into a non-provisional patent application and a new patent is subsequently granted, it could significantly extend the patent protection for products that utilize Nutriband’s AVERSA™ abuse deterrent technology as the statutory patent term of a US patent is 20 years from the non-provisional filing date.

The AVERSA™ abuse deterrent technology is protected by a broad international intellectual property portfolio with patents issued in 46 countries including the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

Nutriband’s AVERSA™ abuse-deterrent technology can be utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential including opioids and stimulants. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as opioids, while making sure that these drugs remain accessible to those patients who really need them.

About AVERSA™ Abuse-Deterrent Transdermal Technology

Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, including opioids and stimulant drugs, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.

About Nutriband Inc.

We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

The Company’s website is www.nutriband.com. Any material contained in or derived from the Company’s websites or any other website is not part of this press release.

Forward-Looking Statements

Certain statements contained in this press release, including, without limitation, statements containing the words ‘’believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s Form S-1, Forms 10-K’s and Forms 10-Q’s, and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

Contact Information:

Nutriband Inc.
Phone: 407-377-6695
Email: [email protected]

SOURCE: Nutriband Inc.

Release – Cocrystal Pharma to Present at Noble Capital Markets Emerging Growth Virtual Equity Conference

Posted on October 2, 2025October 2, 2025 by [email protected]

Research News and Market Data on COCP

October 02, 2025

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BOTHELL, Wash., Oct. 02, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that James Martin, CFO and co-CEO, will present a company overview at the Noble Capital Markets Emerging Growth Virtual Equity Conference on Thursday, October 9, 2025 at 12:00 pm Eastern time (9:00 a.m. Pacific time). The formal presentation will be followed by a hosted question-and-answer session with questions welcomed from the live virtual audience.

Those interested in viewing the live Cocrystal presentation can register for the event here. A video webcast of the presentation will be available within 48 hours following the event on the Company’s website and archived for 90 days.

Mr. Martin will be available throughout the conference for virtual one-on-one meetings with registered, qualified investors. Meetings can be scheduled by contacting Giorgia Pigato here at Noble Capital Markets.

About Noble Capital Markets, Inc.
Noble Capital Markets is a research-driven investment bank that has supported small and microcap companies since 1984. As a FINRA and SEC licensed broker dealer, Noble provides institutional-quality equity research, merchant and investment banking, and order execution services. In 2018, Noble launched Channelchek—an investor community dedicated exclusively to public small and micro-cap companies and their industries. Channelchek is the first service to offer investors free institutional-quality research without a subscription.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company that addresses significant unmet needs by developing innovative antiviral treatments for challenging diseases including influenza, viral gastroenteritis, COVID, and hepatitis. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs.

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

# # #

Source: Cocrystal Pharma, Inc.

Released October 2, 2025

Release – MariMed’s InHouse Brand Again Supports Veterans Facing Housing Challenges With Second Annual Help on the Homefront Campaign

Posted on October 1, 2025October 1, 2025 by [email protected]

Research News and Market Data on MRMD

October 01, 2025 9:13am EDT Download as PDF

Local Veterans in Maryland, Massachusetts, Delaware, and Illinois Can Enter to Win $5,000 to Help Offset the Cost of Housing or Home Improvements through November 30

NORWOOD, Mass., Oct. 01, 2025 (GLOBE NEWSWIRE) — InHouse™ announced today the launch of its second annual Help on the Homefront campaign, a philanthropic effort that provides veterans the chance to win funds to help offset their cost of housing or home improvements. Help on the Homefront debuted in 2024 to raise awareness of the nationwide issue of veteran housing challenges and homelessness. InHouse, a line of cannabis high quality flower, vapes, and gummies, is produced and distributed by leading multi-state cannabis operator, MariMed Inc. (“MariMed”) (CSE:MRMD) (OTCQX: MRMD).

From October 1 – November 30, 2025, qualifying veterans can apply for a chance to win $5,000 to help reduce the financial burden of their housing costs. One veteran in each of four MariMed retail markets, including Maryland, Massachusetts, Delaware, and Illinois, will be awarded the funds to help make vital home improvements or contribute to the payment of their rent or mortgage.

Veterans who are age 21 and over can enter Help on the Homefront in-store at one of MariMed’s Thrive dispensaries, or online by visiting www.inhousecannabis.com/veterans. No purchase is necessary to participate. Friends and family members are also welcome to submit an entry on a veteran’s behalf. One winner from each market will be randomly selected before the end of the year.

“MariMed and our InHouse brand are committed to serving local communities by finding ways to provide support to those in need. Help on the Homefront is part of that commitment, and we’re thrilled the campaign will once again deliver financial support that will make a real difference in the lives of veterans,” said MariMed Chief Operating Officer Tim Shaw, himself a veteran who served in the U.S. Army earlier in his career.

About InHouse
InHouse is MariMed’s value-priced line of flower, vapes, and gummies. The brand prides itself on offering a variety of high-quality cannabis products that are highly enjoyable for everyone. Whether you’re a cannabis newcomer or a seasoned expert, InHouse has you covered with hand-grown flower, tasty vapes in flavors and strains, and all-natural fast-acting gummies. For more information on InHouse please visit www.inhousecannabis.com.

About MariMed
MariMed Inc. is a leading multi-state cannabis operator, known for developing and managing state-of-the-art cultivation, production, and retail facilities. Our award-winning portfolio of cannabis brands, including Betty’s Eddies™, Bubby’s Baked™, Vibations™, InHouse™, and Nature’s Heritage™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. With a commitment to excellence, MariMed continues to drive growth and set new standards in the cannabis industry. For additional information, visit www.marimedinc.com.

Media Contact:
Zach Galasso
DPA Communications
Email: [email protected]
Phone: (978) 604-5423

Company Contact:
Howard Schacter
Chief Communications Officer
Email: [email protected]
Phone: (781) 277-0007

Release – Tonix Pharmaceuticals Further Strengthens Commercial Leadership Team with Appointment of Ganesh Kamath as Head of Market Access

Posted on September 30, 2025September 30, 2025 by [email protected]

Research News and Market Data on TNXP

September 30, 2025 8:30am EDT Download as PDF

Mr. Kamath brings more than 25 years of market access, pricing, and commercial operations experience to Tonix

On August 15, 2025, the U.S. Food and Drug Administration approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults, the first new fibromyalgia therapy in more than 15 years

US Launch of Tonmya expected in the fourth quarter of 2025

CHATHAM, N.J., Sept. 30, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced the appointment of Ganesh Kamath as Head of Market Access, effective September 29, 2025.

“Ganesh brings deep expertise in market access and a history of delivering results at leading global organizations, including Bayer HealthCare, Hutchmed International, and CuriaGlobal,” said Thomas Englese, EVP Commercial of Tonix Pharmaceuticals. “As we prepare for the commercial launch of Tonmya™ and continue advancing our pipeline, his leadership in pricing, contracting, and payer engagement will help ensure patients have timely access to our therapies while driving operational momentum across the business.”

Most recently, Mr. Kamath served as Vice President of FP&A, Business Development, and Sales Operations at CuriaGlobal, where he led strategic initiatives to strengthen business development and operational performance. Prior to that, he was Senior Vice President and Chief Financial Officer at Hutchmed International, where he established pricing governance frameworks and advanced market access strategies. Earlier in his career, he held senior leadership roles at Bayer HealthCare within Finance and Market Access, overseeing strategic pricing, contracting, reimbursement and gross to net management across a portfolio of more than 25 brands. Mr. Kamath is a Chartered Accountant and holds a Bachelor of Science from the University of Calicut.

“Joining Tonix at this pivotal time presents an opportunity to help unlock the commercial value of Tonmya as we prepare to bring it to market for patients with fibromyalgia,” said Ganesh Kamath. “I look forward to working with Tonix’s leadership team to drive operational execution, and position the company for long-term growth across the portfolio.”

Tonix Pharmaceuticals Holding Corp.*

Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix recently received FDA approval for Tonmya^TM, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments for acute migraine in adults. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.

* 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.

This press release and further information about Tonix can be found at www.tonixpharma.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 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. There are a number of 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, risks related to the failure to successfully launch and commercialize Tonmya and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. 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 Contact
Ray Jordan
Putnam Insights
[email protected]

INDICATION

TONMYA is indicated for the treatment of fibromyalgia in adults.

CONTRAINDICATIONS

TONMYA is contraindicated:

In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected.

With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.

During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.

In patients with hyperthyroidism.

WARNINGS AND PRECAUTIONS

Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.

Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.

Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.

Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.

CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities.

Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

DRUG INTERACTIONS

MAO inhibitors: Life-threatening interactions may occur.

Other serotonergic drugs: Serotonin syndrome has been reported.

CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.

Tramadol: Seizure risk may be enhanced.

Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).

Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.

Pediatric use: The safety and effectiveness of TONMYA have not been established.

Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.

Please see additional safety information in the full Prescribing Information.

To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Source: Tonix Pharmaceuticals Holding Corp.

Released September 30, 2025

Release – Greenwich LifeSciences Announces Addition of Portugal to Flamingo-01 Clinical Trial

Posted on September 30, 2025September 30, 2025 by [email protected]

Research News and Market Data on GLSI

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September 30, 2025 6:00am EDT

STAFFORD, Texas, Sept. 30, 2025 (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 announced the expansion of FLAMINGO-01 clinical trial to Portugal.

The Company’s application to European regulators has been formally approved, adding Portugal as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, Ireland, and the US.

According to the latest data collected by the European Cancer Information System (click here), a total of 9,065 new cases of breast cancer were diagnosed in Portugal in 2022, which is the most common cancer diagnosed in women, representing approximately 30% of all cancers in women. Breast cancer is the leading cause of death from cancer in women in Portugal with 2,211 deaths in 2022.

Luís António Marques da Costa, MD, PhD, will be serving as the national principal investigator in Portugal for FLAMINGO-01. Dr. Costa is an Associate Professor of Medicine, Oncology & Oncobiology, FML-UL, Lisbon, Portugal, and Head of the Clinical Translational Oncology Research Unit at the Institute of Molecular Medicine. He has also served as Director of the Oncology Department at Hospital de Santa Maria in Lisbon since 2005. At the School of Medicine, he is the Coordinator Professor of “Oncobiologia” a new teaching unit that aims to teach the understanding of clinical oncology through molecular medicine. He is involved in multiple clinical trials in breast cancer and other solid tumors, and his research interests have long centered on the area of bone metastases. In recent years, his research has focused on understanding the molecular mechanisms of tumor progression at metastatic sites using bone metastases as a paradigm.

CEO Snehal Patel commented, “We look forward to collaborating with Dr. Costa and his colleagues. We were introduced to Dr. Costa by a member of our steering committee. We recently visited Lisbon to begin start-up activities and to meet our investigators to develop a strategy for Portugal. We are in the process of activating sites in Lisbon and are reviewing additional sites in central and northern Portugal.”

About FLAMINGO-01 and GLSI-100

About Breast Cancer and HER2/neu Positivity

About Greenwich LifeSciences, Inc.

Forward-Looking Statement Disclaimer

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]

Source: Greenwich LifeSciences, Inc.

Released September 30, 2025

Release – MAIA Biotechnology Announces $2.25 Million Private Placement

Posted on September 30, 2025September 30, 2025 by [email protected]

Research News and Market Data on MAIA

September 29, 2025 4:30pm EDT Download as PDF

CHICAGO, IL, Sept. 29, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,733,766 shares of common stock at a purchase price of $1.30 per share, in a private placement to accredited investors and a Company director. Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $1.57 per share, which price represents the “Minimum Price” as defined under NYSE American Rule 713 (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six-months following issuance and have a term of three years from the issuance date. The securities being sold to the Company director participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about October 1, 2025, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering are expected to be approximately $2.25 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for to fund the execution of Step 1 of Part C of the Phase II trial THIO -101 and for working capital.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

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

About 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) completion of the private placement, (ii) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (iii) our ability to advance product candidates into, and successfully complete, clinical studies, (iv) the timing or likelihood of regulatory filings and approvals, (v) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (vi) the rate and degree of market acceptance of our product candidates, (vii) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (viii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, 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]

Source: MAIA Biotechnology, Inc.

Released September 29, 2025

Release – MariMed Announces Third Quarter 2025 Earnings Date

Posted on September 29, 2025September 29, 2025 by [email protected]

Research News and Market Data on MRMD

September 29, 2025 7:30am EDT Download as PDF

NORWOOD, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) — MariMed Inc. (“MariMed” or the “Company”) (CSE: MRMD) (OTCQX: MRMD), a leading cannabis consumer packaged goods company and retailer, announced today it will report its third quarter 2025 financial results on November 5, 2025 after the markets close. Management will host a conference call on November 6, 2025 at 8:00 a.m. EDT to discuss financial results.

A webcast will be available and can be accessed via MariMed’s Investor Relations website at MariMed Q325 Earnings Webcast. A playback of the call will also be made available on MariMed’s Investor Relations website.

About MariMed
MariMed Inc. is a leading multi-state cannabis operator, known for developing and managing state-of-the-art cultivation, production, and retail facilities. Our award-winning portfolio of cannabis brands, including Betty’s Eddies™, Bubby’s Baked™, InHouse™, Nature’s Heritage™, and Vibations™, sets us apart as an industry leader. These trusted brands, crafted with quality and innovation, are recognized and loved by consumers across the country. With a commitment to excellence, MariMed continues to drive growth and set new standards in the cannabis industry. For additional information, visit www.marimedinc.com.

Company Contact:
Howard Schacter
Chief Communications Officer
Email: [email protected]
Phone: (781) 277-0007

Source: MariMed Inc.

Released September 29, 2025