Category: Health

Release – MAIA Biotechnology Highlights Ongoing Momentum of Ateganosine Clinical Program at SITC 2025

Posted on by aweinsoff@channelchek.com

Research News and Market Data on MAIA

November 21, 2025 9:01am EST Download as PDF

Company confirms 12 patients enrolled in Phase 2 THIO-101 to date as expansion trial adds new countries

Posters for Phase 2 and Phase 3 clinical trials available

CHICAGO , Nov. 21, 2025 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced highlights from two poster presentations delivered at SITC 2025, an annual conference hosted by the Society for Immunotherapy of Cancer, held November 5-9, 2025, in National Harbor, MD. The Trials in Progress posters focus on MAIA’s ongoing Phase 2 THIO-101 expansion (Part C) and Phase 3 THIO-104 clinical trials of its first-in-class small molecule telomere targeting agent, ateganosine, as a treatment for non-small cell lung cancer (NSCLC). The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ateganosine for the treatment of NSCLC.

MAIA’s Sr. Medical Director, Victor Zaporojan, M.D., presenter at SITC 2025 commented, “It was a privilege to return to SITC for its 40th anniversary. This event was an ideal forum to highlight the continued success of our Phase 2 clinical trial. We are making steady progress in the expansion phase of this trial, with patient enrollment now underway in European Medicines Agency (EMA) countries. Sites in Hungary and Poland, which were instrumental in Parts A and B of the trial, are actively screening patients along Turkey and Taiwan, and we have 12 patients enrolled in the expansion to date. We expect further momentum in identifying and enrolling patients for THIO-101 Part C in the near term”.

“We also began screening patients in our Phase 3 trial, THIO-104, and noticed great excitement from physicians in the sites we’re bringing our trial to,” added MAIA CEO Vlad Vitoc, M.D. “In this population, third-line NSCLC patients resistant to chemo and immunotherapy, current treatments show overall survival (OS) of around 6 months, and based on the 17.8 months OS observed in THIO-101 to date, we believe that our Phase 3 trial could lead to an early commercial approval of ateganosine by the FDA. It’s only a matter of successful execution to bring our novel NSCLC treatment to this large patient population with significant unmet medical need.”

The posters presented at SITC 2025 feature trial designs for the Phase 2 and Phase 3 studies in advanced NSCLC patients receiving ateganosine followed by a checkpoint inhibitor, cemiplimab (Libtayo®). As of September 17, 2025, a patient that began therapy in March 2023 in the THIO-101 Phase 2 trial has shown survival of 30 months, or 912 days.

“A novel therapy with proven efficacy, such as ateganosine, could strengthen existing treatment strategies and further advance the principles of precision oncology in lung cancer care worldwide,” said Tomasz Jankowski, M.D., Ph.D., key investigator for THIO-101 in Poland and co-author of many of MAIA’s scientific posters. “In Poland, where improving outcomes in advanced NSCLC remains a central focus, ateganosine has the potential to become an important addition to the therapeutic landscape, offering new hope for patients and clinicians alike.”

The posters presented at SITC 2025 were attached as exhibits to a Current Report on Form 8-K filed by the Company with the Securities and Exchange Commission (the “Commission”) on November 7, 2025 and available on the Commission’s website at www.sec.gov. In addition, the posters were made available on MAIA’s website at maiabiotech.com/publications on November 7, 2025.

  • Presentation 1: A Phase 3 Study of Ateganosine (THIO) Sequenced with Immune Checkpoint Inhibitor (ICI) versus Standard of Care Chemotherapy in ICI-Resistant Advanced NSCLC: THIO-104 Trial in Progress
  • Presentation 2: A Phase 2 Study of Ateganosine (THIO; 6-thio-2′-deoxyguanosine) in Combination with Immune Checkpoint Inhibitor (ICI) in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Resistant to Prior ICI and Chemotherapy: THIO-101 Trial in Progress

About Ateganosine

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

About THIO-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About MAIA Biotechnology, Inc.

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

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) 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
ir@maiabiotech.com

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Source: MAIA Biotechnology, Inc.

Released November 21, 2025

Eli Lilly Becomes the First $1 Trillion Drugmaker as Weight-Loss Boom Reshapes Big Pharma

Posted on by slightbourne@noblecapitalmarkets.com

Eli Lilly has officially crossed the $1 trillion valuation mark, becoming the first pharmaceutical company in history to join a market-cap club previously dominated almost entirely by technology giants. The milestone reflects a dramatic reshaping of the healthcare landscape, driven by surging global demand for next-generation weight-loss and metabolic health treatments.

Lilly’s rise has been nothing short of extraordinary. The company’s stock has rallied more than 35% this year alone, fueled largely by explosive growth in the obesity-drug category. Over the past two years, new and highly effective treatments have transformed weight-loss medicine into one of the most profitable segments in all of healthcare. What was once a niche market is now a multibillion-dollar engine attracting unprecedented consumer, medical, and investor interest.

At the center of Lilly’s success are two blockbuster drugs: tirzepatide, marketed as Mounjaro for type 2 diabetes and Zepbound for obesity. Together, they have rapidly climbed to the top of global pharmaceutical sales charts, surpassing even Merck’s cancer drug Keytruda — long considered untouchable as the world’s best-selling medication.

Although rival Novo Nordisk pioneered the modern obesity-drug movement with Wegovy, Lilly seized momentum after early supply shortages hampered Wegovy’s rollout. Stronger clinical results, faster manufacturing scale-up, and broader distribution helped Lilly pull ahead in prescriptions and capture the spotlight as the dominant player in the sector.

The company’s latest quarterly results underscore that shift. Lilly generated more than $10 billion in revenue from its obesity and diabetes medicines—over half of its total $17.6 billion in quarterly sales. Investors now value the company at nearly 50 times its expected earnings, signaling confidence that demand for metabolic-health treatments will remain powerful for years.

The broader market seems convinced as well. Since Zepbound’s launch in late 2023, Lilly shares have surged more than 75%, outpacing the S&P 500’s impressive run. Wall Street analysts estimate the global weight-loss drug market could reach $150 billion by 2030, with Lilly and Novo Nordisk expected to control the vast majority of those sales.

Looking ahead, investors are closely watching Lilly’s upcoming oral obesity drug, orforglipron, which could receive approval as early as next year. Analysts expect it to extend the company’s dominance by offering a pill-based alternative to injectable GLP-1 medications—an option that could unlock even wider adoption.

Beyond drug development, Lilly’s growth is poised to benefit from planned U.S. manufacturing expansions and a federal pricing agreement that is expected to increase patient access. Although the deal may reduce short-term revenue per dose, analysts believe the expanded eligibility—potentially adding tens of millions of U.S. patients—will dramatically enlarge the long-term market.

With its market cap now rivaling major tech players, Lilly is increasingly being viewed as a “Magnificent Seven-style” stock again—an alternative for investors seeking high-growth prospects outside AI and digital infrastructure. Still, challenges remain, including pricing pressure and the need to sustain manufacturing capacity at unprecedented scale.

For now, Lilly’s ascent to the $1 trillion tier signals a new era in which metabolic-health innovation, not just technology, can redefine global market leadership.

Release – Ocugen CEO to Present at NobleCon21—Noble Capital Markets’ Twenty-First Annual Emerging Growth Equity Conference

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

November 20, 2025

PDF Version

MALVERN, Pa., Nov. 20, 2025 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen will present at NobleCon21—Noble Capital Markets’ Twenty-First Annual Emerging Growth Equity Conference at Florida Atlantic University, Executive Education Complex in Boca Raton, FL.

“I look forward to sharing the meaningful progress Ocugen has made toward our goal of three BLAs in three years, along with updates on exciting near-term catalysts in 2026, during this important conference,” said Dr. Musunuri. “NobleCon provides a forum to differentiate Ocugen’s scientific platform among our peers in ophthalmology and share how we are addressing major blindness diseases with a single, one-time gene therapy for life.”

Details regarding the presentation and fireside chat are as follows:
Date: Wednesday, December 3, 2025
Location: Presentation Room 2
Time: 1 p.m. ET  

In addition to Dr. Musunuri’s session, members of Ocugen’s executive team will conduct one-on-one meetings with investors to highlight the Company’s business and clinical development strategy across its unique modifier gene therapy platform.

A high-definition video webcast of the presentation will be available the following day on the Company’s website, and as part of a complete catalog of presentations available at Noble Capital Markets’ Conference website and on Channelchek, the investor portal created by Noble. The webcast will be archived on the Company’s website, the NobleCon website, and Channelchek.com for 90 days following the event. 

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

About Noble Capital Markets, Inc.
Established in 1984, Noble Capital Markets (Noble) is an SEC/FINRA registered full-service broker-dealer offering investment/merchant banking and advisory services, with an award-winning research team, and a proprietary research distribution platform (Channelchek). Noble provides middle-market expertise to entrepreneurs, corporations, financial sponsors, and investors. In addition to its large scale in-person conference, NobleCon, Noble hosts multi-sector virtual conferences throughout the year. Over the more than 40 years, Noble has raised billions of dollars for companies and published more than 45,000 equity research reports. www.noblecapitalmarkets.com | www.nobleconference.com.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com
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Release – Cadrenal Therapeutics CEO, Quang X. Pham, Receives BioFlorida’s Executive of the Year Award

Posted on by aweinsoff@channelchek.com

Research News and Market Data on CVKD

PONTE VEDRA, Fla., Nov. 19, 2025 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome current gaps in anticoagulation therapy, today announced its Chairman and Chief Executive Officer, Quang X. Pham, received the prestigious BioFlorida, Inc. “Executive of the Year Award,” at the recently held Florida Innovation Conference, powered by BioFlorida, in Orlando.

As the voice of Florida’s life-science ecosystem, BioFlorida represents biotechnology, medical-technology, digital health and health system organizations across the state and is committed to advancing innovation, economic growth and patient-impacting therapies.

“Our Executive of the Year Award underscores the remarkable leadership and vision that Quang has brought to Cadrenal and to Florida’s biotech sector,” said Mark A. Glickman, CEO of BioFlorida. “He exemplifies the entrepreneurial spirit and patient-centric innovation that our state’s life sciences community stands for.”

Under Pham’s leadership, Cadrenal has uniquely positioned itself to address gaps in anticoagulation treatment of multiple indications through the development of two differentiated anticoagulants (tecarfarin and frunexian). He founded Cadrenal after a distinguished career that includes founding other life-science and digital-health firms, as well as service as a U.S. Marine Corps officer.

“I am deeply honored to receive this recognition from BioFlorida,” said Pham. “BioFlorida has been by our side from day one. Our team is motivated every day by the patients who have few options for safe and effective anticoagulation. This award is a tribute to all of them.”

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a biopharmaceutical company with a mission to develop novel and differentiated biopharmaceutical products that bridge critical gaps in current acute and chronic anticoagulant therapy. We bridge these gaps by developing novel and differentiated anticoagulants, or blood thinners, designed to provide greater predictability, increased stability, more precise control, and fewer bleeding complications. We currently have two clinical-stage assets: tecarfarin, an oral vitamin K antagonist (VKA) for chronic use, and frunexian, a parenteral small-molecule Factor XIa antagonist for use in acute hospital settings. By targeting underserved patient populations and advancing therapies designed for both chronic and acute use, we aim to reshape standards of care in anticoagulation. For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding developing transformative therapeutics to overcome current gaps in anticoagulation therapy and positioning the Company to address gaps in anticoagulation treatment of multiple indications through the development of two differentiated anticoagulants. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to develop transformative therapeutics to overcome current gaps in anticoagulation therapy, the ability to successfully complete clinical trials on time and achieve desired results and benefits as expected and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

Release – Tonix Pharmaceuticals Announces U.S. Commercial Availability of TONMYA™ (cyclobenzaprine HCl sublingual tablets) as a First-in-Class Fibromyalgia Treatment

Posted on by slightbourne@noblecapitalmarkets.com

November 17, 2025 7:00am EST

CHATHAM, N.J., Nov. 17, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced today that TONMYATM (cyclobenzaprine HCl sublingual tablets) is now commercially available at pharmacies by prescription in the United States. TONMYA is a first-in-class treatment for fibromyalgia in adults as a non-opioid analgesic taken once daily at bedtime.

“The availability of TONMYA is a momentous day for Tonix, providing the estimated 10 million people living with fibromyalgia a novel treatment that has been shown to address the debilitating, core symptom of this disease, widespread pain,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “After more than 15 years without innovation for this disease, we are honored to bring this new treatment option to patients in partnership with the full fibromyalgia community including researchers, patients, and investigators. We are excited and motivated to make TONMYA accessible to as many patients as possible.”

The latest Phase 3 trial, RESILIENT, was published in Pain Medicine with data on primary endpoints measuring pain, and secondary endpoints measuring patient’s global impression of change, patient-reported symptoms and function, sleep disturbance, and fatigue.

“For years, fibromyalgia patients have struggled with limited treatment options that often fall short. The availability of TONMYA marks a meaningful advancement by targeting neurotransmitters thought to be involved in fibromyalgia,” said Andrea L. Chadwick, M.D., MSc, FASA, Anesthesiology, Pain, and Perioperative Medicine at The University of Kansas Health System.

“We’re truly excited about this new option for people living with fibromyalgia,” said Sharon Waldrop, a person with lived experience and founder of the Fibromyalgia Association. “The availability of TONMYA provides new hope for our community and represents a crucial step forward in fibromyalgia treatment.”

TONMYA was approved by the FDA on August 15, 2025.

The approval incorporated efficacy from two double-blind, randomized, placebo-controlled, Phase 3 clinical trials of nearly 1,000 patients in total that evaluated TONMYA as a bedtime treatment for fibromyalgia. Across both Phase 3 trials, TONMYA significantly reduced daily pain scores compared to placebo at 14 weeks, the primary endpoint. Additionally, a greater percentage of study participants taking TONMYA experienced a clinically meaningful (≥30%) improvement in their pain after three months, compared to placebo.

Across three Phase 3 clinical trials with over 1,400 patients evaluated, TONMYA was generally well tolerated. The most common adverse events (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) included oral hypoesthesia (numbness in the mouth), oral discomfort, abnormal product taste, somnolence (drowsiness), oral paresthesia (tingling, pricking or burning in the mouth), oral pain, fatigue, dry mouth, and aphthous ulcer (canker sore).

For more information, visit TonmyaHCP.com

About Fibromyalgia
Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 10 million adults in the U.S., approximately 80% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep (waking up tired and unrefreshed), fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Patients with fibromyalgia have double the medical costs compared to the general population in the U.S.

About TONMYATM (cyclobenzaprine HCl sublingual tablets)
TONMYA, which was investigated as TNX-102 SL, is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride, which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a tertiary amine tricyclic (TAT) and multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TONMYA is now commercially available as a once-daily bedtime treatment for fibromyalgia in adults. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10357465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary composition. These patents are expected to provide TONMYA with U.S. market exclusivity until 2034. Pending patent applications related to method of use could extend exclusivity until 2044.

About the Phase 3 Clinical Trials: RELIEF and RESILIENT
The RELIEF and RESILIENT studies were double-blind, randomized, placebo-controlled trials designed to evaluate the efficacy and safety of TONMYATM (cyclobenzaprine hydrochloride sublingual tablets) for the treatment of fibromyalgia. RELIEF and RESILIENT were two-arm trials that enrolled 503 and 457 adults with fibromyalgia across 40 and 33 United States sites, respectively. In both trials, the first two weeks of treatment consisted of a run-in period in which participants started on TONMYA 2.8 mg (1 tablet) or placebo. Thereafter, all participants increased their dose to TONMYA 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks. The primary endpoint across both trials was the daily diary pain intensity score change (TONMYA 5.6 mg vs. placebo) from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores). Additional details on RELIEF (NCT04172831) and RESILIENT (NCT05273749) are available on clinicaltrials.gov.

RALLY was a replicate Phase 3 trial to RELIEF and RESILIENT that demonstrated greater but non-significant treatment effect with TONMYA compared to placebo and demonstrated consistent safety. Results of this trial may not have been generalizable due to the presence of factors outside the conduct of the study. Additional details are available on clinicaltrials.gov (NCT04508621).

Tonix Pharmaceuticals Holding Corp.
Tonix is a fully integrated, commercial-stage biotechnology company. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, infectious and rare diseases. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, MD. Tonix Medicines, Inc., a wholly owned commercial subsidiary, markets treatments for fibromyalgia and acute migraine.

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
Mary Ann Ondish
Tonix Pharmaceuticals
(862) 799-8599
investor.relations@tonixpharma.com

Brian Korb
astr partners
(917) 653-5122
brian.korb@astrpartners.com

Media Contact
Meagen Hagans
Weber Shandwick
(757)358-2033
MHagans@webershandwick.com

Merck to Acquire Cidara Therapeutics in $9.2 Billion Deal, Strengthening Its Antiviral Pipeline

Posted on by slightbourne@noblecapitalmarkets.com

Merck has announced a major expansion of its infectious disease portfolio with a definitive agreement to acquire Cidara Therapeutics, Inc. for approximately $9.2 billion. The all-cash transaction, valued at $221.50 per share, brings Cidara’s late-stage antiviral candidate CD388 directly into Merck’s pipeline as the company seeks to diversify its portfolio with innovative, long-acting preventative treatments.

The acquisition represents a strategic move for Merck, aligning with its long-standing approach of targeting high-impact scientific assets backed by strong development data. CD388, Cidara’s lead candidate, is considered one of the most promising antiviral innovations currently in development. Designed as a long-acting, strain-agnostic agent, CD388 aims to prevent infection from both influenza A and B, a significant advantage over seasonal vaccines that must be reformulated each year to match circulating strains.

CD388 combines a small-molecule neuraminidase inhibitor with Cidara’s proprietary drug-Fc conjugate (DFC) platform. This design is intended to provide durable protection against symptomatic influenza, particularly in groups most vulnerable to severe complications, such as older adults, cancer patients, and individuals with compromised immune systems.

The therapy is currently in the Phase 3 ANCHOR trial, following strong Phase 2b data in the NAVIGATE study, which demonstrated its effectiveness in preventing symptomatic, laboratory-confirmed influenza among unvaccinated adults. The U.S. Food and Drug Administration has recognized its potential through both Fast Track and Breakthrough Therapy designations, signaling the agency’s acknowledgment of the urgent need for more effective flu-prevention options.

For Merck, adding CD388 to its pipeline complements its existing respiratory portfolio and fills a critical unmet need at a time when influenza continues to cause significant global health burdens. Seasonal influenza leads to millions of infections each year and disproportionately affects high-risk populations. As viral strains evolve and vaccine hesitancy persists, demand for alternative prevention strategies continues to grow.

Cidara leadership characterized the acquisition as a transformative milestone. The company has dedicated its efforts to advancing DFC therapeutics and redefining how influenza can be prevented beyond traditional vaccines. With Merck’s global scale, regulatory strength, and commercial infrastructure, CD388 is positioned to reach markets internationally once approved.

The transaction has been unanimously approved by the boards of both companies. It will be executed through a tender offer by a Merck subsidiary, followed by a merger to acquire all outstanding Cidara shares. Completion of the deal remains subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act. Merck expects the acquisition to close in the first quarter of 2026, accounting for it as an asset acquisition on its financial statements.

With this deal, Merck reinforces its commitment to science-driven expansion and long-term growth, while Cidara gains the resources necessary to bring its innovative antiviral approach to patients worldwide. If successful, CD388 could become one of the most significant advancements in influenza prevention in more than a decade.

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

Posted on by aweinsoff@channelchek.com

Research News and Market Data on COCP

November 14, 2025

  • Received FDA IND clearance to evaluate CDI-988 as both norovirus preventive and treatment
  • Expects to initiate CDI-988 Phase 1b norovirus challenge study in Q1 2026
  • Granted NIH SBIR award to advance influenza A/B replication inhibitor program

BOTHELL, Wash., Nov. 14, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reports financial results for the three and nine months ended September 30, 2025, and provides updates on its antiviral product pipeline, upcoming milestones and business activities.

“We expect to begin enrolling participants in the first quarter of 2026 for our norovirus challenge study evaluating CDI-988, our oral broad-spectrum protease inhibitor,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “This study will provide an initial assessment of CDI-988 for both prevention and treatment of norovirus infection. Norovirus is a major cause of acute gastroenteritis and is highly contagious. It spreads rapidly in enclosed environments such as cruise ships, military bases, nursing homes, and hospitals. At present, there is no FDA-approved treatment or prevention for norovirus infection.

“We were honored to receive a Small Business Innovation (SBIR) award from the National Institutes of Health (NIH) to advance our work in developing a novel, broad-spectrum lead candidate targeting the influenza A/B polymerase complex,” added Dr. Lee. “This recognition further validates the strength of our structure-based drug discovery platform technology and its capability to develop innovative antiviral therapies for addressing unmet medical needs.”

“Together with the non-dilutive SBIR award, we strengthened our balance sheet through two recent at-the-market financings under Nasdaq rules,” said James Martin, Cocrystal’s CFO and co-CEO. “This enhanced cash position supports the continued development of our product pipeline, including our potentially groundbreaking norovirus program.”

In September 2025 Cocrystal raised gross proceeds of $4.7 million from a registered direct offering along with a private placement of warrants that, if fully exercised on a cash basis, will raise an additional $8.3 million. In October 2025, the Company completed a private placement with directors and management for gross proceeds of $1.03 million with warrants that, if fully exercised on a cash basis, will raise an additional $1.83 million.

Antiviral Product Pipeline Overview

We harness our revolutionary, structure-based drug discovery platform technology to engineer next-generation, broad-spectrum antivirals that precisely disrupt viral replication mechanisms. Unlike traditional approaches, our technology identifies compounds that bind to highly conserved regions of viral enzymes, thereby creating a formidable defense against current viral threats as well as their mutations. By specifically targeting these evolutionary-constrained viral regions, our drug candidates maintain efficacy even as viruses mutate, while simultaneously minimizing off-target interactions that typically lead to adverse side effects. This dual advantage represents a significant breakthrough in antiviral drug development. In addition, our innovative methodology fundamentally transforms the conventional drug discovery paradigm by eliminating the inefficient, resource-intensive cycles of high-throughput compound screening and prolonged hit-to-lead optimization. The result is faster identification of promising candidates with superior resistance profiles and safety characteristics.

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

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

  • Oral protease inhibitor CDI-988 for the treatment of noroviruses and coronaviruses
    • Our novel, broad-spectrum protease inhibitor CDI-988 is being evaluated as a potential treatment for noroviruses and coronaviruses.
    • CDI-988 has shown in vitro activity against multiple norovirus strains.
    • In May 2023 we announced approval of our application to the Australian regulatory agency for a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, tolerability and pharmacokinetics (PK) of CDI-988 in healthy subjects.
    • In August 2023 we announced our selection of CDI-988 as our lead compound for the treatment for noroviruses, in addition to coronaviruses.
    • In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study.
    • In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a high-dose cohort.
    • In April 2025 we announced that CDI-988 showed superior broad-spectrum antiviral activity against GII.17 strains, the most prevalent strain in the U.S. and Europe in 2024-2025.
    • In August 2025 we presented favorable safety and tolerability Phase 1 data from all CDI-988 doses, including the high-dose 1200 mg cohort, at the 2025 Military Health System Research Symposium (MHSRS).
    • In September 2025 we received a Study May Proceed Letter from the FDA to conduct a Phase 1b challenge study in the U.S. evaluating CDI-988 as a norovirus preventive and treatment.
    • Preparations are underway for the challenge study, with subject enrollment expected to begin in the first quarter of 2026.

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

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

  • Oral CC-42344 for the treatment of pandemic and seasonal influenza A
    • Our novel PB2 inhibitor CC-42344 showed excellent in vitro activity against pandemic and seasonal influenza A strains, as well as strains that are resistant to Tamiflu® and Xofluza®.
    • In December 2022 we reported favorable safety and tolerability results from the CC-42344 Phase 1 study.
    • In December 2023 we began a randomized, double-blind, placebo-controlled Phase 2a human challenge study to evaluate the safety, tolerability, viral and clinical measurements of CC-42344 in influenza A-infected subjects in the United Kingdom, following authorization from the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
    • In May 2024 we completed enrollment in the Phase 2a human challenge study.
    • In June 2024 we reported that in vitro studies demonstrated CC-42344 inhibits the activity of the highly pathogenic avian influenza A (H5N1) PB2 protein identified in humans exposed to infected dairy cows.
    • In December 2024 we announced a plan to extend the CC-42344 Phase 2a human challenge study due to unexpectedly low influenza infection among study participants.
    • In May 2025 we reported that CC-42344 was shown to be active against the highly pathogenic 2024 Texas H5N1 avian influenza strain.
    • In November 2025 our Phase 2a study was completed, with CC-42344 showing a favorable safety and tolerability profile with no serious adverse events (SAEs) and no drug-related discontinuations by study participants. Efficacy analyses were not reported due to issues in trial conduct.
    • We plan to continue development of oral CC-42344 as a treatment for pandemic and seasonal influenza A.
  • Inhaled CC-42344 as prophylaxis and treatment for pandemic and seasonal influenza A
    • Our preclinical testing showed superior pulmonary pharmacology with CC-42344, including high exposure to drug and a long half-life.
    • We have developed a dry powder inhalation formulation and have completed toxicology studies.
  • Influenza A/B program
    • In October 2025 we received a $500,000 SBIR Phase I award from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) to support the development of a novel, broad-spectrum lead candidate targeting the influenza A/B polymerase complex.

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

  • Oral protease inhibitor CDI-988 for the treatment of coronaviruses and noroviruses
    • CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and demonstrated a favorable safety profile and PK properties.
    • In September 2023 we dosed the first healthy subject in our norovirus/coronavirus CDI-988 study, which is expected to serve as a Phase 1 study for both indications.
    • In July 2024 we reported favorable safety and tolerability results from the single-ascending dose cohorts in the Phase 1 study.
    • In December 2024 we reported favorable safety and tolerability results from the multiple-ascending dose cohorts of the Phase 1 study and the addition of a high-dose cohort.
    • In August 2025 we presented favorable safety and tolerability Phase 1 data from all CDI-988 doses, including the high-dose 1200 mg cohort, at the MHSRS.

Third Quarter Financial Results

Research and development (R&D) expenses for the third quarter of 2025 were $954,000, compared with $3.2 million for the third quarter of 2024, with the decrease primarily due to the timing of clinical study costs as the trials started in 2024 were winding down in 2025. General and administrative (G&A) expenses for the third quarter of 2025 were $1.1 million, compared with $1.8 million for the third quarter of 2024, with the decrease primarily due to a reduction in compensation expense.

Net loss for the third quarter of 2025 was $2.0 million, or $0.19 per share, compared with a net loss for the third quarter of 2024 of $4.9 million, or $0.49 per share.

Nine Months Financial Results

R&D expenses for the first nine months of 2025 were $3.4 million, compared with $10.5 million for the first nine months of 2024. G&A expenses for the first nine months of 2025 were $3.1 million, compared with $4.1 million for the first nine months of 2024.

Net loss for the first nine months of 2025 was $6.4 million, or $0.61 per share, compared with a net loss for the first nine months of 2024 of $14.2 million, or $1.40 per share.

Cocrystal reported unrestricted cash as of September 30, 2025 of $7.7 million, which included $4.7 million in gross proceeds from a registered direct financing completed in September 2025, compared with $9.9 million as of December 31, 2024. Net cash used in operating activities for the first nine months of 2025 was $6.5 million, compared with $13.3 million for the first nine months of 2024. The Company had working capital of $7.3 million and 13.0 million common shares outstanding as of September 30, 2025.

In October 2025 Cocrystal was granted an NIH SBIR award for $500,000 and completed a private placement for $1.03 million in gross proceeds.

About Cocrystal Pharma, Inc.

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

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans for the future development of preclinical and clinical product candidates including the potential of our norovirus product candidates, our plans to initiate a human Phase 1b challenge study for our norovirus product candidate CDI-988 in early 2026, and our plans with regard to continued development of CC-42344, the potential characteristics and benefits of and market for our product candidates, and potential future capital we may receive from warrant exercises for cash. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from our need for additional capital to fund our operations and our ability to obtain such capital on favorable terms or at all, inflation, the possibility of a recession, interest rate increases, imposed and threated tariffs, and geopolitical conflicts including those in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., UK, Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations (CMOs), the progress and results of the studies including any adverse findings or delays, the ability of us and our CROs to recruit volunteers for, and to otherwise proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes and any adverse developments which may arise therefrom, potential mutations in a virus we are targeting that may result in variants that are resistant to a product candidate we develop, the potential for the development of effective treatments by competitors which could reduce or eliminate a prospective future market share commercializing any product candidates we may develop in the future, and our ability to meet our future liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

The Oncology Institute, Inc. (TOI) – Guidance Raised After 3Q25 Revenues Beat Expectations

Posted on by slightbourne@noblecapitalmarkets.com


Friday, November 14, 2025

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.

3Q25 Was A Strong Quarter. The Oncology Institute reported a loss of $16.5 million or $(0.14) per share, with revenues from Patient Services and Dispensary both ahead of our estimates. Adjusted EBITDA turned positive for the first time at the end of the quarter. Management raised guidance for Full-Year Revenues, and confirmed the ranges for Adjusted EBITDA, and Free Cash Flow. On September 30, the company had $27.7 million in cash.

Total Revenues Beat Our Estimates. Total Revenue of $136.6 million easily beat our estimate of $122.5 million. This was an increase from $119.8 million in 2Q25 (up 14%) and $99.9 million (up 37%) in 4Q24. Adjusted EBITDA of $(3.5) million was also better than the $(3.8) million we had estimated. COGS included a new reserve of $8.1 million for bad debts, lowering gross margin from 19.8% to 13.9% compared with the 15.2% we estimated.


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GeoVax Labs (GOVX) – 3Q25 Reported With Clinical Trial Updates and Plans To Move Products Forward

Posted on by slightbourne@noblecapitalmarkets.com


Friday, November 14, 2025

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as 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, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.

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.

Plans For MVA Vaccine and Gedeptin Trial Expectations Confirmed. GeoVax reported a 3Q25 loss of $6.3 million or $(0.31) per share, a smaller loss than the $8.0 million loss we had projected. The company reviewed several developments related to the Geo-MVA vaccine for smallpox/Mpox, Gedeptin, and CM04S1. Discussions for possible marketing collaborations continue. The cash balance on September 30, 2025 was $5.0 million.

Moving Forward With Geo-MVA. As discussed in our Research Note on June 17, the Geo-MVA vaccine for smallpox/Mpox is moving forward toward a Phase 3 trial. This follows receipt of Scientific Advice EMA (European Medicines Agency) stating that a marketing approval application can be submitted after a single, Phase 3 immuno-bridging study against the approved MVA vaccine. Phase 1 and Phase 2 would not be required. This saves several years and many millions dollars, allowing the company to sell the vaccine sooner.


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

Day One Biopharmaceuticals to Acquire Mersana Therapeutics in $285 Million Deal

Posted on by slightbourne@noblecapitalmarkets.com

Day One Biopharmaceuticals announced a definitive agreement to acquire Mersana Therapeutics (Nasdaq: MRSN), marking a strategic move to strengthen its position in oncology drug development. The deal, valued at up to $285 million, combines Day One’s commercial expertise with Mersana’s innovative antibody-drug conjugate (ADC) technology, expanding the company’s pipeline in targeted cancer therapies.

Under the terms of the agreement, Day One will acquire Mersana through a tender offer followed by a merger, offering $25 per share in cash upfront and up to $30.25 per share in additional contingent value rights (CVRs). The CVRs are tied to the achievement of specific clinical, regulatory, and commercial milestones, particularly related to Emi-Le (emiltatug ledadotin), Mersana’s B7-H4-directed ADC candidate. The total equity value at closing is estimated at $129 million, with the full deal potentially reaching $285 million if all milestones are met.

The acquisition highlights Day One’s intent to broaden its oncology focus beyond its current lead programs. Known for its commitment to developing therapies for pediatric and underserved cancer populations, Day One plans to leverage Mersana’s ADC platforms—Dolasynthen and Immunosynthen—to accelerate the development of next-generation cancer treatments.

For Mersana, the deal represents both validation and a strategic exit amid a challenging biotech funding environment. The company has been recognized for its innovative ADC technology, which delivers cytotoxic and immune-modulating agents directly to cancer cells, minimizing harm to healthy tissue. Its lead candidate, Emi-Le, is currently being explored for the treatment of triple-negative breast cancer and adenoid cystic carcinoma, both areas with high unmet clinical needs.

Upon completion of the acquisition, Mersana will become a wholly owned subsidiary of Day One, and its common stock will be delisted from public exchanges. The transaction is expected to close by the end of January 2026, subject to customary regulatory approvals and the tender of a majority of Mersana’s outstanding shares.

The merger agreement was unanimously approved by Mersana’s board of directors, which has recommended that shareholders tender their shares once the offer is formally launched. Key shareholders, including affiliates of Bain Capital Life Sciences, representing approximately 8.5% of outstanding shares, have already agreed to support the transaction.

Financially, TD Cowen is serving as Mersana’s advisor, while WilmerHale is acting as legal counsel. Fenwick & West LLP is representing Day One in the deal.

This acquisition aligns with broader industry trends in oncology, where partnerships and mergers are accelerating innovation in targeted therapies. ADCs have become one of the most promising drug classes in oncology, combining precision targeting with potent efficacy. The addition of Mersana’s technology could give Day One a competitive edge in developing more effective, tumor-specific treatments.

With closing anticipated early next year, the merger positions Day One Biopharmaceuticals as a growing force in precision oncology, combining innovative science with a mission-driven focus on expanding treatment options for patients of all ages battling cancer.

Release – GoHealth to Announce Third Quarter 2025 Results on November 13, 2025

Posted on by aweinsoff@channelchek.com

Research News and Market Data on GOCO

Nov 11, 2025 at 9:00 AM EST

CHICAGO, Nov. 11, 2025 (GLOBE NEWSWIRE) — GoHealth, Inc. (GoHealth) (NASDAQ: GOCO), a leading health insurance marketplace and Medicare-focused digital health company, announced that the company will release its third quarter 2025 financial results on the morning of November 13, 2025.

Chief Executive Officer, Vijay Kotte, and Chief Financial Officer, Brendan Shanahan, will host a conference call and live audio webcast on the day of the release at 8:00 a.m. (ET) to discuss the results.

A live audio webcast of the conference call will be available via GoHealth’s Investor Relations website, https://investors.gohealth.com/. A replay of the call will be available via webcast for on-demand listening shortly after the completion of the call.

About GoHealth, Inc.

GoHealth is a leading health insurance marketplace and Medicare-focused digital health company whose purpose is to compassionately ensure consumers’ peace of mind when making healthcare decisions so they can focus on living life. For many of these consumers, enrolling in a health insurance plan is confusing and difficult, and seemingly small differences between health plans may lead to significant out-of-pocket costs or lack of access to critical providers and medicines. GoHealth’s proprietary technology platform leverages modern machine-learning algorithms, powered by over two decades of insurance purchasing behavior, to reimagine the process of matching a health plan to a consumer’s specific needs. Its unbiased, technology-driven marketplace coupled with highly skilled licensed agents has facilitated the enrollment of millions of consumers in Medicare plans since GoHealth’s inception. For more information, visit https://www.gohealth.com.

Investor Relations
John Shave
jshave@gohealth.com

Media Relations
Pressinquiries@gohealth.com

Cadrenal Therapeutics (CVKD) – 3Q25 Reported With Product Pipeline Updates

Posted on by slightbourne@noblecapitalmarkets.com


Tuesday, November 11, 2025

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.

Cadrenal Made A Significant Acquisition In 3Q25. Cadrenal reported a loss of $2.7 million or $(1.31) per share, less than the loss of $3.1 million we estimated. The company also provided an update on clinical progress for tecarfarin and the products acquired through the recent acquisition of eXithera Therapeutics. At the end of the quarter on September 30, the company had cash on hand of $3.9 million.

Tecarfarin Is Making Clinical Progress. During the quarter, the company continued to support the Phase 2 trial in LVAD (left ventricular assist devices) as part of its collaboration with Abbott. Separately, it also continued its consultations with Clinical Investigators to design a Phase 2 trial in dialysis patients previously treated with warfarin. The manufacture of tecarfarin supplies for clinical trials that comply with the FDA’s Good Manufacturing Practices (cGMP) was also completed.


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

The Beachbody Company (BODI) – Turnaround Ahead of Schedule

Posted on by slightbourne@noblecapitalmarkets.com


Tuesday, November 11, 2025

Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.

Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.

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

Solid Q3 Results. The company reported Q3 revenue of $59.9 million and adj. EBITDA of $9.5 million, both of which surpassed our estimates of $54.0 million and $2.6 million, respectively, as illustrated in Figure #1 Q3 Results. Additionally, the strong results surpassed the high end of company issued guidance, of $51.0 million to $58.0 million in revenue and $2.0 million to $6.0 million in adj. EBITDA. Furthermore, the company hit an important milestone, recording net income for the first time since going public.

Improved operating structure. Over the past several years, the company has significantly lowered its break-even point from $900 million in 2022 to $180 million in 2025, largely through SG&A optimization and the elimination of Multi Layer sales costs. The new model offers enhanced operating leverage, enabling profitability at lower revenue levels and providing a favorable outlook ahead of several new product releases.


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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.

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