Tag: Biotech

Release – Tonix Pharmaceuticals Announces Positive Pre-IND Meeting with FDA for TNX-102 SL for the Treatment of Major Depressive Disorder

Posted on by slightbourne@noblecapitalmarkets.com

CHATHAM, N.J., Sept. 18, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced the successful completion of a Type B Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of TNX-102 SL (sublingual cyclobenzaprine HCl) for the treatment of major depressive disorder (MDD). The Company received positive feedback from the FDA and plans to pursue a supplemental new drug application (sNDA) to expand the therapeutic indication of TNX-102 SL to include MDD, based on exploratory findings suggesting that improving sleep quality may positively impact depressive symptoms.

“We are pleased with the outcome of our Pre-IND meeting with the FDA and appreciate their thoughtful guidance,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “This marks a significant step forward in our efforts to develop TNX-102 SL as a novel treatment for MDD, a condition that affects millions and remains underserved by current therapies that are often difficult to tolerate.”

“We believe bedtime TNX-102 SL has the potential to be a first-in-class treatment that is designed to target the reduced quality and quantity of slow wave sleep associated with depression,” said Dr. Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “TNX-102 SL is a tertiary amine tricyclic that is designed for transmucosal absorption to bypass first pass hepatic metabolism. In contrast, FDA-approved tertiary amine tricyclic antidepressants are swallowed pill formulations, that are largely metabolized by first-pass to longer-lived secondary amine tricyclics. Also, the FDA-approved tertiary amine tricyclic antidepressants are only active in treating MDD at more than ten times the dose employed with TNX-102 SL and can adversely impact weight, blood pressure, cognition, and sexual function.”

The FDA provided constructive feedback during the Pre-IND meeting for TNX-102 SL in MDD and found the proposed long-term safety data collection plan generally reasonable, potentially streamlining the development path.

An IND filing is planned for Q4 2025, positioning the program to enter Phase 2 clinical trials shortly thereafter. TNX-102 SL is FDA approved for the treatment of fibromyalgia, under the brand name Tonmya™. In the Phase 3 RESILIENT study of fibromyalgia patients, the TNX-102 SL – treated group had activity on improving depression over placebo by the Beck Depression Inventory (BDI), with an uncorrected p-value < 0.05. The biological relationship between depressed symptoms in fibromyalgia and those in MDD is not understood.

About TNX-102 SL
TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride that enables rapid transmucosal absorption and reduces production of the long half-life active metabolite, norcyclobenzaprine, by bypassing 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. It is currently approved in the U.S. as a once-daily bedtime treatment for fibromyalgia in adults. TNX-102 SL is also in development as a daily bedtime treatment for acute stress reaction/acute stress disorder. Tonix also holds active IND’s for the following indications for TNX-102 SL: Long COVID (post-acute sequelae of COVID-19), PTSD, alcohol use disorder, and agitation in Alzheimer’s disease. 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.

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™, 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 and infectious diseases. 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 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 failure to successfully launch and commercialize Tonmya and any of our approved products; 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 Contact
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

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

Media Contact
Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

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.

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Source: Tonix Pharmaceuticals Holding Corp.

Release – Greenwich LifeSciences Announces Expansion of Flamingo-01 Clinical Trial to Ireland

Posted on by slightbourne@noblecapitalmarkets.com

Sept. 18, 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 Ireland.

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

According to the latest data collected by the European Cancer Information System (click here), a total of 3,723 new cases of breast cancer were diagnosed in Ireland in 2022, which is the most common cancer diagnosed in women, representing approximately 30% of all cancers in women. Breast cancer is the 2nd leading cause of death from cancer in women in Ireland with 883 deaths in 2022.

The Company is collaborating with Dr. Janice Walshe, who will be serving as the national principal investigator in Ireland for FLAMINGO-01. She is a key member of Cancer Trials Ireland research group ensuring access to novel agents and research opportunities for Irish women affected by breast cancer. Through the clinical research clinic in St Vincent’s University Hospital in Dublin, Ireland, she has served as national principal investigator for many important international trials in breast cancer. She served as a three-year member of ASCO Scientific Program Committee in triple negative breast cancer from 2013-2015. Her research has been presented at numerous international meetings and published in prestigious peer reviewed journals.

CEO Snehal Patel commented, “We have visited St. Vincent’s multiple times over the past few years, once to present GP2 and FLAMINGO-01 at their conference and most recently to train the study team. We have also been approached by Irish breast cancer patients who wish to participate in FLAMINGO -01 and who can now be considered for enrollment through the Dublin site.”

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: flamingo-01@greenwichlifesciences.com

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: info@greenwichlifesciences.com

Investor & Public Relations Contact for Greenwich LifeSciences
Dave Gentry
RedChip Companies Inc.
Office: 1-800-RED CHIP (733 2447)
Email: dave@redchip.com

Source: Greenwich LifeSciences, Inc.

Roche to Acquire 89bio in $3.5 Billion Deal to Advance MASH Treatment Pipeline

Posted on by slightbourne@noblecapitalmarkets.com

Swiss pharmaceutical leader Roche has announced an agreement to acquire clinical-stage biopharmaceutical company 89bio, Inc. in a deal valued at up to $3.5 billion. The acquisition is set to strengthen Roche’s cardiovascular, renal, and metabolism portfolio, particularly its capabilities in treating metabolic dysfunction-associated steatohepatitis (MASH).

Under the terms of the agreement, 89bio shareholders will receive $14.50 per share in cash at closing, along with a non-tradeable contingent value right (CVR) providing up to an additional $6.00 per share contingent on specific milestones. The CVR payments are linked to the commercial success and sales performance of 89bio’s lead candidate, pegozafermin, a novel fibroblast growth factor 21 (FGF21) analog designed for patients with moderate to severe MASH and severe hypertriglyceridemia.

Pegozafermin is currently in Phase 3 clinical trials and is engineered to provide extended biological activity through a proprietary glycoPEGylated technology. The therapy aims to address critical unmet medical needs in liver and cardiometabolic diseases, including patients with advanced fibrosis and compensated cirrhosis. Its potential best-in-disease profile makes it a significant addition to Roche’s portfolio, enhancing the company’s efforts to provide innovative treatment options to patients worldwide.

The contingent payments under the CVR are structured to reward milestone achievements, including the first commercial sale of pegozafermin in F4 MASH cirrhotic patients, and annual global sales thresholds of $3 billion and $4 billion in subsequent years. This structure aligns shareholder incentives with the commercial success of the therapy while reflecting the high growth potential of 89bio’s pipeline.

The acquisition is subject to customary closing conditions, including the tender of a majority of 89bio’s outstanding shares and regulatory approvals. Roche plans to complete the transaction in the fourth quarter of 2025, after which 89bio will become part of Roche’s Pharmaceuticals Division. Until the closing, 89bio will continue to operate independently, maintaining its focus on the development of innovative therapies for liver and cardiometabolic diseases.

Financial advisors for 89bio include Moelis & Company LLC and Centerview Partners LLC, with Gibson, Dunn & Crutcher LLP serving as legal counsel. Citi and Sidley Austin LLP act as Roche’s financial and legal advisors.

The acquisition positions Roche to potentially transform the standard of care for patients with metabolic liver diseases while leveraging 89bio’s advanced clinical pipeline. Analysts view the deal as a strategic move to capture emerging opportunities in high-growth therapeutics, combining 89bio’s innovative platform with Roche’s global development, manufacturing, and commercialization capabilities.

Gyre Therapeutics, Inc (GYRE) – Positioned To End YE2025 With Strong Products and Pipeline Development

Posted on by slightbourne@noblecapitalmarkets.com


Tuesday, September 09, 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.

Gyre Has Made Strong YTD Progress. Gyre has made significant progress during the first three quarters of FY2025 that we believe positions the company for a strong year-end. These developments include continued sales growth from two products introduced in 1H25, an application for Hydronidone approval in China, and the start of a Phase 2 clinical trial for Hydronidone in the US. The company also announced the appointment of Dr. Han Ying as the new CEO, a member of the Board of Directors since January 2025.

Hydronidone Data Showed Efficacy and Proof of Concept. The pivotal Phase 3 trial testing Hydronidone in Chronic Hepatitis B-associated fibrosis has met its primary endpoint of fibrosis regression. The study was conducted in China, and an application for approval by the NMPA (the Chinese regulatory authority) is planned for 3Q2025. Hydronidone has received Breakthrough Therapy Designation, allowing for accelerated review. We expect approval in 2H2026, followed by launch in FY2027.


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

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

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

Unicycive Therapeutics (UNCY) – Actions Taken To Address Issues That Caused The CRL

Posted on by slightbourne@noblecapitalmarkets.com


Friday, August 15, 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.

Actions Taken To Correct Manufacturing Findings. Unicycive reported a 2Q25 loss of $6.4 million or $(0.52) per share, with cash on June 30, 2025 of $22.3 million. Based on our current estimates, we believe this is sufficient to fund operations through 2H25. On June 30, the company received a CRL (Complete Response Letter) following an FDA inspection that found deficiencies at a contract manufacturer’s facility. The findings stopped the labeling discussions required for completion of the NDA review. The company has shifted to one of its other manufacturers, and filed a request for a meeting with the FDA. 

A Request For A Type A Meeting Was Filed. Following the receipt of the CRL, Unicycive filed a request for a Type A meeting with the FDA. This type of meeting is held to discuss the issues that led to the CRL and how to correct them. These meetings are usually scheduled within 30 days of the request. After meeting is held the company will receive the meeting minutes with requirements for resubmission of the NDA application. Unicycive expects to announce an updated plan for OCL development during 3Q25.


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

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

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

Cadrenal Therapeutics (CVKD) – 2Q25 Included Clinical Strategy Change and Manufacturing Progress

Posted on by slightbourne@noblecapitalmarkets.com


Tuesday, August 12, 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 Reports 2Q With Product News. Cadrenal reported a 2Q25 loss of $3.7 million or $(1.87) per share. During the quarter, the company announced a design modification for the upcoming tecarfarin clinical trial. The company also transferred its manufacturing technology to a CDMO and completed production scale-up in preparation for clinical trials. Cash on June 30, 2025 was $5.6 million.

New Trial Focuses On First Months Of Dialysis. As described in our Research Note on August 7 , the new trial design reflects recent research showing the first four to six months after the start of renal dialysis are an ultra-high-risk period for cardiac events including myocardial infarction, stroke, embolism, and death. The design change will be testing tecarfarin as an anticoagulant to reduce these events. The clinical site activation and trial enrollment are expected to begin around year-end.


Get the Full Report

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

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

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

Eledon Pharmaceuticals (ELDN) – Phase 1b Data Continues To Show Improved Outcomes

Posted on by slightbourne@noblecapitalmarkets.com


Thursday, August 07, 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.

Phase 1b Kidney Transplant Data Presented. Eledon presented data from its Phase 1b trial using tegoprubart as part of an immunosuppressive regimen at The World Transplant Congress. The data from the first 32 patients at two dosage cohorts continues to show meaningful improvement over the standard of care. We believe this supports our expectations for strong data for the Phase 2 BESTOW trial in November.

Study Design. The presentation included data from 32 patients receiving kidney transplants followed by an immunosuppressive regimen tegoprubart instead of tacrolimus, the standard of care. The primary endpoints are safety and pharmacokinetics. Secondary endpoints include patient survival, graft survival, biopsy proven acute rejection, with kidney function measured by eGFR and iBOX score.


Get the Full Report

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

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

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

Ocugen (OCGN) – 2Q25 Reported With All Three Trials On Schedule

Posted on by slightbourne@noblecapitalmarkets.com


Monday, August 04, 2025

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

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.

Product Updates All Three Trials Are On Schedule. Ocugen reported a 2Q25 loss of $14.7 million or $(0.05) per share. During the quarter, the clinical trials made progress to keep the products on schedule for 3 BLA filings beginning in 2026. The quarter also included a licensing agreement covering OCU400 in South Korea and the reverse merger to form OthroCellix, a new company focused on regenerative medicine.

OrthoCellix Has Been Formed To Develop NeoCart. Ocugen and Carisma Therapeutics, Inc. announced a reverse merger that will create a new company developing regenerative cellular therapies.  As discussed in our Research Note on June 24, NeoCart  cellular therapy is outside its main focus. The transaction is expected to close in September-October with the new company valued at $150 million. The Phase 3 pivotal trial is expected to begin in FY2025.


Get the Full Report

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

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

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

GeoVax Labs (GOVX) – 2Q25 Reported With MVA and Gedeptin Trial Updates

Posted on by slightbourne@noblecapitalmarkets.com


Tuesday, July 29, 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.

GeoVax Reports 2Q25 Financials With Updates Trials For MVA and Gedeptin. GeoVax reported a 2Q25 loss of $5.4 million or $(0.35) per share. Revenues of $0.9 million were for work performed under the BARDA contract prior to its cancellation in April 2025. During the quarter, the EMEA communicated that the GEO-MVA vaccine in development for smallpox/Mpox could skip Phase 1 and 2, then receive approval based on Phase 3 immune markers. The company also amended its trial plans for Gedeptin in HNSCC.

GEO-MVA Phase 3 Is Expected To Begin In 2H26. As discussed in our Research Note on June 17,GeoVax received Scientific Advice (SA) from the EMA for GEO-MVA smallpox/Mpox vaccine stating the Phase 1 and 2 studies would not been needed. An MAA will only require a single Phase 3 immuno-bridging trial comparing the immune response in healthy volunteers receiving GEO-MVA against the approved vaccine. The study is expected to begin in 2H26.


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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. 

Zimmer Biomet Acquires Monogram Technologies to Lead in Robotic Orthopedics

Posted on by slightbourne@noblecapitalmarkets.com

Zimmer Biomet (NYSE: ZBH), one of the world’s leading medical technology companies, announced a definitive agreement to acquire Monogram Technologies (NASDAQ: MGRM), a fast-growing robotics innovator, in a strategic move that could redefine the future of orthopedic surgery. The $177 million all-cash deal includes an upfront payment of $4.04 per share and a potential additional $12.37 per share via a non-tradeable contingent value right (CVR), contingent on milestones through 2030.

The acquisition marks a major milestone in Zimmer Biomet’s mission to deliver a next-generation surgical robotics platform. Monogram brings proprietary semi- and fully autonomous robotic systems designed for total knee arthroplasty (TKA), bolstered by FDA clearance in early 2025. The deal also positions Zimmer Biomet to be the first company in orthopedics to offer a fully autonomous surgical robot—a potential game-changer in an increasingly tech-driven sector.

Zimmer Biomet’s existing ROSA® Robotics platform already leads in imageless robotics and is nearing 2,000 global installations. By integrating Monogram’s AI-driven, CT-based surgical systems, the company expands its portfolio to address varying surgeon preferences—manual, semi-autonomous, or fully autonomous—and across different anatomical procedures.

This acquisition gives Zimmer Biomet a first-mover advantage in the race for orthopedic robotics innovation. With Monogram’s platform, the company aims to deliver safer, more efficient surgeries and drive adoption across hospitals and ambulatory surgery centers (ASCs) seeking digital and robotic enhancements.

Monogram’s technology complements Zimmer Biomet’s current development pipeline, including ROSA Knee with OptimiZe, ROSA Posterior Hip, and ROSA Shoulder—key components of its multi-year plan to remain the global leader in orthopedic robotics.

Financially, the acquisition is expected to be neutral to Zimmer Biomet’s adjusted earnings per share through 2027 and accretive thereafter. Management projects high-single-digit returns on invested capital by year five, fueled by accelerated robotic knee adoption, greater share of wallet, and broader customer reach in the U.S. and internationally.

Tariffs and broader market volatility have weighed on the healthcare sector in 2025, but Zimmer Biomet’s move signals a long-term, innovation-led growth strategy. By enhancing its robotics suite, the company is positioning itself to capture demand in one of the fastest-growing medtech segments.

With regulatory approval and Monogram shareholder consent still pending, the merger is expected to close later this year. Once complete, Zimmer Biomet will be uniquely positioned with the industry’s most flexible and comprehensive orthopedic robotics ecosystem.

This acquisition isn’t just a strategic bolt-on; it’s a forward-looking bet on where surgery is headed—autonomous, data-driven, and personalized. For investors seeking exposure to the convergence of AI, robotics, and healthcare, Zimmer Biomet’s expanding portfolio offers a compelling case for long-term value creation.

Eledon Pharmaceuticals (ELDN) – Meeting Highlights Tegoprubart Data Milestones and New Indications

Posted on by slightbourne@noblecapitalmarkets.com


Thursday, July 10, 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.

R&D Day Highlighted Science, Current Trials, Future Indications. We attended the Eledon R&D Day on July 9 to hear and evaluate the progress in tegoprubart development. The presentations focused on the current clinical indications in renal transplantation, islet cell transplantation, xenotransplants, and plans for liver and other solid organ transplants. Conference presentation dates for upcoming data announcements were also announced.

Phase 1b Data Update Is Planned For August. The Phase 1b open-label trial has been expanded to enroll up to 36 patients, an increase from the original 9 patients. Data is scheduled for presentation at the World Transplant Congress on August 9, 2025. Previous data presentations have included 13 patients. We expect to see follow-up data from more patients treated longer, with data from additional patients beyond the initial 12-month trial duration.


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

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

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

XOMA Acquires Turnstone in $0.34 Per Share Deal with Future Payouts

Posted on by slightbourne@noblecapitalmarkets.com
Key Points:
– XOMA will acquire Turnstone for $0.34 per share plus a CVR.
– 25.2% of shareholders have agreed to the deal.
– The acquisition expands XOMA’s biotech royalty portfolio.

In a notable development in the biotech investment landscape, XOMA Royalty Corporation has entered into a definitive agreement to acquire Turnstone Biologics Corp. in a cash and contingent value right (CVR) transaction. The acquisition underscores XOMA’s continued push to expand its royalty and milestone-driven portfolio by targeting biotech firms with high-risk, high-reward therapeutic assets.

Under the terms of the deal announced June 27, XOMA Royalty will pay $0.34 per share in cash to Turnstone shareholders, along with a non-transferable CVR tied to future clinical or commercial milestones. The transaction was unanimously approved by Turnstone’s board following a comprehensive strategic review, indicating strong alignment between both companies on the benefits of the proposed merger.

The transaction will be executed through a tender offer, which XOMA is expected to launch by July 11, 2025. To move forward, the offer requires acceptance by holders representing at least a majority of Turnstone’s outstanding shares, along with other standard closing conditions including a minimum cash balance at the time of closing.

Significantly, shareholders representing roughly 25.2% of Turnstone’s stock have already agreed to support the deal and tender their shares, increasing the likelihood of a successful outcome. If the tender offer is completed as planned, remaining shares not tendered—excluding any subject to appraisal rights—will be converted into the same cash and CVR terms. The full acquisition is anticipated to close by August 2025.

The CVR element of the deal provides Turnstone shareholders with potential upside depending on the progress of its pipeline, which historically has focused on Selected Tumor-Infiltrating Lymphocyte (Selected TIL) therapy for the treatment of solid tumors. While the company has faced challenges in recent quarters, its research has positioned it within a promising niche of the immuno-oncology space.

Turnstone has partnered with Leerink Partners as financial advisor and Cooley LLP for legal counsel during the transaction process. On the acquiring side, XOMA is represented by legal firm Gibson, Dunn & Crutcher LLP.

This acquisition adds another layer to XOMA’s unique business model, which focuses on purchasing future economic rights—royalties and milestone payments—from pre-commercial and commercial biotech programs. These rights are typically tied to therapies developed and licensed out by smaller biotech companies to larger pharmaceutical firms. In return, the selling firms receive non-dilutive capital they can reinvest into pipeline development or general operations.

By bringing Turnstone into its fold, XOMA potentially gains exposure to novel cancer therapies while giving Turnstone a viable financial exit at a time when biotech funding remains tight. The CVR component allows existing shareholders to benefit from any future success tied to Turnstone’s core scientific work, creating a hybrid payout structure aligned with both short-term liquidity and long-term optionality.

The transaction reflects a growing trend in biotech M&A, where royalty aggregators like XOMA leverage strategic acquisitions to build long-term value while offering capital relief to development-stage firms.

As of now, both companies remain focused on a smooth closing process, with investors watching closely to see how Turnstone’s science and XOMA’s model will align in the quarters ahead.

Ocugen (OCGN) – Merger Agreement Moves NeoCart Into A New Company

Posted on by slightbourne@noblecapitalmarkets.com


Tuesday, June 24, 2025

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

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.

NeoCart Transferred To Form New Regenerative Medicine Company. Ocugen has announced that it has entered into a merger agreement with Carisma Therapeutics to form a new company. Ocugen will transfer its wholly-owned regenerative medicine division, OrthoCellix, including NeoCart, an autologous cartilage implant technology that uses a patient’s cells to repair articular cartilage defects in the knee. The all-stock transaction is valued at $150 million, with Ocugen shareholders owning 90% of the new company.

We Expect The New Company To Accelerate NeoCart Development. Ocugen has been refining the Phase 3 trial design and has planned to start Phase 3 trials during FY2025. NeoCart has received Regenerative Medicine Advanced Therapy (RMAT) designation, which accelerates BLA review and could lead to faster approval. While the NeoCart data has been strong, NeoCart was a legacy product that was acquired by Ocugen as part of its 2019 reverse merger with Histogenics. Regenerative medicine is outside Ocugen’s main focus, and we believe it can be developed more rapidly by a company focused on regenerative medicine.


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

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

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