Category: Healthcare

Tonix Pharmaceuticals Announces Publication of Phase 1 Clinical Data of TNX-1500, an Fc-Modified anti-CD40L (CD154) Monoclonal Antibody, in the Peer-Reviewed Journal of Clinical Immunology

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May 27, 2026 7:00am EDT

Phase 1 data support TNX-1500 as a potentially first-in-class, best-in-class, third-generation anti-CD40L monoclonal antibody for the prevention of kidney transplant rejection

Phase 2 investigator-initiated study in adult kidney transplant at Massachusetts General Hospital (MGH) expected to initiate in the 2nd half of 2026 pending U.S. Food and Drug Administration (FDA) clearance of MGH’s Investigational New Drug (IND) application

BERKELEY HEIGHTS, N.J., May 27, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial-stage biotechnology company, today announced the publication of a paper, “First-in-Human, Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of TNX-1500, an Fc-Modified anti-CD154 Monoclonal Antibody, Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses in Healthy Adults,” in the peer-reviewed Journal of Clinical Immunology. TNX-1500 is an investigational, third-generation Fc-modified IgG4 anti-CD40L (also known as CD154) monoclonal antibody (mAb) in development for the prevention of organ transplant rejection and the treatment of autoimmune diseases. The manuscript can be accessed at https://pubmed.ncbi.nlm.nih.gov/42053701/.

“The CD40L is a validated target for preventing organ rejection in transplant and treating autoimmune disease, yet no anti-CD40L mAb has been approved for any indication,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TNX-1500 is a Phase 2 ready humanized mAb engineered to improve safety and tolerability relative to first-generation anti-CD40L mAbs, while preserving the durable half-life and certain effector functions associated with the Fc or crystallizable fragment. We believe the Phase 1 results show that these design objectives were achieved in TNX-1500.”

Dr. Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals added, “The Phase 1 study evaluated TNX-1500’s safety, tolerability, pharmacokinetics, and pharmacodynamics. TNX-1500 was generally well tolerated, demonstrated a favorable safety profile, suppressed the primary and secondary T cell-dependent antibody responses (TDARs) to keyhole limpet hemocyanin (KLH) antigen, and showed a half-life which supports monthly intravenous dosing. We expect a Phase 2, investigator-initiated study of TNX-1500 in the prevention of kidney allograft rejection at MGH to begin in the 2nd half of 2026 pending clearance of the IND by the FDA.”

The publication reports findings from a single-center, first-in-human, Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose escalation study in 26 healthy adult volunteers. Participants were enrolled across three ascending dose cohorts (3, 10, and 30 mg/kg) or placebo and received a single intravenous infusion of TNX-1500 or placebo, followed by intramuscular injections of KLH on days 2 and 29 to assess the TDAR, and monitored over a 120-day follow-up period. TNX-1500 blocked the primary T cell–dependent antibody response to KLH at all doses, blocked the secondary response at the 10 and 30 mg/kg doses, and reduced peak secondary response to KLH by ~70% relative to placebo at the 3 mg/kg dose.

TNX-1500 was generally well tolerated, with no serious adverse events, and no discontinuations due to adverse events. The only treatment-emergent adverse event (TEAE) deemed possibly related to study drug was aphthous ulcer, which occurred in 1 participant in each of the three TNX-1500 groups; all TEAEs were rated as mild and resolved in 2-10 days. No TEAEs were determined to be related to KLH administration. There were no administration or injection site reactions (one of the prespecified TEAEs of special interest). Pharmacokinetic analyses suggested approximately dose-proportional exposure across the 3 to 30 mg/kg range, with mean terminal elimination half-lives of 37.8 and 33.8 days at the 10 and 30 mg/kg dose levels, respectively. TNX-1500 at 10 and 30 mg/kg blocked the primary and secondary anti-KLH TDAR through day 120, and at 3 mg/kg reduced the peak secondary response by approximately 70% relative to placebo. Across all dose cohorts, TNX-1500 was associated with a rapid (less than one-hour post-dose) and sustained reduction in soluble CD40L (sCD154) over the 120-day study period.

About TNX-1500

TNX-1500 (Fc-modified humanized anti-CD40L mAb) is a Phase 2 ready, humanized monoclonal antibody that interacts with the CD40-ligand (CD40L), also known as CD154. TNX-1500 is being developed for the prevention of kidney transplant rejection and the treatment of autoimmune diseases. Anti-CD40L has multiple potential indications in addition to solid organ and bone marrow transplantation including autoimmune diseases. Collaborations are ongoing with MGH on allo-heart and -kidney transplantation in nonhuman primates, as well as prevention of xenograft rejection, preclinical studies, and prevention of allograft rejection in sensitized patients. The Phase 2 investigator-initiated study by MGH is expected to initiate enrollment in the 2nd half of 2026, pending FDA clearance of the IND, to evaluate TNX-1500 in five kidney transplant recipients. The study is designed to assess the safety, tolerability, and activity of TNX-1500 in preventing kidney transplant rejection while decreasing the exposure to conventional immunosuppressive drugs, which are associated with infection, cancer, cardiovascular side effects, and various metabolic derangements with long term use.

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) disorders, infectious diseases, immunology conditions, and rare diseases where there exists high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s flagship internally conceived and developed medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is extending the science behind TONMYA in Phase 2 clinical studies to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including monoclonal antibody TNX-4800 (anti-OspA mAb) for Lyme disease prevention in the U.S. and TNX-801 (horsepox, live virus vaccine), a vaccine in development for the prevention of mpox and smallpox. Within immunology, Tonix is developing TNX-1500 (anti-CD40L mAb), a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. Finally, the Company’s rare disease portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome. To learn more, visit www.tonixpharma.com.

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

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

Forward Looking Statements

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

Investor Contacts

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

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

Media Contacts

Deborah Elson
Tonix Pharmaceuticals
[email protected]

Ray Jordan
Putnam Insights
[email protected]

Source: Tonix Pharmaceuticals Holding Corp.

GeoVax Labs (GOVX) – Development To Focus On Best Opportunities In Infectious Disease and Oncology

Posted on by [email protected]


Wednesday, May 27, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Resources To Focus On Current Market Needs. GeoVax has reviewed its pipeline products in infectious disease and oncology programs. Preparations will continue for the Phase 3 immunobridging trial in Mpox, expected to begin later this year.  A Phase 2 for Gedeptin is planned for FY2027. Development of CM-04S1 has been terminated, as the diminished need for a vaccine to protect immunocompromised patients from COVID-19 no longer justifies its continuation.

GEO-MVA and Infectious Diseases Remain A Priority. As discussed in our Research Note on May 19, 2026, GeoVax is preparing for a Phase 3 immunobridging trial in Mpox that could meet EMA requirements for accelerated approval. The trial is expected to begin in 2H26 with a planned enrollment of about 500 participants. The preclinical pipeline includes products for other infectious viruses that could be developed if grant or other funding were available.


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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. 

Cocrystal Pharma (COCP) – Technology Platform Has Novel Therapeutics Against Hantavirus, Bunyavirus, and Influenza

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Wednesday, May 27, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Proprietary Technology Has Produced A Large Library Of Novel Antivirals. Cocrystal has developed a library of antivirals based on its proprietary technology. While clinical development has prioritized products with clear medical needs and regulatory pathways to approval, it continues to research new compounds that can be moved into development as public health needs change. After the recent outbreaks of hantavirus, Ebola, and several previously lesser-known viruses, the company tested some of these compounds and found them to be effective.

Cocrystal’s Proprietary Technology Acts Early In The Viral Lifecycle. Cocrystal drugs target enzymes essential to the viral life cycle and reproductive process. These enzymes are highly conserved across viral families and rarely mutate, allowing compounds to show broad efficacy against multiple strains. This differs from vaccines that train the immune system to recognize and kill a virus. Vaccines often target surface proteins that can mutate, rendering the vaccine ineffective.


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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. 

Release – Tonix Pharmaceuticals Presented Retrospective U.S. Real-World Claims Analysis Characterizing Patients with Fibromyalgia at The Professional Society for Health Economics and Outcomes Research (ISPOR) 2026 Annual Meeting

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May 26, 2026 7:00am EDTDownload as PDF

Real-world analysis of three years of closed claims data from Symphony Health focused on the third year of the study (2023-2024), comprised of more than 261,000 U.S. adults with fibromyalgia

Data underscore high comorbidity burden, multimodal treatment approach, and extensive healthcare resource utilization (HCRU) among patients with fibromyalgia

Tonix commercially launched TONMYA® in November 2025, the first new fibromyalgia drug for adults in the U.S. approved in over 15 years

BERKELEY HEIGHTS, N.J., May 26, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, presented data from a real-world claims analysis characterizing U.S. adults with fibromyalgia in a poster at ISPOR 2026, the Professional Society for Health Economics and Outcomes Research’s annual meeting, held May 17-20, 2026, in Philadelphia, Pennsylvania.

“Fibromyalgia is a chronic pain disorder characterized by widespread musculoskeletal pain, fatigue, sleep disturbance, cognitive dysfunction, and somatic symptoms, leading to substantial management challenges,”1-4 said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “More than 10 million adults in the U.S. suffer from fibromyalgia. In response to fibromyalgia’s complex and persistent symptoms, and extensive comorbidities, fibromyalgia patients face rotating treatment approaches, and high HCRU. These findings highlight the need for comprehensive disease management and more effective therapeutic interventions to reduce the clinical and economic burden of fibromyalgia. Tonix is focused on the commercial launch of TONMYA, a first-in-class, first-line, non-opioid analgesic medicine designed for daily bedtime administration and long-term use.”

Data presented at ISPOR 2026 represent a retrospective, multi-year, multi-cohort study using the Symphony Health closed claims database, encompassing administrative medical and pharmacy claims collected between April 2021 and April 2024. The study’s objective was to evaluate real-world characteristics, including demographics, comorbidities, and HCRU among adults diagnosed with fibromyalgia (ICD-10-CM diagnosis code M79.7). The Year 3 cohort (April 2023 to March 2024) included 261,776 adult patients, with a median age of 53 years. Most patients were female (92.1%). Patients were White non-Hispanic (49.6%), Hispanic (22.4%), Other (19.6%), and Black (8.3%).

Comorbidity burden was high, with 93.2% of patients having at least one fibromyalgia-related comorbidity, most commonly anxiety/depression (63.9%), dorsalgia/back pain (56.5%), hypertensive diseases (51.4%), and joint pain (48.4%). Among the 90.3% of patients with at least one co-existing condition (or comorbidity), 36.2% had four or more, and subgroups including Black/Brown women, women on opioids, women with gut health issues, and older women with sleep issues all carried higher rates of comorbidity than the overall cohort. Among insured patients (n=92,157), HCRU was extensive, and inpatient services represented the largest component of healthcare costs at $29,896 per patient annually, followed by pharmacy ($9,453) and outpatient ($6,196) costs, demonstrating the large burden on commercial and public healthcare programs. Antidepressants were the most frequently used medication class (48.2%), followed by NSAID analgesics (43.4%), anticonvulsants (41.6%), gastric acid secretion reducers (41.5%), skeletal muscle relaxants (40.7%), and opioid analgesics (39.4%). The medication use reflects reliance on multimodal pharmacologic strategies to manage fibromyalgia-related symptoms in routine clinical practice.

A copy of the Company’s poster presentation, “Characterizing Patients with Fibromyalgia: A U.S. Real-World Claims Analysis,” is available under the Scientific Presentations tab on the Tonix website at https://www.tonixpharma.com/scientific-presentations/.

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 more than 10 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, 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. Physicians and patients report common dissatisfaction with currently marketed products.

About TONMYA® (cyclobenzaprine HCl sublingual tablets)

TONMYA (cyclobenzaprine HCl sublingual tablets) 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 multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TONMYA was approved on August 15, 2025, by the FDA for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. TNX-102 SL is also being developed to treat acute stress disorder (ASD)/acute stress reaction (ASR), and major depressive disorder (MDD). 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. 10,357,465 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 TONMYA composition. These patents are expected to provide TONMYA with U.S. market exclusivity until 2034/2035.

Citations

1. Bilge U, et al. Cardiovasc Dis. 2018;155:30–5.
2. Choy EH, Mease PJ. Rheum Dis Clin North Am. 2009;35(2):329–37.
3. Rivera FA, et al. Front Med (Lausanne). 2023;10:1301944.
4. Winslow BT, et al. Am Fam Physician. 2023;107(2):137–44.

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) disorders, infectious diseases, immunology conditions, and rare diseases where there exists high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s flagship internally conceived and developed medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is extending the science behind TONMYA in Phase 2 clinical studies to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including monoclonal antibody TNX-4800 (anti-OspA mAb) for Lyme disease prevention in the U.S. and TNX-801 (horsepox, live virus vaccine), a vaccine in development for the prevention of mpox and smallpox. Within immunology, Tonix is developing TNX-1500 (anti-CD40L mAb), a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. Finally, the Company’s rare disease portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome. To learn more, visit www.tonixpharma.com.

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

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

Forward Looking Statements

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

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

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

Media Contacts
Deborah Elson
Tonix Pharmaceuticals
[email protected]

Ray Jordan
Putnam Insights
[email protected]

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.

Released May 26, 2026

Eledon Pharmaceuticals (ELDN) – Tegoprubart Data Update Scheduled For June 2026

Posted on by [email protected]


Friday, May 22, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Data Updates To Be Presented In June 2026. Eledon has announced that additional data will be presented at the American Transplant Congress on June 22, 2026. The presentations will include long-term data from patients in the Phase 2 BESTOW trial and its extension study. We expect to see longer follow-up periods from additional patients than previously seen, showing outcomes, side-effect profiles, and organ survival in comparison with the standard of care, tacrolimus.

Conference Call Has Been Scheduled To Discuss Data. Eledon will hold a conference call at 8 AM on June 22 to discuss the data. This will be after the Saturday, June 20, poster presentation titled,” Phase 2 BESTOW Extension Trial Evaluating Tegoprubart’s Long-Term Safety and Efficacy in Preventing Kidney Transplant Rejection”, and before the Monday, June 22, oral presentation titled “Phase 2 BESTOW Trial: Evaluating Tegoprubart’s Safety and Efficacy in Preventing Kidney Transplant Rejection” at 12 PM.


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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. 

Cardiff Oncology (CRDF) – 1Q26 Announced With Onvansertib Progress Toward Phase 3

Posted on by [email protected]


Friday, May 22, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Cardiff To Present Data At ASCO. Cardiff Oncology reported a 1Q26 loss of  $12.4 million or $(0.18) per share. Important developments during the quarter include scheduling presentation of the Phase 2b trial, discussed in our Research Note on January 28, at the ASCO Annual Meeting from May 29 to June 2. A meeting with the FDA was held in April, with the Phase 3 trial still expected to begin in late FY2026. Cash on March 31, 2026, was $46.1 million.

End-of-Phase-2 Meeting With The FDA Completed. During 1Q26, the company held an End-of-Phase-2 Meeting with the FDA to obtain guidance on the Phase 3 design and regulatory approval requirements. As expected, the trial will enroll patients with RAS-mutated metastatic colorectal cancer (mCRC), treated with a combination of FOLFIRI with bevacizumab (Avastin) and the 30 mg dose of onvansertib. This is the regimen that produced the strongest results in the Phase 2b trial.


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

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

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

GeoVax Labs (GOVX) – Recent Events Put GeoVax Programs For Mpox, Ebola, and Infectious Disease Programs In The Spotlight

Posted on by [email protected]


Tuesday, May 19, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

WHO Has Declared Ebola A Public Health Emergency. On Sunday, May 17, the World Health Organization (WHO) declared Ebola a Public Health Emergency of International Concern (PHEIC), the highest level of global health alert it can issue. We believe the World Health Assembly in Geneva, Switzerland, held from May 18 to May 23, is increasing attention to outbreaks of Mpox, Ebola, and other infectious diseases. GeoVax is one of the few companies that has developed vaccines against these diseases.

GeoVax Has Overlooked Programs For Additional Infectious Diseases. GeoVax has completed pre-clinical work testing vaccines for hemorrhagic fever viruses, including Ebola, Sudan, and Marburg. It has developed these vaccines in collaborations with the National Institutes of Health, but has focused its resources on GEO-MVA, CM-04S1, and Gedeptin. The increased attention to Ebola could help obtain non-dilutive funding for these programs.


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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. 

Eledon Pharmaceuticals (ELDN) – Eledon Confirms Clinical Milestones With 1Q26 Report

Posted on by [email protected]


Monday, May 18, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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1Q26 Report Included Milestones For FY2026. Eledon reported a Loss From Operations of $21.2 million, before interest income and a non-cash charge of $19.0 million from Changes in the Fair Value of Warrant Liabilities. This brought the 1Q26 Net Loss to $39.0 million or $(0.33) per share. The quarterly report confirmed our expectations for progress toward a Phase 3 trial in renal transplantation, as well as additional clinical trials in other organ transplants. Cash on March 31, 2026, was $111.1 million.

Several Clinical Milestones Are Expected For Renal Transplantation. We expect continued discussions with the FDA on the Phase 3 trial design and approval requirements. As discussed in our Research Note on February 2, additional long-term data from the Phase 1b trial were presented, with additional presentations of Phases 1b and 2 BESTOW extension data planned. We expect these studies to further support its safety profile and kidney function benefits.


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Unicycive Therapeutics (UNCY) – 1Q26 Reported With OLC On Schedule For June 2026 Approval

Posted on by [email protected]


Wednesday, May 13, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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First Quarter Operating Loss Was Lower Than Our Estimates. Unicycive reported a 1Q Loss From Operations of $8.0 million, compared with our estimate of $9.9 million. An increase of $8.3 million in the Fair Value of Warrant Liabilities resulted in a Net Comprehensive Loss attributable to common shareholders of $12.8 million, or $(0.54) per share. Importantly, the company confirmed that NDA approval for OLC is on track to meet the June 29 PDUFA date. Cash on March 31, 2026, was $57.1 million.

We Expect OLC Approval By The PDUFA Date. The NDA for OLC (oxylanthanum calcium) was submitted in December and accepted for review in January. We believe the preclinical and clinical sections have already passed FDA review, and previous manufacturing problems associated with a contract manufacturer have been corrected. We expect OLC to receive FDA approval on or before its June 29, 2026, approval date.


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Release – Gyre Therapeutics Announces NMPA Acceptance of New Drug Application for F351 (hydronidone) for CHB-Induced Liver Fibrosis Treatment

Posted on by [email protected]

May 12, 2026

PDF Version

SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) — Gyre Therapeutics, Inc. (“Gyre”, “Gyre Therapeutics” or the “Company”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company with operations in the United States and China, today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for F351 (hydronidone) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus (HBV). The acceptance comes after the NMPA previously granted priority review status for F351 in March after Gyre submitted the NDA through its majority-owned subsidiary Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals). This marks the second major product for which Gyre has submitted an NDA to the NMPA, and is a significant milestone for the Company in the commercialization of a new medication for the treatment of CHB-induced liver fibrosis.

Dr. Ying Luo, President and Chief Executive Officer of Gyre, commented, “This is another significant achievement for Gyre. This NDA is our third submission accepted for review by the NMPA, and the first one for our F351 program. Our interactions with the CDE have been very positive to date, reinforcing the agency’s support for addressing the medical need to treat liver fibrosis and the potential of F351 as an innovative therapeutic option. If approved, F351 could address the tens of millions of patients in China with HBV infection, many of whom will develop liver fibrosis and potentially cirrhosis. We look forward to working closely with CDE to progress F351 towards commercial approval.”

About Priority Review Designation by the NMPA in China

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

About F351 (hydronidone)

F351 is Gyre’s lead development candidate for the treatment of liver fibrosis that is being developed for two different indications. It is a structurally modified derivative of pirfenidone designed to optimize metabolic properties while targeting the TGF-β1 signaling pathway, a key mediator of fibrogenesis. Gyre is developing F351 for two primary indications: Chronic hepatitis B (CHB)-associated liver fibrosis in the People’s Republic of China (PRC) and MASH-associated liver fibrosis initially in the United States.

In the United States, Gyre has completed a Phase 1 clinical trial in healthy volunteers evaluating F351’s safety, tolerability, and PK. Gyre plans to file an Investigational New Drug (IND) application in the U.S. by the end of 2026, and, if the IND becomes effective, to initiate a Phase 2 clinical trial.

About CHB-Induced Liver Fibrosis

Liver fibrosis is a condition where healthy tissues in the liver become scarred in response to chronic inflammation. If left untreated, it can progress to cirrhosis—the final, severe stage where extensive scarring permanently distorts the liver’s architecture and significantly impairs its vital functions. Viral hepatitis is estimated to cause up to 50% of fibrosis and 65% of cirrhosis worldwide. Without intervention, liver fibrosis and cirrhosis typically progress from manageable organ damage to systemic, life-threatening liver failure and hepatocellular carcinoma (HCC). No non-viral directed therapy has been shown to reduce fibrosis in viral induced hepatitis.

About Gyre Pharmaceuticals

Gyre Pharmaceuticals Co., Ltd., a subsidiary of Gyre Therapeutics, Inc., is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY™ (pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share over the past several years. In addition, Gyre Pharmaceuticals’ pipeline includes F351 (hydronidone), a structural analogue of pirfenidone, which demonstrated statistically significant fibrosis regression after 52 weeks of treatment in a pivotal Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC. F351 received Breakthrough Therapy designation by the CDE of the NMPA in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, RILI with or without immune-related pneumonitis, COPD, PAH and ALF/ACLF. As of March 31, 2026, Gyre Therapeutics owns a 69.7% equity interest in Gyre Pharmaceuticals.

About Gyre Therapeutics

Gyre Therapeutics is a commercial-stage biopharmaceutical company headquartered in San Diego, CA focused on the development and commercialization of small-molecule therapeutics with its most advanced programs addressing organ fibrosis and inflammatory diseases.

Gyre’s wholly-owned subsidiary, Cullgen Inc., is a clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader and degrader-antibody conjugate (DAC) therapies for critical conditions including cancer and inflammatory diseases. Cullgen has created a portfolio of highly selective targeted protein degrader and DAC product candidates designed to potently and efficiently eliminate therapeutically relevant proteins in patients.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the development and commercial potential and potential benefits of F351; the timing and progression of commercial approval of F351; and the timing of Gyre’s IND application in the U.S., and, if the IND becomes effective, initiation of a Phase 2 clinical trial for F351. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: unexpected costs, charges or expenses resulting from the acquisition; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the acquisition; the risk that the combined company may not be able to successfully integrate the businesses and realize the expected benefits of the acquisition in a timely manner or at all; the uncertainties associated with Gyre’s and Cullgen’s product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; risks related to the inability of the combined entity to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks associated with the possible failure to realize certain anticipated benefits of the acquisition, including with respect to future financial and operating results. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2025 filed on March 13, 2026, and in other filings with the Securities and Exchange Commission.

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

CONTACTS:

Gyre Therapeutics, Inc.

Thomas Eastling, CFO
[email protected]

Investors

Chuck Padala
Managing Director, LifeSci Advisors
[email protected]

The Oncology Institute, Inc. (TOI) – 1Q26 Results Show Strong Revenue Growth With Increasing Financial Leverage

Posted on by [email protected]


Friday, May 08, 2026

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

1Q26 Reported Strong Growth In Revenues. The Oncology Institute reported a net loss of $2.5 million or $(0.02) per share. Total Revenues of $147.4 million met our expectations with 41% growth over 1Q25. On the quarterly conference call, the company raised Free Cash Flow guidance to a range of $5 million to $15 million from the previous range of $(15) million to $5 million. Cash on March 31, 2026, was $30.3 million.

Financial Measures Showed Strong Growth Over 1Q25. TOI continues to show strong increases in the number of covered lives, leading to both year-over-year and sequential quarterly increases in revenues. Increased volume in Dispensary Services resulted in revenue of $87.5 million, representing 78% growth over 1Q25, while Patient Services revenues of $59.1 million showed 11% growth over 1Q25.


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Healthcare Staffing Leader Cross Country Healthcare Agrees to $437M Buyout — And Walks Away From Nasdaq

Posted on by [email protected]

Cross Country Healthcare (Nasdaq: CCRN), a Boca Raton-based healthcare workforce solutions company, announced Tuesday it has entered into a definitive agreement to be taken private by San Francisco-based investment firm Knox Lane in an all-cash transaction valued at approximately $437 million. The deal represents one of the more notable small-cap M&A events in the healthcare sector so far in 2026, and it signals continued private equity appetite for AI-enabled workforce technology platforms.

Knox Lane will acquire all outstanding shares of CCRN at $13.25 per share — a 31% premium to the stock’s closing price on May 6 and a 45% premium to its 90-day volume-weighted average price. For shareholders who have been watching the stock lag in a difficult staffing market, the premium offers a meaningful exit at a price the public markets had not recently rewarded.

Once the deal closes — expected in Q3 2026, pending stockholder approval and regulatory sign-off — Cross Country Healthcare will delist from Nasdaq and operate as a privately held platform company within Knox Lane’s portfolio. The company will retain its name and brand.

At the core of this acquisition is Cross Country’s proprietary technology stack, particularly its Intellify® platform — a cloud-based workforce and vendor management system that integrates with hospital infrastructure to give health system leaders real-time visibility across both internal and contingent labor. The platform spans nursing, allied health, non-clinical, and locum tenens staffing and uses AI-driven analytics to help organizations forecast demand, reduce labor costs, and optimize workforce utilization. For a private equity firm, that kind of deeply embedded, data-rich platform is exactly the type of asset that becomes considerably more valuable away from the quarterly earnings pressure of the public markets.

Knox Lane’s investment thesis here is straightforward: take a company with four decades of operational credibility and a defensible technology moat, remove the public market constraints, and accelerate growth with additional strategic capital and operator support. The firm has built a reputation around exactly this playbook — pairing financial resources with sector expertise in areas like human capital, AI transformation, and supply chain optimization.

For the broader healthcare staffing market, this transaction is a signal worth watching. The industry has faced persistent headwinds since the post-pandemic surge in travel nurse demand normalized, compressing margins across the sector. CCRN’s stock had reflected that pressure. But the fact that a growth-oriented PE firm is willing to pay a 45% premium to the 90-day average suggests there is conviction that the demand cycle is closer to a floor than a peak — and that the right platform, properly capitalized and focused, can emerge from this environment in a significantly stronger position.

BofA Securities advised Cross Country Healthcare on the deal, with Davis Polk & Wardwell as legal counsel. Knox Lane was advised by MTS Health Partners, with Kirkland & Ellis serving as legal counsel.

The transaction is expected to close in the third quarter of 2026.

Italian Pharma Giant Angelini Pays $4.1 Billion for Coral Gables-Based Catalyst Pharmaceuticals — and Gets a U.S. Beachhead in the Process

Posted on by [email protected]

Catalyst Pharmaceuticals (Nasdaq: CPRX), the Coral Gables-based rare disease biopharmaceutical company, is being acquired by Rome-headquartered Angelini Pharma in an all-cash deal valued at approximately $4.1 billion — or $31.50 per share. The transaction, unanimously approved by both boards, marks one of the largest biopharma acquisitions of a U.S.-listed rare disease company so far in 2026, and it carries particular significance for Angelini: it’s the Italian pharma group’s formal entry into the U.S. market after more than a century of operations centered in Europe.

The deal price represents a 21% premium to Catalyst’s unaffected closing share price on April 22 — the last trading day before deal speculation began leaking into the market — and a 28% premium to the 30-day volume-weighted average price through that same date. Blackstone funds are participating in the transaction alongside select international partners, with BNP Paribas acting as sole global coordinator and underwriter of the financing package. The acquisition is not subject to a financing condition, and closing is expected in the third quarter of 2026.

For Angelini, the strategic logic is hard to argue with. Catalyst has spent over two decades quietly building one of the more defensible portfolios in rare neurology. Its flagship product, FIRDAPSE® (amifampridine), remains the only FDA-approved, evidence-based treatment for Lambert-Eaton myasthenic syndrome — a rare and debilitating autoimmune disorder — in patients aged six and up. Its second major asset, AGAMREE® (vamorolone), received FDA approval in 2023 as a novel corticosteroid for Duchenne Muscular Dystrophy in patients as young as two. Rounding out the portfolio is FYCOMPA® (perampanel), an antiepileptic drug for partial-onset and generalized tonic-clonic seizures, the U.S. rights to which Catalyst acquired from Eisai in 2023.

That portfolio — three FDA-approved products, all in neurological rare disease, all with established commercial infrastructure — is precisely what Angelini has been building toward. The company has spent the last five years pivoting its global strategy around central nervous system disorders and brain health, including a partnership with Blackstone Life Sciences in GRIN Therapeutics. Acquiring Catalyst doesn’t just add products; it adds a fully operational U.S. commercial engine that would take years and considerable capital to replicate organically.

There’s one additional wrinkle worth noting. Separately from the acquisition announcement, Catalyst disclosed it has resolved pending patent litigation with Hetero USA over a generic FIRDAPSE challenge. The settlement — terms of which are confidential and subject to FTC and DOJ review as required by law — eliminates a key IP overhang that had lingered over the company’s most critical revenue-generating asset. The timing of that resolution, announced alongside a $4.1 billion buyout, is not coincidental. Clean IP, commercial scale, and a motivated foreign buyer: Catalyst’s management team played this about as well as a rare disease company could.

For CPRX shareholders, the deal delivers immediate, certain cash value at a meaningful premium after the stock had already performed well relative to the broader small-cap biotech landscape. Once the deal closes, Catalyst will operate as a wholly owned subsidiary of Angelini Pharma and delist from Nasdaq.

J.P. Morgan advised Catalyst. Centerview Partners, BNP Paribas, and Morgan Stanley co-advised Angelini Pharma.