Category: Healthcare

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.

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

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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*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) – 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.

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

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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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 – 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.

Release – Tonix Pharmaceuticals Secures Commercial Payer Coverage for TONMYA®, Providing Access for ~35 Million U.S. Patients

Posted on by [email protected]
Primary Logo

May 06, 2026 7:00am EDT

Agreement with leading group purchasing organization (GPO) provides access to approximately 35 million U.S. commercial lives (20% of ~177 million commercial lives in the U.S.)

TONMYA (cyclobenzaprine HCl sublingual tablets), the first FDA-approved treatment for fibromyalgia in adults in more than 15 years, commercially launched in November 2025

TONMYA is a first-in-class non-opioid analgesic indicated for the treatment of fibromyalgia in adults as a daily bedtime medicine for long-term use

BERKELEY HEIGHTS, N.J., May 06, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully integrated, commercial biotechnology company, today announced an agreement effective May 1, 2026, with a leading group purchasing organization (GPO) that provides coverage to approximately 35 million U.S. commercial lives, representing approximately 20% of the roughly 177 million commercial lives in the U.S., with standard utilization management criteria, for TONMYA® (cyclobenzaprine HCl sublingual tablets).

“This agreement is an important milestone in expanding patient access to TONMYA,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “We are encouraged by this first partnership with managed care and look forward to continuing to pursue additional coverage across commercial and government channels.”

Dr. Lederman continued, “TONMYA is a first-in-class non-opioid analgesic indicated for the treatment of fibromyalgia in adults. TONMYA is the first new FDA-approved treatment option for fibromyalgia in over 15 years. Fibromyalgia patients have experienced dissatisfaction with available therapies, with 85% of first-line treatments failing due to efficacy and tolerability issues.1,2 We are committed to providing patient access to TONMYA by continuing to engage with commercial payers on its value and offering a patient support program to help patients access their prescribed medication.”

Tonix also continues to progress discussions with Medicare and Medicaid. To date, TONMYA is covered under Medicaid in 38 states for approximately 55 million lives representing 73% of the roughly 75 million Medicaid lives.

The TONMYA Together Support Program offers a savings program to eligible, commercially insured patients through local pharmacies and through a digital pharmacy service. Terms and conditions apply, subject to change. Learn more at https://www.tonmya.com/savings.

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
1Robinson RL, et al. Pain Med. 2012 13(10):1366-76. doi: 10.1111; 85% received drug treatment.
2EVERSANA primary physician research, May 2024; commissioned by Tonix.

Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg) is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD154/CD40 ligand (CD40L) inhibitor for the prevention of kidney transplant rejection. In addition, Tonix is progressing TNX-2900 (intranasal potentiated oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. 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.

Source: Tonix Pharmaceuticals Holding Corp.

Released May 6, 2026

Ocugen (OCGN) – 1Q26 Reported With Senior Convertible Note Offering

Posted on by [email protected]


Wednesday, May 06, 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.

Clinical Progress During 1Q26 Reviewed. Ocugen reported 1Q26 loss of $19.1 million or $(0.06) per share, slightly higher than we estimated. On its quarterly conference call, management reiterated several important clinical milestones in the coming year. The company also completed an offering of $115 million in Convertible Senior Notes, which we estimate is enough cash to bring its three lead products to market and fund operations through early 2028. The proposal to allow for a reverse split has been dropped from the Annual Meeting agenda.

Senior Note Offering Provides Sufficient Cash For Product Introductions. The cash balance on March 31, 2026, was $32.2 million, including proceeds of $37.5 million from warrant exercise in 1Q26. Today, the company completed the sale of $115 million in 6.75% Convertible Senior Notes. including an option for the buyer to purchase an additional $15 million in the next 13 days. These Notes should add about $99.5 million to the cash balance. Based on our estimates, we believe this is sufficient to fund operations through the filing of the BLAs and product introductions expected in 2026-2028.


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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. 

SelectQuote (SLQT) – Strong Q3 Execution Highlights Profitability and Cash Flow Strength

Posted on by [email protected]


Wednesday, May 06, 2026

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

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

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

Strong Q3 Adj EBITDA. The company reported fiscal Q3 revenue of $430.9 million and adj. EBITDA of $44.6M. While revenue was modestly lower than our estimate of $449.0M, adj. EBITDA strongly outperformed our estimate of $35.0M. Notably, adj. EBITDA benefited from a favorable $14.0M adjustment to commissions receivables and continued operational discipline.

Underlying profitability remains solid. Normalized EBITDA margins were approximately 7% after excluding the one-time commission benefit. Core operating performance appears to be improving. The Senior segment demonstrated resilience despite ongoing headwinds in Medicare Advantage. Healthcare Services (SelectRx) revenue grew 5% YoY to $199M, driven by continued membership growth and higher prescription utilization per member.


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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 – Gyre Therapeutics Completes Acquisition of Cullgen to Create U.S.- and China-based Fully Integrated Biopharmaceutical Company

Posted on by [email protected]

May 4, 2026

  • Post-closing combined company has revenue-producing commercial asset and a robust pipeline of products and product candidates to address multiple therapeutic areas with a focus on fibrosis and inflammatory diseases.
  • China innovation engine provides cost-efficient vehicle for discovery and early-stage development of targeted protein degraders and degrader-antibody conjugates.
  • Strengthened leadership team in U.S., coupled with China operating presence to support future global growth.

SAN DIEGO, May 04, 2026 (GLOBE NEWSWIRE) — Gyre Therapeutics, Inc. (“Gyre”, “Gyre Therapeutics” or the “Company”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic diseases, today announced the closing of its acquisition of Cullgen Inc. (Cullgen), a privately-held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader (TPD) and degrader antibody conjugate (DAC) therapies, in an all-stock transaction valued at approximately $300 million.

Following the closing of the acquisition, Cullgen became a wholly owned subsidiary of Gyre, and the former Chief Executive Officer of Cullgen, Dr. Ying Luo, was appointed President and Chief Executive Officer and as a member of the Gyre Board of Directors. Ping Zhang will continue at Gyre as Chairman of the Board of Directors. The new combined entity will continue to be listed on the Nasdaq Capital Market under the ticker “GYRE”.

Dr. Luo, President and Chief Executive Officer of Gyre, commented, “We are eager to move forward as a U.S.- and China-based fully integrated biopharmaceutical company. Through this combination, we have created an entity that not only offers a commercial-stage product with ETUARY®, on the market in China for the treatment of lung fibrosis, but also a full-spectrum pipeline of products from discovery to Phase 3, primarily focused on fibrosis and inflammatory diseases. This includes our lead product candidate, F351 (hydronidone) for the treatment of chronic hepatitis B (CHB)-induced liver fibrosis, as well as a strong preclinical and clinical pipeline, including TPDs and DACs.”

Mr. Zhang, Chairman of Gyre, commented, “This combination occurs at an exciting time for Gyre as we recently received priority review status from the Center for Drug Evaluation of China’s National Medical Products Administration for the F351 NDA in March. We are also exploring the expansion of F351’s development in ex-China territories including the U.S. In addition, we have completed enrollment in our 52-week Phase 3 ETUARY® trial for pneumoconiosis, and have also enrolled the first patient in a Phase 3 study evaluating ETUARY® in a new indication: radiation-induced lung injury with or without immune checkpoint inhibitor-related pneumonitis, further strengthening our late-stage inflammatory portfolio. Additionally, we believe the innovative discovery engine that has produced several promising degraders and DACs acquired from Cullgen strengthens our asset portfolio and provides long-term value to Gyre.”

About Gyre Pharmaceuticals

Gyre Pharmaceuticals Co., Ltd., a subsidiary of Gyre Therapeutics, Inc. (“Gyre Pharmaceuticals”), is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (pirfenidone capsule), was the first approved treatment for IPF in the People’s Republic of China (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 December 31, 2025, Gyre Therapeutics owns a 69.7% equity interest in Gyre Pharmaceuticals.

About Gyre Therapeutics

Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of F351 for liver fibrosis including MASH in the U.S., and, with its recent acquisition, now has a portfolio of highly selective targeted protein degrader product candidates designed to potently and efficiently eliminate therapeutically relevant proteins in patients, as well as preclinical programs including next-generation degrader-antibody conjugates.

In the PRC, Gyre Therapeutics is advancing a broad pipeline through its controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, and F528.

Advisory and Legal Counsel

Moelis & Company LLC is acting as financial advisor to the special committee to Gyre’s Board of Directors, and Gyre’s legal counsel is Gibson, Dunn & Crutcher LLP.

Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. is serving as legal counsel to Cullgen.

ARCHIMED to Take Esperion Therapeutics Private in Deal Valued at Up to $1.1 Billion

Posted on by [email protected]

Esperion Therapeutics (Nasdaq: ESPR), the Ann Arbor-based commercial-stage biopharmaceutical company behind a growing portfolio of cardiometabolic therapies, is set to leave public markets after striking a definitive acquisition agreement with ARCHIMED, a Europe-headquartered healthcare-focused private equity firm with €9 billion in assets under management.

Under the terms of the deal announced May 1, 2026, Esperion shareholders will receive $3.16 per share in cash at closing — a 58% premium to the company’s closing share price on April 30 — along with one non-tradeable contingent value right (CVR) that entitles holders to participate in up to $100 million in additional milestone payments tied to future commercial performance. The total equity value of the transaction reaches approximately $1.1 billion on a fully diluted basis, assuming full achievement of those milestones.

The CVR Structure: Upside With Conditions

The contingent payment component is split into two tranches. The first is tied to annual U.S. net sales of bempedoic acid-containing products — primarily NEXLETOL and NEXLIZET — in calendar year 2027. Shareholders can receive up to $40 million in aggregate if those products surpass $350 million in annual sales, with a pro-rated payout if sales fall between $300 million and $350 million.

The second tranche is tied to ENBUMYST, Esperion’s bumetanide-based therapy, and pays out $60 million in aggregate if annual U.S. net sales hit or exceed $160 million in any single calendar year through December 31, 2030.

This CVR structure places meaningful commercial risk on post-close performance, particularly for ENBUMYST, which is the earlier-stage product of the two. Investors accepting the deal should weigh the probability of those sales thresholds being met before banking on the full $1.1 billion figure.

Why This Deal Makes Strategic Sense

Cardiovascular disease remains the leading cause of death globally, and the market for non-statin LDL-C lowering therapies has been steadily expanding. Esperion’s NEXLETOL and NEXLIZET have established commercial infrastructure in the U.S. and regulatory approvals in more than 40 countries, giving ARCHIMED a platform with real geographic reach and an active pipeline.

ARCHIMED’s exclusive focus on healthcare industries and its international network across Europe, North America, and Asia positions it to potentially accelerate Esperion’s international commercial strategy — something that can be difficult to execute efficiently inside a small-cap public company under the constraints of quarterly earnings pressure.

Deal Mechanics and Timeline

Debt financing for the acquisition is being provided by Pharmakon Advisors, LP, a specialized life sciences lender that has deployed up to $11 billion across 73 investments. The transaction carries no financing condition, which reduces deal risk meaningfully.

Esperion’s Board of Directors unanimously approved the deal and is recommending shareholder approval. The transaction is expected to close in the third quarter of 2026, pending shareholder vote and regulatory clearance. Moelis & Company is advising ARCHIMED, while Centerview Partners is advising Esperion.

Once the deal closes, Esperion will be delisted from Nasdaq and operate as a privately held company — removing a once-public cardiometabolic pure-play from the small-cap biotech universe.

Cadrenal Therapeutics (CVKD) – Preliminary Design For CAD-1005 Phase 3 In HIT Announced

Posted on by [email protected]


Friday, May 01, 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.

Phase 3 Design Announced. Cadrenal held an end-of-Phase-2 meeting with the FDA to discuss the results of the CAD-1005 trial and receive guidance for the design of Phase 3. Following the receipt of the Meeting Minutes, the preliminary design for Phase 3 in HIT (Heparin-Induced Thrombocytopenia) has been announced. The trial is expected to begin in late FY2026 to early FY2027, with an NDA possible in FY2019.

HIT Is A Serious Condition. HIT is a potentially life-threatening immune reaction to heparin, an anticoagulant currently used in an estimated 12 million cardiac surgeries. HIT affects up to 5% of these patients, forming immune complexes that can activate platelets and cause excessive clotting. About 50% experience thrombosis, as well as embolisms, skin necrosis, and other cardiac events that can be fatal. CAD-1005 is a selective inhibitor of the 12-LOX immune pathway that causes HIT. This contrasts with other drugs that control symptoms and secondary morbidities following the immune response.


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

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*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 – Ocugen to Host Conference Call on Tuesday, May 5 at 8:30 A.M. ET to Discuss Business Updates and First Quarter 2026 Financial Results

Posted on by [email protected]

Research News and Market Data on OCGN

April 29, 2026

PDF Version

MALVERN, Pa., April 29, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that it will host a conference call and live webcast to discuss the Company’s first quarter 2026 financial results and provide a business update at 8:30 a.m. ET on Tuesday, May 5, 2026.

Ocugen will issue a pre-market earnings announcement on the same day. Attendees are invited to participate on the call using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 4973685
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available on the Ocugen investor site.

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

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

Contact:
Tiffany Hamilton
AVP, Head of Communications
[email protected]