Category: Health

Release – Cadrenal Therapeutics Reports First Quarter 2026 Financial Results and Provides Phase 3 Development Update on CAD-1005 Following End-of-Phase 2 Meeting with FDA

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Research News and Market Data on CVKD

Official FDA meeting minutes and Phase 2 data provide guidance on the pivotal Phase 3 registration path for CAD-1005 in heparin-induced thrombocytopenia (HIT)

PONTE VEDRA, Fla., May 07, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today reported its financial results for the first quarter ended March 31, 2026, and provided a corporate update highlighting continued progress in its CAD-1005 program for HIT. The Company has now received the official minutes from its End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), which provided guidance on key elements of the planned pivotal Phase 3 registration trial for CAD-1005, Cadrenal’s investigational first-in-class 12-lipoxygenase (12-LOX) inhibitor being developed to treat suspected heparin-induced thrombocytopenia (HIT). Based on this feedback and Phase 2 data, Cadrenal plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to standard-of-care anticoagulation in patients with HIT.

Recent Highlights

  • Received official FDA EOP2 meeting minutes providing guidance on protocol design, study population, dosing, background therapy, exposure, safety database, and the primary endpoint of new or worsening thrombotic events.
  • After considering FDA feedback on a pivotal registration study, Cadrenal plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to the current standard of care for patients with HIT.
  • Planned pivotal Phase 3 study, the first randomized, blinded, placebo-controlled registration trial in HIT, will evaluate CAD-1005 in approximately 120 patients across clinical centers worldwide and is intended to support a projected NDA submission in 2029.
  • Primary endpoint, centrally adjudicated, is expected to be the incidence of new or worsening thrombotic events in patients with Serotonin Release Assay (SRA)-confirmed HIT, with at least one planned interim analysis.
  • Phase 2 data showed an absolute reduction of more than 25% in thrombotic events when CAD-1005 was added to standard anticoagulant therapy, supporting the continued advancement of CAD-1005 as Cadrenal’s near-term development priority.
  • Continues to position CAD-1005 as a first-in-class, selective 12-LOX inhibitor and the only treatment in clinical development that targets the underlying immune drivers of HIT, supported by Orphan Drug and Fast Track designations from the FDA and by orphan drug status from the European Medicines Agency.

“With the official EOP2 meeting minutes now in hand, we believe the registration path for CAD-1005 in HIT is clearly defined,” commented Quang X. Pham, Chairman & CEO. “The FDA’s guidance on trial design and the primary endpoint of new or worsening thrombotic events reinforces our confidence in advancing directly to a pivotal Phase 3 study. We believe CAD-1005 has the potential to be the first new therapy for HIT in more than two decades.”

First Quarter 2026 Financial Highlights

Research and development expenses for the quarter ended March 31, 2026, were $0.8 million compared to $1.7 million for the same period in 2025. General and administrative expenses were $1.7 million compared to $2.3 million for the same period in 2025. Total operating expenses were $2.5 million compared to $3.9 million for the same period in 2025. Cadrenal reported a net loss of $2.5 million for the quarter ended March 31, 2026, compared to $3.8 million for the same period in 2025.

As of March 31, 2026, Cadrenal had cash and cash equivalents of $2.3 million. Subsequent to quarter end, on April 1, 2026, the Company completed a $2.5 million financing, providing additional capital to support near-term development activities. The Company continues to evaluate financing and strategic alternatives to support its planned clinical development activities, including the anticipated pivotal Phase 3 trial of CAD-1005 in HIT.

The Company is advancing Phase 3 readiness activities, including protocol finalization, and expects to provide further updates in the coming quarters.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is a first-in-class 12-LOX inhibitor being developed to treat heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration and orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also in development for chronic indications.

The Company’s broader pipeline includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and those with left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor intended for use in acute hospital settings.

For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include, without limitation, statements regarding continued progress in its CAD-1005 program for HIT ; plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to standard-of-care anticoagulation in patients with HIT; the planned pivotal Phase 3 study being the first randomized, blinded, placebo-controlled registration trial in HIT; the Phase 3 study evaluating CAD-1005 in approximately 120 patients across clinical centers worldwide; the trial supporting a projected NDA submission in 2029; the incidence of new or worsening thrombotic events in patients with Serotonin Release Assay (SRA)-confirmed HIT being the primary endpoint of the trial; the trial having at least one planned interim analysis; continuing to position CAD-1005 as a first-in-class, selective 12-LOX inhibitor and the only treatment in clinical development that targets the underlying immune drivers of HIT; the registration path for CAD-1005 in HIT being clearly defined; and CAD-1005 having the potential to be the first new therapy for HIT in more than two decades. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to raise sufficient capital to continue progress of CAD-1005; the ability to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to standard-of-care anticoagulation in patients with HIT; the ability to successfully design and complete the Phase 3 study and derive the results needed for an NDA submission: and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
[email protected]

View full release here.

Release – Gyre Therapeutics Reports First Quarter 2026 Results and Provides Business Update

Posted on by [email protected]

Research News and Market Data on GYRE

May 7, 2026

PDF Version

Q1 2026 revenue of $22.5 million; GAAP basic EPS: $(0.10)

Full year 2026 revenue guidance of $100.5 to $111.0 million affirmed

NDA for F351 (hydronidone) for CHB-associated liver fibrosis submitted to China’s CDE in March 2026

Completed acquisition of Cullgen in an approximately $300 million all-stock transaction, expanding pipeline into inflammatory diseases and cancers

First patient enrolled in Phase 2/3 trial evaluating ETUARY™ for radiation-induced lung injury, including immune-related pneumonitis

SAN DIEGO, May 07, 2026 (GLOBE NEWSWIRE) — Gyre Therapeutics, Inc. (Gyre, the Company or Gyre Therapeutics) (Nasdaq: GYRE), an innovative, commercial stage biopharmaceutical company with operations in the United States and China, today announced financial results for the first quarter ended March 31, 2026, and provided a business update.

“Building on our successful pre-NDA meeting with China’s CDE at the beginning of the year, we are particularly encouraged by the NMPA’s priority review designation for F351, reinforcing both the strength of our clinical data and the significant unmet need in liver fibrosis,” said Ying Luo, Chief Executive Officer of Gyre Therapeutics. “In parallel, our acquisition of Cullgen expands our capabilities into targeted protein degradation, positioning Gyre to drive long-term innovation beyond fibrosis. We believe these achievements strengthen our foundation as a fully integrated, multi-national biopharmaceutical company as we advance our mission to deliver transformative therapies to patients worldwide.”

First Quarter Business Highlights and Upcoming Milestones

Commercial Products:

ETUARY™ (pirfenidone), the Company’s primary product, generated $21.0 million in sales for the quarter ended March 31, 2026, compared to $21.7 million for the same period in 2025. Etorel™ (nintedanib ethanesulfonate soft capsules), which was launched in June 2025, generated $0.7 million in sales for the quarter ended March 31, 2026. Contiva™ (avatrombopag maleate tablets), launched in March 2025, generated $0.8 million in sales for the quarter ended March 31, 2026, compared to $0.3 million for the same period in 2025.

Pipeline Development Updates

Hydronidone (F351):

In March 2026, Gyre announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) granted priority review designation to F351 for the treatment of chronic hepatitis B (CHB)-associated liver fibrosis. Subsequently, Gyre, through its majority-owned subsidiary Gyre Pharmaceuticals Co., Ltd., submitted a New Drug Application (NDA) to the CDE to seek conditional approval for this indication, which is currently under completeness review for acceptance.

Pirfenidone (ETUARY™):

A Phase 3 trial of pirfenidone for the treatment of pneumoconiosis (PD) in the People’s Republic of China (PRC) completed enrollment in 2025. A total of 272 patients were enrolled evaluating the efficacy and safety of 52 weeks of pirfenidone capsule treatment in patients with PD versus placebo. The final patient is expected to complete the study in the third quarter of 2026.

In April 2026, Gyre initiated its adaptive Phase 2/3 clinical trial in oncology-related pulmonary complications, with the first patient enrolled. The trial is evaluating pirfenidone for radiation-induced lung injury (RILI), including cases complicated by immune-related pneumonitis, at leading oncology centers.

Corporate Updates:

  • In March 2026, Gyre announced its acquisition of Cullgen Inc., a clinical-stage biopharmaceutical company, to create a fully integrated biopharmaceutical company with U.S.- and China-based capabilities. The transaction was completed in May 2026. The acquisition will supplement Gyre’s fibrosis-focused pipeline with novel targeted protein degrader and degrader antibody conjugate product candidates designed to eliminate therapeutically relevant proteins in patients for the treatment of critical conditions including inflammatory diseases and cancers.
  • Concurrent with the acquisition of Cullgen, Gyre is undertaking a comprehensive evaluation of its pipeline and clinical development strategy to prioritize programs across the combined organization. The Company intends to provide further updates regarding its strategic direction upon completion of this evaluation.

Financial Results

Cash Position

As of March 31, 2026, Gyre held $37.5 million in cash and cash equivalents, $12.3 million in short-term bank deposits, and $29.4 million in long-term certificates of deposit, totaling $79.2 million. Compared to $75.9 million as of December 31, 2025, total cash increased by $3.3 million, or 4%, primarily driven by higher customer collections and reduced tax payments.
Financial Results for the Three Months Ended March 31, 2026

  • Revenues: Revenues for the three months ended March 31, 2026 were $22.5 million, compared to $22.1 million for the same period in 2025. The $0.4 million, or 2%, increase was primarily due to the increase in Contiva™ and Etorel™ sales by approximately $0.5 million and $0.7 million, respectively, partially offset by the decrease in ETUARY™ sales and other products sales by approximately $0.7 million and $0.1 million, respectively. Contiva™ was launched in March 2025, and Etorel™ was not commercially launched until June 2025. ETUARY™ revenue declined by approximately 3% year-over-year, primarily attributable to the seasonal fluctuation in 2026 compared to 2025.
  • Cost of Revenues: For the three months ended March 31, 2026, cost of revenues was $1.2 million, compared to $0.9 million for the same period in 2025. The $0.3 million, or 37%, increase was primarily driven by to a $0.3 million rise in early production costs for Etorel™ cost of sales and a $0.2 million increase in stock-based compensation expense, partially offset by a $0.2 million decrease in ETUARY™ cost of sales.
  • Selling and Marketing Expense: For the three months ended March 31, 2026, selling and marketing expense was $14.1 million, compared to $10.8 million for the same period in 2025. The $3.3 million, or 30%, increase was primarily driven by to a $2.9 million increase in promotion expenses for Etorel™ and Contiva™, and early-stage preparation activities for F351 commercial launch, and a $1.0 million increase in stock-based compensation expense, partially offset by a $0.5 million decrease in staff cost due to a decrease in bonus and a $0.1 million decrease in travel and other expenses.
  • Research and Development Expense: For the three months ended March 31, 2026, research and development expense was $6.7 million, compared to $3.1 million for the same period in 2025. The $3.6 million, or 118%, increase was primarily attributable to Gyre Pharmaceuticals and was driven by a $2.0 million increase in clinical research expenses, primarily relating to the Phase 3c and other clinical trial for F351 in the PRC requested by NMPA. The increase also reflects a $0.5 million increase in materials and utilities expenses, and a $1.1 million increase attributable to Gyre Therapeutics’ pre-clinical activities for future investigational new drug (IND) filings in the United States. These costs represent planned investments and are expected to continue in the near- to medium-term.
  • General and Administrative Expense: For the three months ended March 31, 2026, general and administrative expense was $7.3 million, compared to $5.0 million for the same period in 2025. The $2.3 million, or 46%, increase was primarily driven by a $0.8 million increase in stock-based compensation costs, a $0.9 million increase in staff costs due to the Company’s internal realignment of responsibilities and compensation adjustments, and a $0.6 million increase in miscellaneous expenses.
  • Transaction Costs: For the three months ended March 31, 2026, $2.5 million transaction costs were incurred in connection with the acquisition of Cullgen. As the merger transaction closed in early May 2026, we expect there will be additional non-recurring transaction costs incurred after the first quarter of 2026.
  • (Loss) Income from Operations: For the three months ended March 31, 2026, loss from operations was $9.4 million, compared to income from operations of $2.3 million for the same period in 2025. The $11.7 million decrease was primarily driven by $12.1 million increase in total operating expense driven by transactions costs, increased stock based compensation, expanded marketing expenses for Etorel™ and Contiva™, early-stage preparation activities for ETUARY™ and Phase 3c and other clinical trial and pre-clinical activities, partially offset by a $0.4 million increase in revenue.
  • Net (Loss) Income: For the three months ended March 31, 2026, net loss was $9.9 million, compared to net income of $3.7 million for the same period in 2025. The $13.6 million decrease was primarily driven by an increase in operating expenses of $12.1 million, a decrease in other income of $2.2 million, partially offset by a decrease in income tax expense of $0.3 million, and an increase in revenue of $0.4 million.
  • Non-GAAP Adjusted Net (Loss) Income: For the three months ended March 31, 2026, non-GAAP adjusted net loss was $4.2 million, compared to non-GAAP adjusted net income of $2.9 million for the same period in 2025. The $7.1 million decrease was primarily driven by the increase in operating expenses of $5.6 million and a decrease in other income of $2.2 million, offset by an increase in revenue of $0.4 million and a decrease in income tax expenses of $0.3 million.

Use of Non-GAAP Financial Measures by Gyre Therapeutics, Inc.

Gyre reports financial results in accordance with accounting principles generally accepted in the United States (“GAAP”). This release presents the financial measure “adjusted net income,” which is not calculated in accordance with GAAP. The most directly comparable GAAP measure for this non-GAAP financial measure is “net income.” Adjusted net income presents Gyre’s results of operations after excluding gain from change in fair value of warrants, stock-based compensation, and provision for income taxes. This is meant to supplement, and not substitute, Gyre’s financial information presented in accordance with GAAP. Adjusted net income as defined by Gyre may not be comparable to similar non-GAAP measures presented by other companies. Management believes that presenting adjusted net income provides investors with additional useful information in evaluating Gyre’s performance and valuation. See the reconciliation of adjusted net income to net income in the section titled “Reconciliation of GAAP to Non-GAAP Financial Measures” below.

About F351

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 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, initiate a Phase 2 clinical trial.

About Gyre Pharmaceuticals

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™, was the first approved treatment for idiopathic pulmonary fibrosis in the PRC in 2011 and has maintained a prominent market share (2025 net sales of $116.6 million). In addition, Gyre Pharmaceuticals’ pipeline includes F351, 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 NMPA CDE in March 2021. CDE granted priority review status to the NDA for F351 in March 2026. In March 2026, Gyre Pharmaceuticals Co., Ltd., submitted its NDA to the CDE to seek conditional approval for F351. Gyre Pharmaceuticals is also developing treatments for pneumoconiosis, RILI with or without immune-related pneumonitis, chronic obstructive pulmonary disease, pulmonary arterial hypertension and acute/acute-on-chronic liver failure. As of the first quarter of 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 expectations regarding Gyre’s research and development efforts and the timing of expected clinical readouts and regulatory filings, including the timing of the CDE’s review of Gyre Pharmaceuticals’ submission of formal NDA for F351 as a treatment for CHB-induced liver fibrosis and Gyre Pharmaceuticals’ adaptive Phase 2/3 trial of pirfenidone for the treatment of RILI, the future operations of Gyre, the nature, strategy and focus of Gyre, the development and commercial potential and potential benefits of any product candidates of Gyre, the ability of Cullgen’s degraders and DACs to strengthen Gyre’s asset portfolio and the additional expected benefits of the acquisition, including Gyre’s ability to successfully integrate the businesses and operations of Gyre and Cullgen. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital; supply chain and distribution delays and challenges. 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.

Contact:

Ying Luo, Chief Executive Officer and President

[email protected]

View full release here.

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

Release – GeoVax Initiates Phase 3 Execution Activities for GEO-MVA Under EMA-Aligned Immunobridging Pathway

Posted on by [email protected]
GeoVax

Research News and Market Data on GOVX

Company Advances to Active Clinical Execution, Supporting Potential Accelerated Path Toward Regulatory Authorization

ATLANTA, GA – May 6, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies, today announced that it has initiated operational execution activities in support of its planned Phase 3 immunobridging clinical study for GEO-MVA, its Modified Vaccinia Ankara (MVA) vaccine candidate targeting mpox and smallpox.

This milestone marks GeoVax’s transition from strategic program positioning to active clinical-stage execution, following prior regulatory alignment with the European Medicines Agency (EMA) supporting an expedited development pathway.

Execution Activities Now Underway

GeoVax confirmed that multiple core execution workstreams are underway:

  • Clinical Operations: A global contract research organization (CRO) has been selected
  • Trial Infrastructure Activation: Clinical site identification and activation planning progressing in alignment with study requirements
  • Manufacturing Readiness: Clinical trial material manufactured and fill/finish product has been completed and released for clinical use
  • Regulatory Execution Alignment: Ongoing implementation of EMA-guided immunobridging strategy designed to support an efficient path to authorization

The planned Phase 3 immunobridging arm of the clinical trial is expected to enroll approximately 500 participants and evaluate neutralizing antibody responses relative to the approved MVA-based comparator vaccine. This study design intentionally provides rapid clinical validation, further de-risking the program in addition to the expedited development pathway.

From Defined Pathway to Active Execution

“We are now executing against a clearly defined clinical and regulatory pathway for GEO-MVA,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “Our focus has shifted decisively to operational execution of the Phase 3 program. The EMA’s guidance provides a structured and efficient pathway centered on immunobridging, and we are advancing accordingly.”

Dodd added, “Our objective is to move efficiently through study initiation and execution, positioning GEO-MVA to support global preparedness needs while advancing toward potential regulatory authorization.  Our study plan is structured to provide the immunobridging study results within 8-12 weeks following trial initiation.”

Positioned for Efficient Clinical Advancement

The EMA-supported immunobridging approach is designed to:

  • Leverage established MVA platform experience
  • Focus on quantitative neutralizing antibody endpoints
  • Enable a streamlined development pathway relative to traditional efficacy trials

GeoVax believes this approach supports a clear and actionable pathway from development toward potential commercialization.

Addressing a Critical Global Need

GEO-MVA is being advanced as a potential second-source MVA-based vaccine, addressing ongoing global demand for orthopoxvirus vaccines and reducing reliance on a single supplier.

Public health agencies and governments continue to emphasize the importance of resilient and diversified vaccine supply, particularly in the context of evolving mpox dynamics and preparedness requirements.

About GEO-MVA

GEO-MVA is GeoVax’s candidate vaccine for protection against mpox and smallpox based on the Modified Vaccinia Ankara (MVA). The program is advancing under an expedited regulatory pathway supported by EMA scientific advice, which enables potential regulatory approval based on a single immune bridging study demonstrating non-inferiority to an approved MVA vaccine.

Following successful completion of the planned study, GEO-MVA is expected to advance toward regulatory submission and potential commercialization as an additional source of MVA vaccine supply for global preparedness and biodefense programs.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit www.geovax.com.

Forward-Looking Statements

This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.

Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Company Contact:

[email protected]

678-384-7220

Media Contact:

Jessica Starman

[email protected] 

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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Release – Ocugen Provides Business Update with First Quarter 2026 Financial Results

Posted on by [email protected]

Research News and Market Data on OCGN

May 5, 2026

PDF Version

Conference Call and Webcast Today at 8:30 a.m. ET

  • Positive 12-month data from the OCU410 Phase 2 ArMaDa clinical trial for geographic atrophy (GA) indicates a statistically significant (p<0.05) 31% reduction in lesion size and 27% EZ preservation (correlated to visual function) in optimal dose for Phase 3
    • About 20% of patients demonstrated no progression of disease and 75% of subjects showed > 30% reduction in Iesion growth compared to control, with a favorable safety and tolerability profile
    • Allows robust registrational Phase 3 trial design, a potential combined U.S./EU trial with 300 subjects, with adaptive design powered at over 95%
  • Trial enrollment complete for OCU400 for retinitis pigmentosa (RP) and OCU410ST for Stargardt disease registration trials, and on target to complete two Biologics License Application (BLA) submissions by 2027
  • The closing of a private offering of $115 million aggregate principal amount ($130 million if overallotment is exercised) of 6.75% convertible senior notes due 2034, with a conversion premium of 45%, is expected to extend cash runway into 2028, subject to customary closing conditions
    • The Company expects to utilize $32.7 million of net proceeds from the Notes to retire the Avenue debt (12.5% interest rate)

MALVERN, Pa., May 05, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today reported first quarter 2026 financial results along with a general business update.

With the recent offering, the Company is expected to have cash, cash equivalents, and restricted cash of $112.1 million, at closing, which includes the Avenue debt payoff. The Company will use the remaining net proceeds for general corporate purposes and expects to extend cash runway into 2028. The offering is expected to close on May 7, 2026, subject to customary closing conditions and includes an option to retire the debt with a cash payment. If the remaining Janus Henderson warrants are exercised, the Company will receive an additional $15 million in gross proceeds increasing expected cash, cash equivalents, and restricted cash to $127.1 million.

“In the first few months of 2026, we have completed enrollment of two of our late-stage programs and are diligently working toward initiating our first BLA submission for RP and registration trial for dry AMD later this year,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “We are executing well against our plans with the highest productivity per employee rate compared to our peers, adequate cash runway with the recent offering, and key milestone achievement to create long-term value creation for our patients and shareholders.”

Enrollment for liMeliGhT, the first and largest gene therapy registrational trial for broad RP patients (N=140), was completed, reflecting strong engagement from investigators and patients. The OCU400 Phase 3 clinical trial includes representation of a wide range of genetic mutations associated with early to advanced stages of clinical and/or genetic diagnosis of RP (over 25 genetic mutations), and patient response is intended to support the gene-agnostic mechanism of action of Ocugen’s novel modifier gene therapy platform. The Company plans to initiate the rolling BLA submission for OCU400 in the third quarter of 2026 and complete the BLA submission by the second quarter of 2027.

Manufacturing readiness for OCU400 is well underway and completion of process performance qualification (PPQ) batches remains on track for the second quarter of 2026. Approximately 300,000 people in the U.S. and Europe are living with RP, and OCU400 is intended as a treatment for early to advanced cases of RP, with potential approval in the fourth quarter of 2027.

GARDian3 clinical trial enrollment and dosing were completed ahead of schedule. GARDian3 is a multicenter, randomized, masked, pivotal Phase 2/3 confirmatory registration trial designed to evaluate the efficacy and safety of OCU410ST in patients with all mutations of Stargardt disease. The study enrolled 63 subjects diagnosed with Stargardt disease. Subjects randomized to the treatment group received a one-time subretinal injection of OCU410ST in the eye with poorer visual acuity, while the untreated control group did not receive any treatment. The primary endpoint is to evaluate the reduction in atrophic lesion size at 12 months. Key secondary endpoints include improvements in best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA), compared to controls. Observational endpoints include preservation of Ellipsoid Zone (EZ), which correlates to visual function. While demonstrating functional benefit via visual acuity within 12 months can be challenging due to the disease’s natural history, it is believed that preservation of EZ will serve as a meaningful and early indicator of visual function.

The interim outcome analysis of 24 subjects at 8 months post-OCU410ST (16 treated and 8 controls) is planned for the third quarter of 2026. Topline results are expected in the second quarter of 2027 with the BLA submission by mid-2027. Interim outcome analysis via adaptive design is typically introduced in pivotal trials to minimize risk. OCU410ST represents a potential first-in-class, one-time modifier gene therapy for all 100,000 patients in the U.S. and Europe with Stargardt disease.

Topline 12‑month data from the OCU410 Phase 2 ArMaDa clinical trial for geographic atrophy secondary to dry age-related macular degeneration was announced in March 2026 and demonstrates a statistically significant (p< 0.05) reduction in lesion growth (31%) versus control at 12 months with the optimal dose—medium dose—intended for Phase 3. The data suggest a potential 2X treatment benefit compared to 15% and 22% reductions reported for currently approved therapies at 12 and 24 months, respectively.

In the Phase 2 study, the safety and efficacy of OCU410 in patients with GA secondary to dAMD are being assessed. Fifty-one (51) patients aged 50 years and older with GA lesions within the foveal or non-foveal region were randomized 1:1:1 to receive a single subretinal administration of OCU410 at the medium dose, high dose, or no treatment in the control group. The primary endpoint was change in GA lesion size at 12 months, measured in square millimeters by fundus autofluorescence, an FDA-accepted structural endpoint used in recent GA registration trials. Exploratory endpoints included assessment of EZ preservation. The data showed no disease progression in approximately 20% of treated subjects, and 75% of treated subjects demonstrated greater than 30% reduction in lesion growth. The Company plans to initiate the OCU410 Phase 3 registrational trial in the third quarter of 2026 with potential BLA filing by 2028. As a potential one-time treatment for life, OCU410 could eliminate the treatment burden and patient fatigue with up to 40% drop-out rates reported with current approved therapies and provide a one-time solution for the 2-3 million patients in the U.S. and Europe with GA. OCU410 has potential to become a new standard of care for patients across the globe.

Executive leadership has participated in significant investor and industry conferences, including the U.S. Department of Commerce 2026 Certified Trade Mission to Singapore; Oppenheimer’s 3rd Annual Innovation on the Island Biotech Summit; and the 2026 Cell & Gene Meeting on the Mediterranean, hosted by the Alliance for Regenerative Medicine. Through these forums, Ocugen reached a wide audience and informed them about the importance of changing the treatment paradigm for blindness diseases by potentially bringing transformative modifier gene therapies to the masses.

“We are actively pursuing a variety of business development opportunities to prepare for global commercialization,” said Dr. Musunuri. “Potential commercial partnerships will allow us to effectively provide market access to patients who are in desperate need for rescue from blindness diseases globally while growing shareholder value.”

Business Updates

Novel Modifier Gene Therapy Platform—Targeting Three BLA Filings in the Next Three Years

OCU400

  • Completed Phase 3 liMeliGhT enrollment (N=140 subjects). Topline Phase 3 data expected in the first quarter of 2027, advancing OCU400 towards potential approval in the fourth quarter of 2027 as a treatment option for early- to late-stage RP.

OCU410ST

  • Early completion of enrollment and dosing—less than nine months—in the Phase 2/3 pivotal confirmatory trial (N=63 subjects). Plan to submit the BLA for OCU410ST by mid-2027.

OCU410

  • Announced positive 12-month topline data from the Phase 2 ArMaDa clinical trial. On track to meet with FDA/EMA to align on the Phase 3 study design and initiate Phase 3 by the third quarter of 2026.

Other Programs

OCU200

  • Completed Phase 1 clinical trial enrollment in the first quarter of 2026.

OCU500

  • NIAID intends to initiate the OCU500 Phase 1 clinical trial in the second quarter of 2026.

First Quarter 2026 Financial Results

  • The Company received $37.5 million in gross proceeds inclusive of $15 million, due to exercised warrants, in the first quarter of 2026. The Company’s cash, cash equivalents, and restricted cash totaled $32.2 million as of March 31, 2026, compared to $18.9 million as of December 31, 2025. With the recent offering, the Company is expected to have cash, cash equivalents, and restricted cash of $112.1 million, at closing, which includes the Avenue debt payoff.
  • The Company had 338.3 million shares of common stock outstanding as of March 31, 2026
  • Total operating expenses for the three months ended March 31, 2026 were $19.4 million and included research and development expenses of $11.3 million and general and administrative expenses of $8.1 million, compared to total operating expenses for the three months ended March 31, 2025 of $16.0 million that included research and development expenses of $9.5 million and general and administrative expenses of $6.5 million.
  • Ocugen reported a $(0.06) net loss per common share for the three months ended March 31, 2026 compared to a $(0.05) net loss per common share for the three months ended March 31, 2025.

Conference Call and Webcast Details
Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.

Attendees are invited to participate on the call or webcast 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 for approximately 45 days following the event 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, including, but not limited to, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, including the timing of enrollment and data readouts, the ability to initiate new clinical programs, Ocugen’s financial condition and expected cash runway into 2028, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, statements regarding potential market size and commercial possibilities of Ocugen’s product candidates, 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, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities; uncertainties related to whether the offering of the Notes will be completed on anticipated terms or at all; the impact of the offering of the Notes on the market price of the Company’s common stock; and risks related to the potential dilution to holders of the Company’s common stock. These and other risks and uncertainties are more fully described in our annual and 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:
Candice Masse
astr partners
[email protected]

View full release here.

Release – Ocugen, Inc. Announces Pricing of $115 Million of 6.75% Convertible Senior Notes

Posted on by [email protected]

Research News and Market Data on OCGN

May 5, 2026

PDF Version

MALVERN, Pa., May 05, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen”) (NASDAQ: OCGN) today announced the pricing of $115 million aggregate principal amount of 6.75% Convertible Senior Notes due 2034 (the “notes”) in a private offering (the “offering”) to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). Ocugen also granted the initial purchaser of the notes a 13-day option to purchase up to an additional $15 million aggregate principal amount of the notes. The sale of the notes to the initial purchaser is expected to close on May 7, 2026, subject to customary closing conditions, and is expected to result in approximately $99.5 million (or approximately $112.6 million if the initial purchaser exercises its option to purchase additional notes in full) in net proceeds to Ocugen after deducting the initial purchaser’s discount and estimated offering expenses payable by Ocugen.

The offering price of the notes is 90% of the principal amount of notes. Ocugen intends to use approximately $32.7 million of the net proceeds from the offering to fully repay the outstanding principal amount of, plus accrued and unpaid interest on, the loan outstanding under its Loan and Security Agreement with affiliates of Avenue Capital Group (the “Avenue Loan Agreement”), and pay the related prepayment fee and other fees and expenses in connection therewith. Ocugen expects to use the remaining net proceeds from the offering, including any additional proceeds from the initial purchaser’s exercise of its option to purchase additional notes, for general corporate purposes.

The notes will be Ocugen’s general unsecured obligations and will rank senior in right of payment to all of its future indebtedness that is expressly subordinated in right of payment to the notes, equal in right of payment to all of its existing and future liabilities that are not so subordinated, and junior to all of its secured indebtedness, to the extent of the value of the assets securing such indebtedness. Interest will be payable semi-annually in arrears. The notes will bear interest at a rate of 6.75% per year. Interest will be payable semi-annually in arrears on May 15 and November 15 of each year, beginning on November 15, 2026. The notes will mature on May 15, 2034, unless earlier repurchased, redeemed or converted.

Ocugen may not redeem the notes prior to May 15, 2029. Ocugen may redeem for cash all or any portion of the notes (subject to certain limitations), at its option, on or after May 15, 2029 and prior to the 41st scheduled trading day immediately preceding the maturity date, if the last reported sale price of Ocugen’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which Ocugen provides notice of redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. Holders of the notes may require Ocugen to repurchase for cash all or any portion of their notes on May 15, 2032 at a repurchase price equal to 100% of the principal amount of notes to be repurchased, plus accrued and unpaid interest to, but excluding May 15, 2032. In addition, holders of the notes will have the right to require Ocugen to repurchase all or a portion of their notes upon the occurrence of a fundamental change (as defined in the indenture governing the notes) at a purchase price of 100% of their principal amount plus any accrued and unpaid interest to, but excluding, the relevant fundamental change repurchase date.

The notes may not be converted prior to the earlier of (i) May 15, 2027 and (ii) the “reserved share effective date” (as defined in the indenture governing the notes), which is effectively the date on which Ocugen reserves the maximum number of shares of common stock underlying the notes. The notes will be convertible at an initial conversion rate of 372.7866 shares of Ocugen’s common stock per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $2.68 per share, which represents a conversion premium of approximately 45% to the last reported sale price of $1.85 per share of Ocugen’s common stock on The Nasdaq Capital Market on May 4, 2026). Conversions of the notes may be settled in cash, shares of Ocugen’s common stock, or a combination thereof, at Ocugen’s election; provided that unless and until the reserved share effective date occurs, conversions of the notes will be settled via cash settlement.

The notes were only offered to qualified institutional buyers pursuant to Rule 144A under the Securities Act. Neither the notes nor the shares of Ocugen’s common stock potentially issuable upon conversion of the notes, if any, have been, or will be, registered under the Securities Act or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States except pursuant to an applicable exemption from such registration requirements.

This announcement is neither an offer to sell nor a solicitation of an offer to buy any of these securities and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful.

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, including but not limited to, statements regarding the anticipated use of proceeds from the offering, including the repayment of the Avenue Loan Agreement; the completion of the offering, and other statements contained in this press release that are not historical facts. Ocugen 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 Ocugen’s current expectations, including, but not limited to: risks related to the offering and uncertainties related to market conditions; the impact of the offering on the market price of Ocugen’s common stock; and risks related to the potential dilution to holders of Ocugen’s common stock. These and other risks and uncertainties are more fully described in Ocugen’s 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 Ocugen files with the SEC. Any forward-looking statements that Ocugen makes in this press release speak only as of the date of this press release. Except as required by law, Ocugen assumes 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:

Candice Masse
astr partners
[email protected]

Release – Ocugen Announces Private Offering of $115 Million of Convertible Senior Notes

Posted on by [email protected]

Research News and Market Data on OCGN

May 4, 2026

PDF Version

MALVERN, Pa., May 04, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced its intention to offer, subject to market conditions and other factors, $115 million aggregate principal amount of Convertible Senior Notes due 2034 (the “notes”) in a private offering (the “offering”) to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). Ocugen also expects to grant the initial purchaser of the notes a 13-day option to purchase up to an additional $15 million aggregate principal amount of the notes. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Ocugen intends to use approximately $32.7 million of the net proceeds from the offering to fully repay the outstanding principal amount of, plus accrued and unpaid interest on, the loan outstanding under its Loan and Security Agreement with affiliates of Avenue Capital Group and pay the related prepayment fee and other fees and expenses in connection therewith. Ocugen expects to use the remaining net proceeds from the offering, including any additional proceeds from the initial purchaser’s exercise of its option to purchase additional notes, for general corporate purposes.

The notes will be Ocugen’s general unsecured obligations and will rank senior in right of payment to all of its future indebtedness that is expressly subordinated in right of payment to the notes, equal in right of payment to all of its existing and future liabilities that are not so subordinated, and junior to all of its secured indebtedness, to the extent of the value of the assets securing such indebtedness. Interest will be payable semi-annually in arrears. The notes may be converted into cash, shares of Ocugen’s common stock or a combination thereof, at Ocugen’s election. The interest rate, conversion rate and other terms of the notes are to be determined upon pricing of the offering.

The notes will only be offered to qualified institutional buyers pursuant to Rule 144A under the Securities Act. Neither the notes nor the shares of Ocugen’s common stock potentially issuable upon conversion of the notes, if any, have been, or will be, registered under the Securities Act or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States except pursuant to an applicable exemption from such registration requirements.

This announcement is neither an offer to sell nor a solicitation of an offer to buy any of these securities and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful.

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, including but not limited to, statements regarding the proposed terms of the notes; the anticipated terms of the notes; the size of the offering, including the initial purchaser’s option to purchase additional notes; the anticipated use of proceeds from the offering, including the repayment of the existing loan facility; the completion of the offering, and other statements contained in this press release that are not historical facts. Ocugen 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 Ocugen’s current expectations, including, but not limited to: uncertainties related to market conditions and whether the offering will be completed on the anticipated terms or at all; the impact of the offering on the market price of Ocugen’s common stock; risks related to the potential dilution to holders of Ocugen’s common stock; and uncertainties regarding the conversion price and other terms of the notes. These and other risks and uncertainties are more fully described in Ocugen’s 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 Ocugen files with the SEC. Any forward-looking statements that Ocugen makes in this press release speak only as of the date of this press release. Except as required by law, Ocugen assumes 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:

Candice Masse
astr partners
[email protected]

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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