Category: Health

Gyre Therapeutics, Inc (GYRE) – Gyre Reports 2Q26 Results Completes The Transformative Cullgen Acquisition

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Monday, August 10, 2026

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

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The Cullgen Acquisition Highlights 2Q26. Gyre reported a 2Q26 loss of $14.3 million, or $(0.12) per share. Revenues of $29.1 million compared with $22.5 million in 1Q26, consistent with our estimates. We have expected a transition year between Etuary market maturity and the expected hydronidone launch, supplemented by the Cullgen acquisition. Revenue guidance for FY2026 was reiterated at $100.5 to $111.0 million. Cash and equivalents on June 30, 2026 were $103.2 million.

Hydronidone NDA Accepted For Review. In May 2026, the New Drug Application (NDA) for hydronidone (previously F351) was accepted for review by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). This followed the Priority Review status granted by the NMPA in March.


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Gyre Therapeutics Reports Second Quarter 2026 and Year-to-Date Financial Results and Provides Business Update

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Research News and Market Data on GYRE

August 7, 2026

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Q2 2026 revenue of $29.1 million; GAAP basic EPS: $(0.12)

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

NDA for F351 (hydronidone) for CHB-induced liver fibrosis accepted by China’s CDE in May 2026

SAN DIEGO, Aug. 07, 2026 (GLOBE NEWSWIRE) — Gyre Therapeutics, Inc. (Gyre, Gyre Therapeutics or the Company) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company with operations in the United States and China, today announced financial results for the second quarter ended June 30, 2026, and provided a business update.

Dr. Ying Luo, President and Chief Executive Officer of Gyre Therapeutics, commented, “I am very pleased with Gyre’s progress over this last quarter, the highlights of which include the acquisition of Cullgen with its robust degrader pipeline and strong executive team, the NMPA acceptance of an NDA for F351 for CHB liver fibrosis, Gyre’s second major product candidate after ETUARY™, and increased sales from our Gyre Pharmaceuticals division, which demonstrates our commercialization capabilities.”

Second Quarter Business Highlights and Upcoming Milestones

Commercial Products:

ETUARYTM (pirfenidone), the Company’s primary product approved in China for idiopathic pulmonary fibrosis (IPF), generated $28.0 million in sales for the quarter ended June 30, 2026, compared to $23.5 million for the same period in 2025. EtorelTM (nintedanib ethanesulfonate soft capsules), which was launched in June 2025 and is indicated for systemic sclerosis-associated interstitial lung disease (SSc-ILD) and progressive pulmonary fibrosis (PPF), generated $0.3 million in sales for the quarter ended June 30, 2026 compared to $1.6 million for the same period in 2025. ContivaTM (avatrombopag maleate tablets), launched in March 2025 and indicated for thrombocytopenia in adults with chronic liver disease and immune thrombocytopenic purpura, generated $0.9 million in sales for the quarter ended June 30, 2026, compared to $1.5 million for the same period in 2025.

Pipeline Development Updates

F351 (hydronidone):

In May 2026, Gyre announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) accepted its New Drug Application (NDA) for F351 (hydronidone) as a treatment for chronic hepatitis B (CHB)-induced liver fibrosis. The acceptance came after Gyre submitted the NDA through its majority-owned subsidiary Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals) following the priority review status for F351 granted by the NMPA in March.

Pirfenidone (ETUARYTM):

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 by the fourth 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.

Dr. Luo added, “Following the close of our acquisition of Cullgen, we gained a portfolio of targeted protein degraders and degrader-antibody conjugates, while also expanding our pipeline into cancer, inflammatory diseases, cancer pain and solid tumors. We now have a full-spectrum pipeline consisting of clinical and IND-enabling assets to address multiple therapeutic areas with a focus on fibrosis and inflammatory diseases, plus a next-generation TPD/DAC platform to complement our legacy, commercial-stage fibrosis platform.  We believe the latter provides long-term upside, especially with our China-based innovation capabilities driving cost efficiencies for early-stage development.”

Cullgen Acquisition Closes in the Second Quarter of 2026

On May 4, 2026, Gyre Therapeutics acquired Cullgen Inc. (Cullgen) in an all-stock transaction valued at approximately $300 million and Cullgen became a wholly owned subsidiary of Gyre. Upon the closing of this transaction, Cullgen’s former Chief Executive Officer (CEO), Dr. Ying Luo, was appointed President and CEO of Gyre and joined Gyre’s Board. Additionally, Yue Xiong, former Chief Scientific Officer (CSO) of Cullgen, was appointed CSO of Gyre, Thomas Eastling, former Chief Financial Officer (CFO) of Cullgen, was appointed CFO of Gyre, and Ping Zhang was named Chairman. The combined company remains headquartered in San Diego with subsidiaries in Beijing and Shanghai, with roughly 740 employees, and numerous announced therapeutic programs spanning inflammation/pain and cancer.

The transaction has been accounted for as a transaction between entities under common control. Accordingly, the accompanying unaudited condensed consolidated financial statements have been retrospectively recast for all periods presented during which the Company and Cullgen were under common control to reflect the combined financial position and results of operations of the Company and Cullgen as if the common-control transfer had occurred at the beginning of the earliest period presented.

Updates on Programs in Development Following Cullgen Acquisition

CG001419 for cancer pain and solid tumors: Following the successful completion of a Phase 1 study in Australia of 78 healthy volunteers in December 2025, Gyre is now planning a Phase 2 study to further evaluate CG001419 in cancer-induced bone pain (CIBP) or other metastatic cancer pain syndromes.

CG001419 continues to separately be evaluated in a Phase 1 trial in China for the treatment of solid tumors.

CG009301 for AML:  The second product candidate from Cullgen, CG009301, is a GSPT1 Degrader for acute myeloid leukemia (AML), a fast-growing cancer of the blood and bone marrow.  This candidate continues to be studied in a Phase 1 dose-escalation trial being conducted in China in patients with high-risk hematologic malignancies.

Dual-degrader programs, next-generation TPDs: Gyre expects to submit Investigational New Drug (IND) applications in the United States and/or China in the first quarter of 2027 for two additional Cullgen degrader assets: CG923308, a CDK2-Cyclin E dual degrader for solid tumor indications, and CG620953, a TYK2-JAK1 dual degrader for autoimmune diseases.

DACs, next-generation ADCs: Additional candidates include degrader antibody conjugates (DACs), which are considered to be the next generation of antibody drug conjugates (ADCs), and which are in development to target both solid tumors and hematological malignancies by pairing distinct protein degraders with tumor-specific antibodies.

Financial Results

Cash Position

As of June 30, 2026, Gyre held $43.3 million in cash and cash equivalents, $14.1 million in short-term bank deposits, $17.5 million in short-term investment, and $28.4 million in long-term certificates of deposit, totaling $103.2 million. Compared to $116.1 million as of December 31, 2025, total cash decreased by $12.9 million, or 11%, primarily driven by a decrease in short-term investment of $10.6 million.

Financial Results for the Three Months Ended June 30, 2026

  • Revenues: Revenues for the three months ended June 30, 2026 were $29.1 million, compared to $29.7 million for the same period in 2025, representing a $0.6 million, or 2%, decrease. Gyre Pharmaceuticals revenue increased during the period, primarily driven by higher ETUARYTM sales volumes resulting from ETUARYTM focused marketing efforts, despite lower ContivaTM and EtorelTM product revenues earned following the implementation of China’s national centralized procurement program. The increase was offset by a $3.0 million decrease in collaboration revenue from the Collaboration, Option, and License Agreement with Astellas Pharma Inc. (the Astellas Agreement) which ended in March 2026, resulting in an overall decrease in revenues of $0.6 million, or 2%, compared to the prior-year period.
  • Cost of Revenues: For the three months ended June 30, 2026, cost of revenues was $2.2 million, compared to $1.2 million for the same period in 2025. The $1.0 million, or 92%, increase was primarily driven by a $0.7 million increase in production costs associated with EtorelTM products, a $0.2 million increase in production costs for ETUARYTM, and a $0.1 million increase in stock-based compensation expense.
  • Selling and Marketing Expense: For the three months ended June 30, 2026, selling and marketing expense was $13.8 million, compared to $15.2 million for the same period in 2025. The $1.4 million, or 9%, decrease was primarily attributable to a $2.5 million decrease in promotional and conference expenses as certain promotional objectives were achieved in the first quarter of 2026, reducing spending in the second quarter, partially offset by a $0.6 million increase in stock-based compensation expenses, and a $0.5 million increase in personnel-related costs, primarily due to increased sales commissions resulting from higher sales volumes during the second quarter of 2026.
  • Research and Development Expense: For the three months ended June 30, 2026, research and development expense was $19.1 million, compared to $8.4 million for the same period in 2025. The $10.8 million, or 129%, increase was primarily related to a $4.7 million increase in external clinical research expenses, mainly attributable to the F351 Phase 3C experimental review expense; a $4.8 million increase for the milestone payment Gyre Pharmaceuticals owed to GNI Group Ltd. (GNI) related to China’s NMPA acceptance of NDA for F351 as a treatment for CHB-induced liver fibrosis; a $0.7 million increase in pre-clinical expenses, and a $0.6 million increase in facilities, depreciation and other expenses.
  • General and Administrative Expense: For the three months ended June 30, 2026, general and administrative expense was $7.9 million, compared to $7.3 million for the same period in 2025. The $0.6 million, or 8%, increase was primarily driven by a $0.9 million increase in personnel costs related to the Company’s internal restructuring, and a $0.2 million increase in miscellaneous expenses, partially offset by a $0.2 million decrease in stock-based compensation expenses and a $0.3 million decrease in professional fees.
  • Transaction Costs: For the three months ended June 30, 2026, $0.5 million in transaction costs were incurred in connection with the acquisition of Cullgen closed in early May 2026.
  • Loss from Operations: For the three months ended June 30, 2026, loss from operations was $14.4 million, compared to loss from operations of $2.2 million for the same period in 2025. The $12.1 million increase was primarily driven by an increase in total operating expenses including transaction costs, increased stock-based compensation, expanded marketing expenses for EtorelTM and ContivaTM, and Phase 3C and other clinical trial and pre-clinical activities.
  • Net (Loss) Income: For the three months ended June 30, 2026, net loss was $14.3 million, compared to net loss of $2.2 million for the same period in 2025. The $12.0 million increase in net loss was primarily driven by an increase in operating expenses of $11.5 million, a decrease in other income of $0.7 million, and a decrease in revenue of $0.6 million, partially offset by a decrease in income tax expense of $0.8 million.
  • Non-GAAP Adjusted Net Income: For the three months ended June 30, 2026, non-GAAP adjusted net loss was $12.2 million, compared to non-GAAP adjusted net loss of $0.6 million for the same period in 2025. The $11.6 million decrease was primarily driven by an increase in operating expenses of $10.3 million, a decrease in other income of $0.7 million, and a decrease in revenue of $0.6 million.

Financial Results for the Six Months Ended June 30, 2026

  • Revenues: Revenues for the six months ended June 30, 2026, were $53.5 million, compared to $60.3 million for the same period in 2025, resulting in a $6.8 million decrease. Revenue from Gyre Pharmaceuticals increased during the period, primarily driven by higher ETUARYTM sales volumes resulting from ETUARYTM focused marketing efforts, despite lower ContivaTM and EtorelTM product revenues following the implementation of China’s national centralized procurement program. The overall increase in revenue from Gyre Pharmaceuticals was offset by a $9.6 million decrease in collaboration revenue under the Astellas Agreement which ended in March 2026.
  • Cost of Revenues: For the six months ended June 30, 2026, cost of revenues was $3.4 million, compared to $2.0 million for the same period in 2025. The $1.4 million increase was primarily driven by higher EtorelTM product costs of $1.1 million and increased stock-based compensation expense of $0.3 million.
  • Selling and Marketing Expense: For the six months ended June 30, 2026, selling and marketing expense was $27.9 million, compared to $26.0 million for the same period in 2025. The $1.9 million increase was primarily attributable to a $1.6 million increase in stock-based compensation expense, and a $0.4 million increase in promotional and conference expenses, partially offset by a $0.1 million decrease in travel and other expense.
  • Research and Development Expense: For the six months ended June 30, 2026, research and development expense was $30.6 million, compared to $16.4 million for the same period in 2025. The $14.2 million increase was primarily related to an $8.9 million increase in external clinical research expenses, mainly attributable to the F351 Phase 3C experimental review expense; a $0.4 million increase in personnel-related expenses including stock-based compensation expenses, a $4.8 million increase for the milestone payment Gyre Pharmaceuticals owed to GNI related to China’s NMPA acceptance of NDA for F351 as a treatment for CHB-induced liver fibrosis; a $0.5 million increase in pre-clinical expenses, and a $0.4 million increase in materials and utilities expenses, partially offset by a $0.8 million decrease in facilities, depreciation and other expenses.
  • General and Administrative Expense: For the six months ended June 30, 2026, general and administrative expense was $18.0 million, compared to $15.4 million for the same period in 2025. The $2.6 million increase was primarily driven by a $2.7 million increase in personnel costs related to the Company’s internal restructuring, a $0.9 million increase in miscellaneous expenses, a $0.6 million increase in stock-based compensation expenses, partially offset by a $1.6 million decrease in professional fees.
  • Transaction Costs: For the six months ended June 30, 2026, $3.8 million in transaction costs were incurred in connection with the termination of proposed merger between Cullgen and Pulmatrix, Inc. in February 2026 and $3.1 million were incurred related to the acquisition of Cullgen, which transaction closed in early May 2026, totaling $6.9 million.
  • (Loss) Income from Operations: For the six months ended June 30, 2026, loss from operations was $33.3 million, compared to $0.3 million income from operations for the same period in 2025. The $33.6 million decrease was primarily driven by an increase in total operating expense including transaction costs, increased stock-based compensation, expanded marketing expenses for EtorelTM and ContivaTM, and Phase 3C and other clinical trial and pre-clinical activities.
  • Net (Loss) Income: For the six months ended June 30, 2026, net loss was $32.8 million, compared to $2.7 million net income for the same period in 2025. The $35.6 million increase was primarily driven by an increase in operating expenses of $26.9 million, a decrease in other income of $3.1 million, and a decrease in revenue of $6.8 million, partially offset by a decrease in income tax expense of $1.2 million.
  • Non-GAAP Adjusted Net (Loss) Income: For the six months ended June 30, 2026, non-GAAP adjusted net loss was $21.1 million, compared to $3.7 million non-GAAP adjusted net income for the same period in 2025. The decrease was primarily driven by an increase in operating expenses of $17.2 million, a decrease in other income of $0.8 million, and a decrease in revenue of $6.8 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, provision for income taxes, transaction costs and loss on disposal of assets, net. 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: 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 is further analyzing China Phase 3 study results of F351, together with new pre-clinical results obtained to determine an optimal regulatory path for Phase 2 studies in MASH fibrosis.

About Gyre Pharmaceuticals

Gyre Pharmaceuticals Co., Ltd., a subsidiary of Gyre Therapeutics, Inc., is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY™ (pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share over the past several years. In addition, Gyre Pharmaceuticals’ pipeline includes F351 (hydronidone), a structural analogue of pirfenidone, which demonstrated statistically significant fibrosis regression after 52 weeks of treatment in a pivotal Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC. In May 2026, China’s National Medical Products Administration (NMPA) accepted Gyre Pharmaceuticals’ New Drug Application (NDA) for F351 as a treatment for CHB-induced liver fibrosis, which is liver damage resulting from the infection of the hepatitis B virus (HBV). 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, chronic obstructive pulmonary disease (COPD), pulmonary arterial hypertension (PAH) and acute/acute-on-chronic liver failure (ALF/ACLF). As of June 30, 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 DAC therapies for critical conditions including cancer and inflammatory diseases. Cullgen has created a portfolio of highly selective targeted protein degrader and DAC product candidates designed to potently and efficiently eliminate therapeutically relevant proteins in patients.

Forward-Looking Statements

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

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

Contact:

Gyre Therapeutics, Inc.

Thomas Eastling, CFO
[email protected]

Investors

Chuck Padala
Managing Director, LifeSci Advisors
[email protected]

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Ocugen (OCGN) – Q2 2026 Reported With Three Late-Stage Trials Advancing With A Stronger Balance Sheet

Posted on by [email protected]


Friday, August 07, 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.

Ocugen Raised Cash and Prepared To Begin Phase 3. Ocugen reported a 2Q26 loss of $24.9 million, or $(0.07) per share. The Operating Loss of $16.4 million was in line with our estimate, while a Loss on Extinguishment of Debt contributed $2.4 million to the Net Loss. Importantly, the company is planning to start the Phase 3 trial for OCU410 in GA-dAMD during 3Q, consistent with our expectations. In May 2026, the company issued Convertible Notes that raised approximately $112.5 million, ending the quarter with $100.4 million in cash.

Convertible Notes Balance Cash Needs With Dilution. In May 2026, the company issued $130.0 million in 6.75% Convertible Notes, adding net cash of approximately $112.5 million. About $32.7 million of the proceeds were used to repay a  12.25% interest loan. The remaining proceeds brought cash on hand to $100.4 million. This should provide sufficient cash to fund its three products through clinical trials, regulatory approval, and product launches through FY2028.


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Release – NeuroSense Completes PrimeC Pre-NDS Process and Advances Toward December 2026 Filing with Health Canada

Posted on by [email protected]

Research News and Market Data on NRSN

Final meeting minutes reflect alignment with Health Canada on the planned content and structure of the ALS submission

CAMBRIDGE, Mass., Aug. 6, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense”), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced that it is targeting December 2026 for the filing of a New Drug Submission (“NDS”) with Health Canada for PrimeC, its lead therapeutic candidate for amyotrophic lateral sclerosis (“ALS”).

The filing target follows the successful finalization of the Pre-NDS process with Health Canada and the associated meeting minutes. The discussions with Health Canada provided alignment regarding the content and structure of the submission. Health Canada has also indicated that it has no concerns with the Company’s proposed filing timeline and advised the Company to target early December.

NDS is the Canadian equivalent of a New Drug Application (NDA) in the United States. Following the successful completion of the Pre-NDS process, the application will undergo an administrative screening and, if accepted for review, a comprehensive scientific evaluation. Health Canada’s target review timeline for a standard NDS is approximately 300 days following acceptance for review.

“We now have an alignment with the Canadian regulator and a clear operational target,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “Our team is advancing the remaining clinical, biomarker, manufacturing and regulatory components of the NDS, with the objective of filing in December 2026. Canada represents an important potential market for PrimeC and, more importantly, an opportunity to bring a promising therapy to people living with ALS.”

Significant need for additional ALS treatments in Canada

Based on publicly reported Canadian data1, over 3,000 Canadians are currently living with ALS, and approximately 1,000 Canadians are diagnosed with the disease each year. Given the limited treatment options available and their modest clinical benefit, ALS remains a progressive and fatal neurodegenerative disease with substantial unmet medical need.

Health Canada-approved treatments for the broad ALS population include riluzole and edaravone. Based on the publicly reported Canadian list price assessed by the Canadian Agency for Drugs and Technologies in Health, now Canada’s Drug Agency, oral edaravone carries an estimated annual drug-acquisition cost of approximately C$120,000 (approximately US$85,000) per patient. Actual prices paid by public drug plans may differ because of confidential pricing arrangements and negotiated rebates.

NeuroSense believes these market dynamics underscore both the considerable healthcare burden associated with ALS and the need for additional therapies capable of meaningfully affecting disease progression and survival.

PrimeC clinical evidence

The planned NDS will be supported by the totality of evidence generated through NeuroSense’s Phase 2b PARADIGM clinical program, including:

  • Achievement of the study’s prespecified primary TDP-43 biomarker endpoint;
  • Long-term clinical outcomes demonstrating consistent effects on ALSFRS-R decline;
  • Statistically significant ~15-month median survival benefit (HR 0.35, p=0.0037);
  • Consistent findings across PrimeC’s multi-pathway biomarker program; and
  • A favorable safety and tolerability profile during extended treatment and follow-up.

NeuroSense is progressing the Canadian NDS in parallel with preparations for PARAGON, its confirmatory Phase 3 clinical study of PrimeC in ALS.

About NeuroSense

NeuroSense Therapeutics is a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease. The Company’s lead product candidate, PrimeC, is a novel oral therapy designed to target multiple key biological pathways underlying disease progression, including neuroinflammation, oxidative stress and dysregulated iron metabolism.

NeuroSense has recently completed analysis of long-term follow-up data from its Phase 2b PARADIGM study in ALS, supporting meaningful slowing of disease progression. The Company also reported significant biological activity across multiple biomarkers associated with ALS, including microRNAs, supporting PrimeC’s multi-target mechanism of action and representing a potentially important advance in the treatment of ALS.

NeuroSense has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a pivotal Phase 3 clinical trial (PARAGON) in ALS, which is expected to enroll approximately 300 participants, primarily in the United States.

For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.

About PrimeC

PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to target several key mechanisms that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation, with the potential to inhibit disease progression.

About ALS

Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of the filing of the NDS with Health Canada for PrimeC, the timing of review by Health Canada of the NDS and the commercial potential of PrimeC. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include risks of delay in the planned filing of the NDS with Health Canada; the risk of delay in the review by Health Canada of the NDS; the risk that Health Canada will not approve the NDS; the uncertainty regarding the commercial potential of PrimeC; uncertainty regarding outcomes and the timing of current and future clinical trials; the risk that PrimeC will not advance towards later-stage development, timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 31, 2026 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

1 https://news.ontario.ca/en/release/1003213/ontario-first-in-canada-to-provide-coverage-for-new-als-treatment?utm_source=chatgpt.com

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SOURCE NeuroSense

For further information: For further information: Email: [email protected] | Tel: +972 (0)9 799 6183

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

Posted on by [email protected]

Research News and Market Data on OCGN

August 6, 2026

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

  • Received U.S. Food and Drug Administration (FDA) clearance to initiate OCU410 Phase 3 trial for geographic atrophy (GA), secondary to dry age-related macular degeneration (AMD); on track to initiate Phase 3 this quarter
  • Granted Regenerative Medicine Advanced Therapy (RMAT) designation by FDA for OCU410, enabling eligibility for priority review and accelerated approval
  • Signed a binding term sheet with Roots Pharmaceutical, and its strategic partner Al-Dhow International Holding, to negotiate an exclusive license for OCU400 in retinitis pigmentosa (RP) across the Middle East and North Africa (MENA) region
  • Successfully completed OCU400 Process Performance Qualification (PPQ) batches, supporting Biologics License Application (BLA) and commercial launch supplies
  • Closed $130.0 million convertible senior notes financing, extending cash runway into 2028
  • Remain on track to announce top-line results for two late-stage clinical programs, OCU400 for RP and OCU410ST for Stargardt disease in 1Q 2027 and 2Q 2027, respectively
  • Strengthened leadership team with the appointments of Mohamed Genead, M.D., M.Sc., as Chief Medical Officer and Chris Clark as Head of Corporate Communications

MALVERN, Pa., Aug. 06, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today reported second quarter 2026 financial results along with a general business update.

“The second quarter of 2026 marked a pivotal inflection point for Ocugen. We closed $130 million convertible senior notes financing, extending our cash runway into 2028, and signed a binding term sheet for exclusive license of OCU400 in retinitis pigmentosa across the Middle East and North Africa region,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “Ocugen is a leading gene therapy company, focused on vision loss diseases with significant unmet medical needs, with multiple catalysts through 2028 across three distinct retinal disease indications. As we advance toward key data milestones in the first half of 2027, we remain focused on creating long-term value for our patients and shareholders.”

Unlike traditional gene therapies that correct a single mutation, Ocugen’s modifier gene therapy platform targets master regulatory genes that control multiple gene networks of biological pathways, supporting a gene-agnostic approach applicable across a broad range of genetic mutations, as well as diseases with complex pathways such as dry AMD. This allows the Company to address large, underserved patient populations rather than narrow single-gene subsets. This platform underpins each of Ocugen’s three late-stage programs, which advanced meaningfully during the quarter.

Clinical Program Updates

OCU410 (GA)

  • Received FDA clearance for the Phase 3 registrational trial (ArMaDa3) for GA secondary to dry age-related macular degeneration, anchored by positive 12-month Phase 2 ArMaDa data (statistically significant 31% reduction in GA lesion growth versus control [patient population: lesion size ≥2.5 mm2 and ≤17.5 mm2], p<0.05, at the optimal dose planned for Phase 3)
  • Planned combined global Phase 3 trial of approximately 237 subjects powered at 95% for primary end point on track to initiate this quarter, with BLA and MAA filings targeted for 2028
  • Granted Regenerative Medicine Advanced Therapy RMAT designation by FDA, enabling eligibility for priority review and accelerated approval
  • GA affects approximately 2 to 3 million people in the U.S. and Europe

OCU410ST (Stargardt disease)

  • Completed enrollment and dosing of 63 subjects ahead of schedule, in less than nine months, in the pivotal Phase 2/3 GARDian3 trial evaluating OCU410ST in patients with all mutations of Stargardt disease
  • Topline results anticipated in the second quarter of 2027, with a BLA submission to follow mid-2027
  • Holds Orphan Drug and Rare Pediatric Disease Designations from the FDA and Orphan Medicinal Product Designation and Advanced Therapy Medicinal Product classification from the EMA
  • Stargardt disease affects approximately 100,000 patients across the U.S. and Europe, with no approved therapies globally

OCU400 (RP)

  • Completed enrollment in liMeliGhT (N=140), the first and largest genetic medicine registrational trial for broad RP patients, spanning more than 30 genetic mutations
  • FDA feedback confirmed that the path to rolling BLA submission remains tied to topline data expected in the first quarter of 2027, and the company is advancing preparation accordingly, including successfully completing Process Performance Qualification (PPQ) batches
  • Approximately 300,000 people in the U.S. and Europe are living with RP

Corporate Updates

  • Closed the offering of $130.0 million aggregate principal amount of 6.75% Convertible Senior Notes due 2034, including the full exercise of the $15.0 million over-allotment option, for net proceeds of approximately $112.5 million
    • Approximately $32.7 million of net proceeds was used to fully retire the Avenue Capital loan, eliminating 12.25% interest-rate debt from the Company’s capital structure
    • The offering extends Ocugen’s cash runway into 2028
  • Signed a binding term sheet with Roots Pharmaceutical to negotiate an exclusive OCU400 license in the MENA region, with up to $255 million in sales milestones and a 22% royalty on net sales, as well as moderate upfront payment to Ocugen
  • Ocugen appointed two new members to its leadership team
    • Mohamed Genead, M.D., M.Sc., was named Chief Medical Officer on June 11, 2026. Dr. Genead is an ophthalmologist and retina specialist with more than 20 years of experience in ophthalmology and gene therapy, having previously served as Co-Founder and Chief Executive Officer of Aviceda Therapeutics and in senior leadership roles at GenSight Biologics, Biogen, and Allergan
    • Chris Clark was named Vice President, Corporate Communications on July 16, 2026. He has more than 20 years of communications and investor relations experience in the pharmaceutical and biopharmaceutical industries, having held leadership positions at Bausch + Lomb, Idorsia Pharmaceuticals, and Pfizer, as well as communications and investor relations roles at Novo Nordisk, Bristol Myers Squibb, Endo Pharmaceuticals, and Johnson & Johnson

Second Quarter 2026 Financial Results

  • The Company’s cash, cash equivalents, and restricted cash totaled $100.4 million as of June 30, 2026, compared to $32.2 million as of March 31, 2026.
  • The Company had 339.0 million shares of common stock outstanding as of June 30, 2026.
  • Total operating expenses for the three months ended June 30, 2026, were $17.9 million and included research and development expenses of $10.7 million and general and administrative expenses of $7.2 million, compared to total operating expenses for the three months ended June 30, 2025, of $15.2 million that included research and development expenses of $8.4 million and general and administrative expenses of $6.8 million.
  • Ocugen reported a $0.07 net loss per common share for the three months ended June 30, 2026, compared to a $0.05 net loss per common share for the three months ended June 30, 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.

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 using the following details:

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 2222566
Webcast: Available on the events section of the Ocugen investor site

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

About Ocugen, Inc.
Ocugen, Inc. is a pioneering biotechnology company developing gene therapies for blindness diseases. The Company’s breakthrough modifier gene therapy platform has the potential to address significant unmet medical needs across large patient populations through a gene-agnostic approach. Unlike traditional gene therapies and gene-editing technologies that target a single gene mutation, Ocugen’s modifier gene therapies are designed to address the underlying disease biology by restoring balance across multiple gene networks. The Company is currently advancing programs for inherited retinal diseases and other causes of blindness that affect millions worldwide, including retinitis pigmentosa, Stargardt disease, and geographic atrophy, an advanced form of dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on LinkedIn and X.

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 may not be predictive of the results or success of later clinical trials; and that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. 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.

Contacts:

Investors:
Candice Masse
astr partners
[email protected]

Media:
Chris Clark
[email protected]

View full release here.

Tarsus Pays $450 Million for a Drug That Won’t Have Data Until 2029

Posted on by [email protected]

Tarsus Pharmaceuticals (Nasdaq: TARS) announced Thursday it has entered into a definitive agreement to acquire privately held Alkeus Pharmaceuticals, adding gildeuretinol, an investigational once-daily oral therapy for Stargardt disease, to its growing eye care pipeline. Under the terms of the agreement, Tarsus will pay approximately $450 million upfront, including $270 million in cash, with up to $350 million in additional milestone payments and low-to-mid single digit royalties on future product sales.

Alongside the acquisition, Tarsus secured $125 million in gross proceeds through an oversubscribed private placement equity financing, giving the company additional capital to fund the integration and continued clinical development of its expanding pipeline. The deal is expected to close later in 2026, subject to customary closing conditions.

What Alkeus Brings to Tarsus

Stargardt disease is a rare, inherited retinal disorder that currently has no FDA-approved treatments, making it exactly the kind of high unmet need indication that commands significant strategic value despite years remaining before any potential approval. Gildeuretinol has already been studied in more than 400 individuals, demonstrating a favorable tolerability and efficacy profile, and has received both Breakthrough Therapy and Orphan Drug designations from the FDA, two regulatory signals that typically accelerate development timelines and reflect meaningful confidence in a drug’s underlying science.

The catch, and the reason this deal is genuinely a long-term bet, is timing. Topline data from the pivotal Phase 3 NORTHSTAR trial is not expected until the second half of 2029, meaning Tarsus is paying $450 million upfront for an asset that will not produce a definitive readout for roughly three more years.

A Pattern, Not a One-Off Deal

This is not Tarsus’s first eye care acquisition this year. The Alkeus deal builds directly on the company’s recent acquisition of iRenix Medical, which brought IRX-101, a potential ocular antiseptic, into the fold. Combined with its existing pipeline, which includes TP-04 for ocular rosacea and TP-05 for Lyme disease prevention, both currently in Phase 2, Tarsus is deliberately assembling one of the more comprehensive eye care pipelines in the industry rather than remaining a single-product company.

That strategy is being funded by genuine commercial strength. Tarsus reported second quarter 2026 net product sales of $173.9 million for its lead commercial product XDEMVY, an increase of more than 69% year over year, and raised its full-year 2026 XDEMVY sales guidance to a range of $685 million to $705 million. That accelerating commercial performance gives Tarsus the balance sheet flexibility to fund a multi-year pipeline bet like Alkeus while continuing to invest across its broader portfolio.

What It Means for Investors Tracking Ophthalmology and Rare Disease

For investors tracking small and mid cap companies in ophthalmology and inherited retinal disease, this transaction reinforces just how much strategic value the market continues to assign to differentiated science addressing conditions with no approved treatment options, even when the definitive clinical proof point sits years in the future. The broader inherited retinal disease space remains an area of active development, with companies like Ocugen continuing to advance gene therapy programs targeting similar categories of rare, previously untreatable retinal conditions.

Tarsus is betting that being the eye care company with the deepest pipeline, not just the strongest single product, is what builds durable value over the next decade. The market’s initial reaction, with shares pulling back modestly in premarket trading, suggests investors are still digesting the size of the bet relative to how far away the payoff actually is.

Lilly’s Quarter Confirmed It: Obesity Is Pharma’s Most Valuable Real Estate

Posted on by [email protected]

Eli Lilly jumped as much as 7% Wednesday after another quarter that made one thing clear: the appetite for weight-loss drugs isn’t slowing down. For small-cap investors, though, the trillion-dollar stock isn’t the story. What that demand does to the hunt for the next obesity drug is.

First, the quarter. Lilly raised its 2026 revenue forecast to a range of $85 billion to $87 billion, up from a prior ceiling near $85 billion, and beat on adjusted earnings — all powered by its GLP-1 franchise. It has momentum behind it, too: the FDA approved Foundayo, the pill version of its weight-loss drug, earlier this year, and next-generation candidate retatrutide is on track for an FDA filing early next year. The stock has climbed more than 40% since late April.

Here’s the read-through for the small end of the market.

Obesity is now the most valuable franchise in all of pharma, and the two giants that own it — Lilly and Novo Nordisk — are in a full sprint to stay ahead. That sprint runs straight through small-cap biotech. Building a differentiated metabolic drug from scratch is slow and uncertain; buying one that already has promising human data is faster. Big pharma has shown, again and again, that it will pay enormous premiums for early obesity and metabolic assets. Every small-cap sitting on a credible next-generation candidate — an oral GLP-1, an amylin, a muscle-sparing combination — is wearing a target because of quarters like this one.

There’s a second, quieter beneficiary: the supply chain. A demand curve this steep needs manufacturing, and that lifts the unglamorous names that make it possible — the peptide contract manufacturers, the auto-injector and drug-delivery specialists, and now the oral-formulation capacity that Foundayo’s approval just validated. It’s the same picks-and-shovels logic behind the bioprocessing consolidation we’ve watched all summer: when a therapy category explodes, the companies supplying the tools get pulled along, and often bought.

Now the discipline, because this is where enthusiasm gets expensive. Obesity biotech is binary and badly overcrowded. For every small-cap with a genuine shot at the next blockbuster, a dozen are running me-too molecules that will quietly fail in the clinic. And many of the credible names already trade on takeout hope, which means a chunk of the premium is baked in before any deal is announced. The filter is differentiated, de-risked clinical data — an asset the giants can’t easily replicate and would rather buy. Everything else is a lottery ticket.

The takeaway is simple. The mega-cap headline is demand. The small-cap opportunity is the arms race that demand is funding. Lilly’s quarter didn’t just reward Lilly shareholders — it reminded every deal team in pharma that owning the future of obesity may be cheaper to buy than to build. Watch the small-caps holding data the giants can’t ignore.

Supernus and Indivior Are Merging to Build a $2.2 Billion CNS Powerhouse

Posted on by [email protected]

Supernus Pharmaceuticals (Nasdaq: SUPN) and Indivior Pharmaceuticals (Nasdaq: INDV) announced Monday they have entered into a definitive agreement to combine in a tax-free, all-stock merger of equals, creating a new company focused entirely on central nervous system disease. The combined entity will be named Supernus, Inc., trade on the Nasdaq Global Market under the ticker SUPN, and be headquartered in Rockville, Maryland.

The transaction is expected to generate pro forma net revenue of approximately $2.2 billion and pro forma adjusted EBITDA of $888 million, alongside roughly $125 million in expected annual cost synergies. Closing is targeted for the fourth quarter of 2026, subject to shareholder and regulatory approvals, and the boards of both companies have unanimously approved the deal.

How the Merger Is Structured

The deal terms reveal a genuine merger of equals rather than a straightforward acquisition. Supernus stockholders will receive 1.5401 shares of Indivior common stock for each Supernus share they hold, resulting in Indivior stockholders owning approximately 56.5% of the combined company and Supernus stockholders owning approximately 43.5%, on a fully diluted basis.

Ahead of closing, Indivior stockholders will also receive a one-time special cash dividend totaling $1.0 billion. That dividend will be funded through a combination of existing cash on hand and a $650 million term loan facility committed by Citibank. Jack Khattar, currently President and CEO of Supernus, will lead the combined company in that same role, while Tony Kingsley, currently a member of Indivior’s board, will serve as Board Chair.

Two Complementary CNS Franchises Coming Together

The strategic logic centers on scale and portfolio diversification within neuroscience. Supernus has built its business around psychiatric and neurological conditions, while Indivior has focused heavily on addiction treatment. Together, the combined company will market 11 differentiated commercial medicines spanning psychiatry, neurology, and addiction, a breadth that neither company could offer independently at this scale.

That diversification matters strategically because CNS drug development is notoriously difficult, with high clinical failure rates and long development timelines. A combined commercial portfolio spanning multiple CNS subcategories reduces the company’s dependence on any single therapeutic area or product cycle, while giving it a broader sales and marketing infrastructure to support both existing products and future pipeline candidates.

A Financially Disciplined Combination

Alongside the merger announcement, Supernus also raised its fiscal 2026 sales guidance, moving its prior range of $1.215 billion to $1.285 billion up to a new range of $1.295 billion to $1.365 billion, above the consensus estimate of $1.245 billion, a signal of underlying business strength independent of the transaction itself.

The combined company is projected to carry net debt of roughly $878 million against its earnings base, translating to a net leverage ratio below 1 times EBITDA. That conservative balance sheet is a notable feature of the deal, giving the newly formed Supernus, Inc. meaningful financial flexibility to continue investing in its internal pipeline while also pursuing additional strategic acquisitions once the merger closes.

What It Means for Investors Tracking Specialty Pharma

For investors following small and mid cap pharmaceutical companies, this deal illustrates a consolidation pattern that continues to play out across specialty therapeutic areas. Two mid-sized companies, each strong in a narrower CNS niche, are combining to build the kind of commercial scale, balance sheet strength, and portfolio diversification that increasingly determines competitive positioning in specialty pharma, without either company needing to be acquired outright by a larger strategic buyer. The broader CNS space remains one of the more active areas of biopharmaceutical development, with clinical-stage companies like NeuroSense Therapeutics continuing to advance novel approaches to neurological disease even as larger, more established players consolidate around commercial scale.

Release – GeoVax Highlights Newly Published Independent Research Supporting Broader Filovirus Vaccine Strategies and Strategic Value of Its MVA-Based Vaccine Portfolio

Posted on by [email protected]
GeoVax

Research News and Market Data on GOVX

Recent Third-Party Research Reinforces Scientific Rationale for Evaluating Broad-Spectrum Filovirus Preparedness Approaches

ATLANTA, GA – August 3, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies for infectious diseases and solid tumors, today highlighted recently published independent scientific research that reinforces growing interest in vaccine strategies capable of providing broader protection across multiple ebolavirus species.

A recent independent study, discussed by MedPage Today (July 23, 2026) and released as a scientific preprint by independent investigators, reported that immune responses generated by licensed vaccines against Zaire ebolavirus (EBOV) recognized Bundibugyo ebolavirus (BDBV), an emerging ebolavirus species responsible for recent outbreaks in Central Africa. The investigators concluded that these findings support further evaluation of existing and next-generation vaccine strategies against Bundibugyo virus and other related filoviruses.

While the vaccines included in the study do not demonstrate protection against Bundibugyo virus, it provides additional scientific support for the concept that vaccine-induced immune responses may extend across related ebolavirus species and underscores the importance of developing broadly applicable filovirus vaccine platforms.

GeoVax has previously demonstrated significant protective efficacy in published non-human primate studies with separate Modified Vaccinia Ankara (MVA)-based vaccine candidates targeting both Zaire Ebola virus (EBOV) and Sudan Ebola virus (SUDV). Together with the Company’s Marburg virus vaccine program, these vaccine candidates comprise a differentiated filovirus vaccine portfolio built upon GeoVax’s proprietary MVA platform.

David A. Dodd, Chairman and Chief Executive Officer of GeoVax, commented: “Independent scientific validation plays an important role in advancing preparedness strategies for emerging infectious diseases. These newly reported findings reinforce the growing recognition that future outbreak preparedness will benefit from platform technologies capable of addressing multiple related pathogens rather than individual viruses. GeoVax has extensive institutional experience in developing MVA-based vaccines against several of the world’s highest-consequence filoviruses, and we believe our technology platform is well positioned to support future preparedness initiatives.”

Mark J. Newman, Ph.D., Chief Scientific Officer of GeoVax, added: “The recently published findings provide encouraging support for an important scientific hypothesis – that immune responses against one ebolavirus may extend to related viruses. GeoVax’s MVA-VLP, multi-antigen experimental vaccines, which have been evaluated in animal models and shown to provide significant protective efficacy, are designed to induce broadly protective immune responses, invoking both the antibody and cellular arms of the immune system. These independent findings demonstrate the potential of the GeoVax MVA-VLP platform.”

GeoVax’s filovirus vaccine portfolio currently includes vaccine candidates targeting:

  • Zaire Ebola virus (EBOV)
  • Sudan Ebola virus (SUDV)
  • Marburg virus (MARV)

Each program utilizes the Company’s Modified Vaccinia Ankara (MVA) platform, providing a common development and manufacturing foundation for addressing multiple high-consequence infectious diseases.

As governments and global health organizations continue strengthening preparedness against emerging infectious diseases, GeoVax believes platform technologies capable of supporting multiple biodefense and public health applications will become increasingly important.

The Company will continue evaluating strategic opportunities for its filovirus vaccine portfolio, including government collaborations, global health partnerships, and potential licensing opportunities, while maintaining its primary strategic focus on advancing GEO-MVA, its lead vaccine candidate for the prevention of mpox and smallpox, and Gedeptin®, its clinical-stage immuno-oncology program.

Reference

The scientific findings discussed in this release are based on recent independent research evaluating cross-reactive immune responses following licensed Ebola vaccination, as reported by MedPage Today (July 23, 2026) and described in a 2026 scientific preprint in The New England Journal of Medicine by the study investigators. GeoVax was not involved in conducting the study, and the findings should not be interpreted as demonstrating efficacy of GeoVax vaccine candidates against Bundibugyo ebolavirus.

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 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] 

Release – Cadrenal Therapeutics Solidifies Multi-Indication Strategy for CAD-1005 in Cardiac Acute Critical Care Following Competitor’s Phase 3 Discontinuation

Posted on by [email protected]

Research News and Market Data on CVKD

  • Urgent Need for Novel Targets – Recent clinical failure of a competing mechanism highlights urgent need for novel upstream targets, such as 12-LOX, that are being studied to address the root causes of cardio-renal injury
  • Dual-Indication Development and Commercialization Strategy Expands the Clinical Advancement of CAD-1005 to target both Heparin-Induced Thrombocytopenia (HIT) and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI)
  • Addresses High-Value Gap in the Acute Care Market -First-in-class positioning in the $1 billion+ U.S. CSA-AKI market following the recent discontinuation of a competitor’s late-stage Phase 3 clinical trial for lack of efficacy
  • Global Partnering Potential – Leverages shared in-hospital ICU infrastructure and intravenous (IV) presentation to deliver a critical care asset package

PONTE VEDRA, Fla., Aug. 03, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions, announced a consolidation of its multi-indication strategy for its Cardiac Acute Critical Care (CACC) Franchise, with a focus on CAD-1005 for both HIT and CSA-AKI.

Following a competitor’s recent Phase 3 failure in CSA-AKI, Cadrenal is highlighting the potential of its 12-LOX inhibitor to address a $1 billion+ market opportunity in this critical care space. CAD-1005 is being studied as a “Post-Operative Shield” that uses 12-lipoxygenase (12-LOX) inhibition intended to target platelet hyperactivation in HIT while simultaneously reducing inflammation-driven injury in patients with CSA-AKI. This dual-mechanism approach is supported by CAD-1005 clinical data presented last month at the International Society on Thrombosis and Haemostasis (ISTH) 2026 Congress in Paris. The late-breaking Phase 2 data for CAD-1005 demonstrated a compelling medical profile, with an absolute reduction in thrombotic events greater than 25% and a favorable safety and renal-protective baseline.

“The recent clinical failure of a competing late-stage mechanism highlights the urgent need for novel upstream targets, such as 12-LOX, that address the root causes of cardio-renal injury,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “This trial termination underscores the ongoing clinical challenge of identifying targeted pharmacologic strategies for the treatment of CSA-AKI, as no single drug class has yet demonstrated clear preventive efficacy for the condition. The company is actively pursuing strategic partnerships, including out-licensing or co-development, to leverage its transaction-ready, Phase 3-ready asset.

About CAD-1005
CAD-1005 is a novel investigational therapeutic in development for the treatment of heparin-induced thrombocytopenia (HIT) and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI). CAD-1005 is designed to selectively inhibit 12-lipoxygenase (12-LOX), an enzyme central to platelet immune activation and thrombo-inflammatory signaling in HIT. CAD-1005 is intended to be used alongside existing standards of care and is being developed to address the underlying biological mechanisms that drive disease progression. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA) and orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also being evaluated for chronic indications. To view how CAD-1005 is intended to work in patients with HIT, visit https://vimeo.com/1209382706/7dde06dc08?share=copy&fl=sv&fe=ci

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions. Its lead program, CAD-1005, is being investigated as a first-in-class 12-LOX inhibitor for the treatment of heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder, and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI). The Company’s Cardiac Acute Critical Care (CACC) portfolio also includes frunexian, an investigational intravenous Factor XIa inhibitor intended to provide anticoagulation for patients undergoing major cardiac surgery.

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 atrial fibrillation, those with left ventricular assist devices, and potentially those with Kawasaki disease (KD), an acute, self-limited, febrile illness that primarily affects children under 5 years old and is the leading cause of acquired heart disease in developed countries. The Company recently submitted a request for Rare Pediatric Disease Designation (RPDD) to the FDA for tecarfarin for “Prevention of the Formation of Life-Threatening Blood Clots Inside Coronary Artery Aneurysms in Children with Kawasaki Disease”. Tecarfarin has also received Orphan Drug and Fast Track designations from the FDA.

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 such as the ability of the Company’s Cardiac Acute Critical Care Franchise to address a crucial unmet need; the Company leveraging shared in-hospital ICU infrastructure and identical intravenous (IV) formulations to deliver a critical care asset package; the Company advancing specialized therapies for critical care cardiology and orphan cardiovascular conditions; the potential of CAD-1005 to address a $1B+ market gap; CAD-1005 potentially using 12-LOX inhibition to target platelet hyperactivation in HIT while simultaneously reducing inflammation-driven injury in patients with CSA-AKI; 12-LOX addressing the root causes of cardio-renal injury; identifying targeted pharmacologic strategies for the treatment of CSA-AKI; the company’s pursuit of strategic partnerships, including out-licensing or co-development, to leverage its Phase 3-ready asset; CAD-1005 addressing the underlying biological mechanisms that drive disease progression; the development of second-generation 12-LOX oral therapeutics for the treatment of chronic indications; frunexian potentially providing anticoagulation for patients undergoing major cardiac surgery; tecarfarin potentially treating patients requiring chronic anticoagulation, including those with end-stage kidney disease and atrial fibrillation, those with left ventricular assist devices, and potentially those with Kawasaki disease; and the FDA’s determination with respect to the Company’s request for RPDD for tecarfarin. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to advance specialized therapies for critical care cardiology and orphan cardiovascular conditions; the ability to enter into strategic partnerships, including out-licensing or co-development, to leverage its Phase 3-ready asset; the ability of CAD-1005 to address a $1B+ market gap; the ability of 12-LOX inhibition to target platelet hyperactivation in HIT while simultaneously reducing inflammation-driven injury in patients with CSA-AKI; the ability of 12-LOX to address the root causes of cardio-renal injury; the ability to develop second-generation 12-LOX oral therapeutics for the treatment of chronic indications; the ability of frunexian to provide anticoagulation for patients undergoing major cardiac surgery; the ability of tecarfarin to treat patients requiring chronic anticoagulation, including those with end-stage kidney disease and atrial fibrillation, those with left ventricular assist; the ability of the Company to raise sufficient capital to continue the clinical development of its product candidates; 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, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

For more information, please contact:

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

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Release – Cocrystal Pharma Announces $5 Million Private Placement with OPKO Health

Posted on by [email protected]
Cocrystal Pharma, Inc.

Research News and Market Data on COCP

August 03, 2026

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Longtime investor OPKO Health increases its position as Cocrystal advances toward norovirus Phase 1b data in late 2026

BOTHELL, Wash., Aug. 03, 2026 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), a biotechnology company developing novel antiviral therapeutics, today announced a $5 million investment from OPKO Health, Inc. (Nasdaq: OPK) (“OPKO”), a longtime investor in the Company, has increased its position through a $5 million investment as the Company advances its lead norovirus program toward Phase 1b topline data later this year.

Under the terms of the agreement, Cocrystal sold 5,474,053 shares of its common stock to OPKO at a price per share of $0.9134, the Nasdaq Consolidated Bid Price on the trading day of closing, for proceeds to the Company of $5.0 million. No warrants or other derivative securities were included in the transaction.

“OPKO’s increased investment reflects the confidence of one of our most steadfast supporters as we approach a defining moment for Cocrystal,” said James Sapirstein, Chief Executive Officer of Cocrystal Pharma. “We expect to report topline data from our Phase 1b norovirus trial by the end of the fourth quarter of 2026, and we’re grateful for OPKO’s continued conviction in the value of our lead asset, CDI-988, and our broader antiviral pipeline spanning influenza, coronaviruses and hepatitis C.”

“As a longtime investor in Cocrystal, we’ve watched the Company build a differentiated antiviral platform with real clinical potential,” said Dr. Phillip Frost, Chairman and Chief Executive Officer of OPKO Health and co-founder, director and principal stockholder of the Company. “This additional investment reflects our continued conviction in Cocrystal’s science and its path forward.”

About the Offering

The unregistered securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and Regulation D promulgated thereunder and have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities, nor will there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication of noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2), and hepatitis C viruses. The Company’s lead program, CDI-988, is currently in a Phase 1b clinical trial for norovirus, with topline data expected in late 2026. Cocrystal employs unique structure-based technologies to create differentiated antiviral drug candidates. For more information, visit www.cocrystalpharma.com.

About OPKO Health, Inc.

OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the private placement, the Company’s progress, anticipated timeline and expectations for topline data from its norovirus Phase 1b clinical trial, and the continued development of its influenza, coronaviruses, and hepatitis C, and other antiviral programs and the results thereof. Words such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” and “expect,” as they relate to the Company, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from inflation, affordability, the possibility of a recession, increases or other developments with respect to interest rates, uncertainty surrounding the impacts arising from imposed and threatened tariffs and developments with respect thereto, and wars and geopolitical conflicts including those in Ukraine and with Iran on our Company, our collaboration partners, and on the U.S. and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials and test subjects, including animals as well as similar problems with our vendors our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, risks arising from research into a related virus that was not done in animals and was necessarily early stage, the results of the Phase 1b clinical trial and future preclinical and clinical trials including the potential for adverse findings, general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes and potential litigation challenging initiatives and actions taken by the Trump Administration which could, among other things, result in delays in regulatory approvals or limit access to federal funding for our programs, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government, potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop, and our liquidity and ability to raise necessary capital on acceptable terms or at all. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
Nic Johnson
Russo Partners
[email protected]
(303) 482-6405

Media Contact:
David Schull
Russo Partners
[email protected]
(858) 717-2310

MiMedx Is Buying Sanara MedTech for $350 Million to Nearly Double Its Surgical Business

Posted on by [email protected]

MiMedx Group (Nasdaq: MDXG) and Sanara MedTech (Nasdaq: SMTI) announced Wednesday they have entered into a definitive merger agreement under which MiMedx will acquire all outstanding shares of Sanara in a cash and stock transaction valued at $35 per share, implying a total enterprise value of approximately $350 million. Sanara shareholders will receive $33.00 in cash plus 0.4735 shares of MiMedx common stock for each share owned, a combination representing a 46% premium to Sanara’s 30-day volume-weighted average price. The boards of both companies have unanimously approved the transaction, with closing expected by the end of 2026.

MiMedx plans to fund the cash portion of the deal through existing cash on hand alongside a new $300 million term loan secured with Hayfin Capital Management. The company’s existing credit agreement will be terminated and repaid in full at closing.

What Sanara Brings to the Table

Sanara MedTech is focused entirely on developing and commercializing regenerative products for surgical markets, an area MiMedx has identified as its primary strategic growth priority. Sanara contributes more than $100 million in surgical revenue along with a high-margin, 510(k)-cleared product portfolio, meaningfully expanding MiMedx’s presence in a segment where the company was already seeing meaningful traction on its own. MiMedx’s Surgical product sales grew 15% year over year in the second quarter to $39.3 million, driven by strength in its AmnioFix and AmnioEffect product lines along with early contributions from newer offerings.

Once combined, management expects the transaction to nearly double MiMedx’s surgical revenue and push combined company revenue above $400 million, with an adjusted EBITDA margin target above 20%. The deal is expected to be immediately accretive to revenue growth, gross margin, and adjusted EBITDA margin, and management anticipates more than $20 million in run-rate cost synergies.

The Balance Sheet Behind the Deal

The acquisition arrives alongside MiMedx’s second quarter results, which showed net sales of $64 million and a net loss of $14.8 million for the period. Despite that quarterly loss, the company ended the quarter with $135.8 million in cash and $119 million in net cash, and it reiterated full-year 2026 net sales guidance of $260 million to $290 million on a standalone basis. MiMedx also completed a cost reduction program targeting approximately $40 million in annualized savings and repurchased 3.5 million shares for roughly $13 million during the quarter, signaling a company managing its existing operations tightly even while pursuing a transformational acquisition.

Why This Matters for Small Cap Medtech Investors

For investors tracking regenerative medicine and surgical device companies in the small cap space, this deal reflects a broader consolidation pattern taking hold across specialized medtech niches. Companies with focused, high-margin surgical product portfolios but limited standalone scale are increasingly attractive targets for larger platforms looking to build a genuinely differentiated position across surgical subspecialties rather than compete purely on breadth. MiMedx is explicitly betting that combining two complementary regenerative medicine portfolios creates more value together than either company could generate independently, and the debt-financed structure of the deal signals real conviction in that combined growth trajectory.

Ocugen (OCGN) – OCU410 Granted RMAT Designation in Geographic Atrophy

Posted on by [email protected]


Thursday, July 30, 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.

RMAT Designation Brings Regulatory Advantages For OCU410. Ocugen announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to OCU410 for Geographic Atrophy secondary to Age-Related Macular Degeneration (GA-AMD). The RMAT designation was granted after FDA evaluation of Phase 2 data and provides significant benefits, including Fast Track and Breakthrough Therapy designations.

RMAT Designation Carries Benefits During Clinical Development. The RMAT designation is granted to drugs that address a serious condition with significant unmet need. There are several benefits, including more frequent FDA communications and guidance during clinical trials and the BLA process. This increased FDA contact could allow Ocugen to address development questions earlier, reducing regulatory uncertainty and streamlining the review.


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