OCGN Clinical trials

Ocugen, Inc. Announces Positive Scientific Advice from the European Medicines Agency Related to the Approval Pathway for OCU410ST—Modifier Gene Therapy for Stargardt Disease

Published August 13, 2025 at 10:27 AM

MALVERN, Pa., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) reviewed the study design, endpoints and planned statistical analysis of the ongoing pivotal confirmatory OCU410ST Phase 2/3 GARDian3 clinical trial for Stargardt disease and provided acceptability of a single U.S.-based trial for submission of a Marketing Authorization Application (MAA).

Related Questions

What are the projected revenues and market share for a potential OCU410ST approval in the European market? What is the expected impact on Ocugen’s earnings guidance for 2025‑2026 due to this regulatory milestone? How will the EMA's acceptance of a single US‑based trial affect the timeline for a Marketing Authorization Application (MAA) and potential launch date? What is the anticipated impact on Ocumen's share price in the short‑term and long‑term following this regulatory update? How does the GARDian3 trial's design, endpoints, and statistical analysis compare to those of competing gene therapies for retinal diseases? What are the key milestones and expected dates for the Phase 2/3 trial’s interim and final data readouts? What is the likelihood that the EMA will grant full approval after the single US trial, and what are the potential regulatory hurdles remaining? How does this regulatory development affect Ocugen’s cash burn rate and need for additional financing? What is the size and growth rate of the Stargardt disease market in Europe versus the US, and how does this compare to competitors’ pipelines? What potential pricing and reimbursement strategies could be employed for OCU410ST in Europe? How might this news affect Ocugen's partnerships, licensing agreements, or potential acquisition interest? What are the risks of relying on a single trial for MAA submission, and how could that influence investor confidence? How does the EMA’s feedback on study design impact the likelihood of successful FDA approval in the United States? What are the potential impacts on existing and upcoming clinical trial timelines for other Ocugen gene therapy programs? How might this EMA decision influence the stock’s volatility and trading volume in the next weeks?