MALVERN, Pa., June 16, 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 U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) amendment to initiate a Phase 2/3 pivotal confirmatory trial of OCU410ST, a modifier gene therapy candidate being developed for all Stargardt disease (ABCA4-associated retinopathies). The FDA previously granted Rare Pediatr ...

Ocugen (OCGN) Q1 2025 Earnings Call May 09, 2025 08:30 AM ET Company Participants Tiffany Hamilton - AVP & Head of Corporate CommunicationsShankar Musunuri - Co-Founder, CEO & ChairmanRamesh Ramachandran - Chief Accounting OfficerHuma Qamar - Chief Medical OfficerArun Upadhyay - Chief Scientific Officer and Head of Research & Development Conference Call Participants Michael Okunewitch - Senior Biotechnology AnalystRobert Leboyer - Senior Biotechnology AnalystSwayampakula Ramakanth - Managing Director & Seni ...

Ocugen (OCGN) Q1 2025 Earnings Call May 09, 2025 08:30 AM ET Company Participants Tiffany Hamilton - AVP & Head of Corporate CommunicationsShankar Musunuri - Co-Founder, CEO & ChairmanRamesh Ramachandran - Chief Accounting OfficerHuma Qamar - Chief Medical OfficerArun Upadhyay - Chief Scientific Officer and Head of Research & Development Conference Call Participants Michael Okunewitch - Senior Biotechnology AnalystRobert Leboyer - Senior Biotechnology AnalystSwayampakula Ramakanth - Managing Director & Seni ...

Ocugen (OCGN) Q1 2025 Earnings Call May 09, 2025 08:30 AM ET Speaker0 Good morning, and welcome to Ocugen's First Quarter twenty twenty five Financial Results and Business Update. Please note that this call is being recorded at this time. All participant lines are in listen only mode. Following the speakers' commentary, there will be a question and answer session. I will now turn the call over to Tiffany Hamilton, Ocugen's Head of Corporate Communications. You may begin. Speaker1 Thank you, operator, and go ...

Conference Call and Webcast Today at 8:30 a.m. ET OCU400 Phase 3 clinical trial for retinitis pigmentosa (RP) is progressing well and on target for potential BLA/MAA filings by mid-2026Anticipate initiating OCU410ST Phase 2/3 pivotal confirmatory clinical trial for Stargardt disease mid- 2025 MALVERN, Pa., May 09, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today reported first quarter 2025 financia ...

Core Insights - Ocugen, Inc. is set to present its innovative modifier gene therapy platform at two major conferences, highlighting its ongoing clinical trials for retinal diseases [1][2] - The company aims to file three Biologics License Applications (BLAs)/Marketing Authorization Applications (MAAs) within the next three years, addressing significant unmet medical needs [2] Conference Participation - Ocugen will participate in the ARVO 2025 Annual Meeting and Retina World Congress, showcasing its research and engaging with the retina community [1][2] - The company will present on its clinical trials for OCU400, OCU410ST, and OCU410, focusing on retinitis pigmentosa, Stargardt disease, and geographic atrophy respectively [1][5][6] Clinical Trials - OCU400 is currently in a Phase 3 clinical trial (LiMeliGhT) for retinitis pigmentosa, while OCU410ST is in a Phase 2/3 pivotal confirmatory trial for Stargardt disease [1][5] - OCU410 is undergoing a Phase 2 clinical trial (ArMaDa) for geographic atrophy secondary to dry age-related macular degeneration [1][6] Company Vision - Ocugen is committed to developing therapies for inherited retinal diseases and aims to provide access to these treatments globally [8][9] - The company emphasizes its gene-agnostic approach, which has the potential to treat multiple retinal diseases with a single product [2][9]