Ocugen Inc OCGN

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Ocugen is building an international pathway for OCU400 ahead of key Phase 3 data and a planned U.S. regulatory filing next year.

Ocugen will provide its investigational modifier gene therapy OCU400 through an expanded access program (EAP), with the goal of enabling the first patient to be treated for retinitis pigmentosa (RP) within 90 days, following full approval by the Longevity and Regenerative Therapies Board (LARTA Board)In partnership with the LARTA Board, Ocugen intends to address global access and unmet need through commercial pricing evidenced with cost-effectiveness for a one-time broad treatment of RPA novel m

The single global Phase 3 trial, ArMaDa3 (NCT07770828), is the first pivotal gene therapy trial in geographic atrophy (GA)U.S. Food and Drug Administration (FDA) granted OCU410 Regenerative Medicine Advanced Therapy (RMAT) designation, providing enhanced agency engagement throughout development and eligibility for accelerated approval and priority reviewPhase 3 design fully aligned with FDA; Biologics License Application (BLA) filing anticipated in 2028OCU410 is designed as a one-time subretinal

MALVERN, Pa., Aug. 25, 2026 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the Company will present on its innovative modifier gene therapy platform at upcoming investor and industry conferences in September 2026. Citi 2026 Biopharma Back to School ConferenceLocation: JW Marriott Essex House, New York City, NYDate: Wednesday, September 9, 2026Time: 3:40–4:15 p.m. ETFormat: F

Ocugen Inc (OCGN) advances its gene therapy pipeline with key regulatory milestones and strategic partnerships, despite a wider net loss and delayed BLA submission.

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 quarterGranted Regenerative Medicine Advanced Therapy (RMAT) designation by FDA for OCU410, enabling eligibility for priority review and accelerated approvalSigned a binding term sheet with Roots Pharmaceutical, and its strategic partner

MALVERN, Pa., July 31, 2026 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the Company will present on its innovative modifier gene therapy platform at upcoming investor conferences in August 2026. Oppenheimer 4th Annual Biotech in the Berkshires Summit Location: Miraval Resort, Lenox, MADate: Tuesday, August 4, 2026Time: 12:30–1:10 p.m. ETSession Title: Beyond the Readout:

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