OCGN

MALVERN, Pa., Sept. 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 OCU400 has been granted provisional approval and priority designation from the LARTA Board, the regulatory agency responsible for reviewing and approving longevity and regenerative therapy programs within the Commonwealth of The Bahamas. Ocugen will supply OCU400 through an EAP, with the goal of treating the first RP patient within 90 days, following full LARTA approval.

Ocugen NASDAQ: OCGN is preparing for three planned biologics license application, or BLA, submissions tied to late-stage gene therapy programs targeting retinal diseases, Chairman, Chief Executive Officer and Co-Founder Shankar Musunuri said during a company discussion.

Ocugen is advancing three gene therapy programs—OCU400, OCU410ST, and OCU410—targeting major unmet needs in ophthalmology. I assign OCGN a Buy rating, citing strong clinical data, upcoming pivotal trial catalysts, and sufficient cash runway, despite high commercial and execution risk. Key upcoming catalysts include Phase 3 data for OCU400 and OCU410ST (Stargardt) in 2027 and a Phase 3 trial for OCU410 now FDA-cleared.

MALVERN, Pa., Sept. 01, 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 first patient was dosed in the global Phase 3 registrational trial of OCU410 (AAV5-hRORA), its first-in-class modifier gene therapy candidate for GA secondary to dry age-related macular degeneration (dAMD). The Company also highlighted the recent FDA RMAT designation for OCU410, which supports a potential accelerated development and review pathway for the program.

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.

OCGN posts a wider Q2 loss as R&D spending climbs, while advancing late-stage gene therapy programs and extending its cash runway into 2028.

Ocugen NASDAQ: OCGN said its second quarter marked progress across its late-stage ophthalmology pipeline, including FDA clearance to begin a Phase III study of OCU410 in geographic atrophy and an RMAT designation for the program.

Ocugen, Inc. (OCGN) Q2 2026 Earnings Call Transcript

Ocugen (OCGN) came out with a quarterly loss of $0.07 per share versus the Zacks Consensus Estimate of a loss of $0.05. This compares to a loss of $0.05 per share a year ago.

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.