Core Insights - Ocugen (OCGN) is advancing its gene therapy programs for retinal diseases, with plans to file three regulatory applications in the next three years, resulting in a stock increase of 75.1% in 2025 compared to the industry's 20.9% rise [1] Group 1: OCU400 for Retinitis Pigmentosa (RP) - Enrollment is nearing completion in the phase III liMeliGhT study for OCU400, targeting retinitis pigmentosa, with top-line data expected in Q4 2026 [2][8] - Ocugen plans to file a biologics license application (BLA) for OCU400 in 2026, with a rolling submission starting in the first half of 2026 [2] - OCU400 has the potential to treat multiple gene mutations associated with RP with a single subretinal injection, unlike the only approved gene therapy that targets a specific mutation [3] Group 2: OCU410 for Stargardt Disease - The phase II/III GARDian3 study for OCU410ST, aimed at treating Stargardt disease, is ongoing, with interim data expected in mid-2026 and a BLA filing planned for the first half of 2027 [4][8] - There are currently no FDA-approved treatments for Stargardt disease, highlighting the potential market opportunity for OCU410ST [4] Group 3: OCU410 for Geographic Atrophy (GA) - OCU410 is in phase II development as a one-time gene therapy for geographic atrophy, with data expected in Q1 2026 and phase III starting in mid-2026 [5][8] - Currently, patients with GA have only one treatment option, which requires multiple injections and addresses only one aspect of the disease, while OCU410 aims to address multiple aspects [6]
Ocugen Stock Surges 75% Year to Date: What's in Store for 2026?