OCU400 — NDA/BLA submission
Q3 2026
We expect to begin a rolling BLA submission in the third quarter of 2026 and plan to complete the BLA submission by the second quarter of 2027.Source filing
OCGN biotech catalysts & pipeline
OCUGEN INC · Data as of 2026-09-08
Upcoming catalysts
OCU410 — FDA meeting
Q3 2026
We expect to meet with FDA/EMA to align on the Phase 3 study design and reach agreement by the third quarter of 2026.Source filing
OCU410ST — Interim data
Q3 2026
The interim outcome analysis of 24 subjects at 8 months post-OCU410ST (16 treated and 8 controls) is planned for the third quarter of 2026.Source filing
OCU400 — Topline data
Q1 2027
FDA feedback confirmed that the path to rolling BLA submission remains tied to topline data expected in the first quarter of 2027, and the company is advancing preparation accordingly, including successfully completing Process Performance Qualification (PPQ) batchesSource filing
OCU400 — NDA/BLA submission
Q2 2027
We expect to begin a rolling BLA submission in the third quarter of 2026 and plan to complete the BLA submission by the second quarter of 2027.Source filing
OCU410ST — Topline data
2Q 2027
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, respectivelySource filing
OCU410ST — NDA/BLA submission
mid-2027
Topline results anticipated in the second quarter of 2027, with a BLA submission to follow mid-2027Source filing
OCU400 — Regulatory decision
Q4 2027
We have successfully completed process performance qualification ("PPQ") batches in preparation for potential approval in the fourth quarter of 2027 as a treatment option for early- to late-stage RP.Source filing
OCU410 — Topline data
2028
2028 Topline data, BLA submissionSource filing
OCU410 — NDA/BLA submission
2028
Planned combined global Phase 3 trial of approximately 237 subjects powered at 95% for primary end point on track to initiate this quarter, with BLA and MAA filings targeted for 2028Source filing