Catalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for OCU400 in Retinitis Pigmentosa. The expected timing is based on the latest available company guidance and may change.
LiMeliGhT study. 4/8/24- Ph3 IND cleared. 4/10/24- Positive advice from EMA. 6/20/24- First patient dosed. 8/5/24- Approval for expanded access program (aged 18 & older). 8/26/24- Health Canada approval for Ph3 initiation. 1/13/25- Positive 2-yr data. BLA submission in H1 2026. 2/3/25- EC positive opinion. 11/05/25:- LiMeliGhT enrollment nearing completion; BLA rolling submission H1 2026; Ph3 top-line data Q4 2026. 03/02/26:- LiMeliGhT enrollment complete; rolling BLA on track Q3 2026; Ph3 topline data Q1 2027. 03/04/26:- liMeliGhT enrollment and Q1 2027 topline timing reiterated; rolling BLA submission remains planned for Q3 2026. 05/05/26:- PPQ complete Q2 2026; rolling BLA Q3 2026; topline Ph3 Q1 2027; potential approval Q4 2027. 08/06/26:- LiMeliGhT enrollment complete; topline data expected Q1 2027 before rolling BLA.
Verification
Confirm timing and program details against the company announcement or filing.