Catalyst overview
Research summary
This catalyst tracks a Phase 2/3 data readout for OCU410ST in Stargardt disease, Rare genetic disease. The expected timing is based on the latest available company guidance and may change.
GARDian trial. 10/22/24- DSMB approval of Ph2 initiation. 11/20/24- EMA granted orphan medicinal product designation. 2/27/25- FDA alignment to move forward with Ph2/3 pivotal confirmatory clinical trial. 5/27/25- Granted Rare Pediatric Disease Designation. 6/16/25- Received IND clearance. 7/18/25- Dosed first patient. 11/05/25:- GARDian3 50% enrolled; interim data mid-2026; targeting BLA filing in H1 2027. 03/04/26:- GARDian3 enrollment to complete Q1 2026; interim data Q3 2026; Ph2/3 topline Q2 2027; BLA filing 2027. 04/01/26:- GARDian3 dosing complete (N=63). Interim analysis Q3 2026; topline Q2 2027; BLA mid-2027. No serious AEs. 05/05/26:- Confirms GARDian3 enrollment/dosing complete (N=63); interim analysis Q3 2026; topline Q2 2027; BLA mid-2027. 08/06/26:- GARDian3 topline remains expected Q2 2027; BLA submission to follow mid-2027.
Verification
Confirm timing and program details against the company announcement or filing.