Catalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Tinlarebant (LBS-008) in Stargardt disease. The expected timing is based on the latest available company guidance and may change.
05/20/26:- NDA completion remains on track for Q2 2026; commercial leadership hiring completed. 06/12/26:- Rolling NDA submission completed. FDA 60-day filing review underway; acceptance decision expected by Aug 11, 2026 (est). 07/06/26:- Phase 3 DRAGON topline results to be presented July 8 and July 18, 2026. 07/20/26:- Ph3 DRAGON qAF secondary endpoint data presented at ASRS 2026. NDA filing decision expected Aug 11, 2026 (est). 08/11/26:- FDA accepted NDA; priority review granted. PDUFA action date set for February 12, 2027. 08/12/26:- DRAGON quantitative autofluorescence secondary endpoint data showed benefit at month 25. PDUFA decision is expected February 12, 2027.
Verification
Confirm timing and program details against the company announcement or filing.