Catalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Povetacicept in IgA Nephropathy (IgAN). The expected timing is based on the latest available company guidance and may change.
RAINIER trial. 10/25/24- Initiated trial. 5/5/25- Enrollment completed. Initiate IA once cohort reached 36wk of tx. File accelerated approval in H1 2026. 03/09/26:- RAINIER Week 36 interim positive. Complete IgAN BLA submission by end of March 2026. 06/01/26:- BLA accepted; PDUFA November 30, 2026. RAINIER Week 36 interim showed significant proteinuria reduction.
Verification
Confirm timing and program details against the company announcement or filing.