Catalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Brepocitinib in Dermatomyositis . The expected timing is based on the latest available company guidance and may change.
VALOR: Enrollment complete, Ph3 Topline results in H2 2025. 9/17/25- Ph3 data announced; met primary endpoint. NDA filing in H1 2026. 03/03/26:- FDA accepted NDA; PDUFA action date Q3 2026; launch expected end-Sep 2026. 04/02/26:- Priority Review granted; PDUFA Q3 2026; launch expected September 2026.
Verification
Confirm timing and program details against the company announcement or filing.