Generalized Pustular Psoriasis
VNDAVanda Pharmaceuticals Inc.Catalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Imsidolimab (IL-36 Inhibitor) in Generalized Pustular Psoriasis. The expected timing is based on the latest available company guidance and may change.
10/29/25:- Plans to submit a BLA for imsidolimab in generalized pustular psoriasis in Q4 2025. 02/11/26:- BLA for imsidolimab in GPP was submitted to FDA in Q4 2025; next review timelines not disclosed. 07/16/26:- EMA positive orphan opinion. FDA PDUFA set for December 12, 2026. 08/05/26:- BLA under review; PDUFA remains December 12, 2026.
Verification
Confirm timing and program details against the company announcement or filing.