VRTX PDUFA decision: Monday, November 30, 2026

…26; The U.S. FDA accepted the BLA submission for accelerated approval of povetacicept for adults with IgAN and assigned a PDUFA target action date of November 30, 2026. The submission is 5 supported by positive data from a pre-specified Week 36 interim analysis of the ongoing Phase 3 RAINIER trial

Dates are sourced from official registries and filings and can change — estimated dates (marked ~) slip routinely. This page updates automatically when the source registry moves the date. Research information only, not investment advice.