FDA agreement allows Vera Therapeutics to advance atacicept’s full approval timeline for IgA nephropathy by Q4 2026.
Vera Therapeutics (NASDAQ:VERA) secured U.S. FDA agreement on an accelerated timeline for its ORIGIN 3 eGFR analysis plan, supporting atacicept’s full approval for IgA nephropathy (IgAN). The company expects eGFR data in Q3 2026 and plans to file a supplemental Biologics License Application (sBLA) in Q4 2026.
The revised regulatory approach follows positive eGFR data from Vera’s ORIGIN Phase 2b trial. Atacicept targets BAFF and APRIL, positioning it as a potential first-in-class treatment for adult IgAN patients. CEO Marshall Fordyce highlighted the potential to expedite market approval.
Vera Therapeutics focuses on late-stage clinical development for immunological diseases, with atacicept as its lead candidate.