Vera Therapeutics Aligns with FDA for Earlier Atacicept eGFR Analysis

Vera Therapeutics, Inc. announced alignment with the U.S. Food and Drug Administration (FDA) on a revised, earlier ORIGIN 3 eGFR analysis plan for atacicept in adults with IgA Nephropathy (IgAN). The eGFR results are now expected in Q3 2026, pulled forward from 2027. Pending positive results, the company plans to submit a supplemental Biologics License Application (sBLA) for full approval in Q4 2026, with potential full approval in 2027. The Prescription Drug User Fee Act (PDUFA) date for accelerated approval of atacicept is July 7, 2026.