Atacicept - (ORIGIN 3)

June 2, 2026: Vera Therapeutics, Inc. (NASDAQ: VERA) said it aligned with the FDA on a revised, earlier ORIGIN 3 eGFR analysis plan intended to support full approval of atacicept for adults with IgA nephropathy (IgAN). The company stated the BLA for accelerated approval has a PDUFA date of July 7, 2026. The ORIGIN 3 eGFR analysis is now expected in Q3 2026 (moved up from 2027); if positive, Vera plans to submit a supplemental BLA (sBLA) for full approval in Q4 2026, with potential full approval in 2027.

Clinical background cited: ORIGIN Phase 2b met its primary and key secondary endpoints, showing statistically significant proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks, with comparable randomized-period safety to placebo. ORIGIN Phase 3 met its primary endpoint (proteinuria reduction at week 36) in a prespecified interim analysis and continues blinded to assess eGFR change, with results expected in 2026. Atacicept has FDA Breakthrough Therapy Designation for IgAN.