Atacicept - (PIONEER)

May 7, 2026: Vera Therapeutics, Inc. (NASDAQ: VERA) reported Q1 2026 business highlights and financial results and said the FDA granted Priority Review to its BLA seeking accelerated approval of atacicept for adult IgA nephropathy (IgAN), with a PDUFA target action date of July 7, 2026. The company said it remains on track for a potential U.S. commercial launch in mid-2026, pending approval.

Upcoming catalysts: (1) potential FDA accelerated approval decision for atacicept in IgAN (PDUFA July 7, 2026); (2) initial results from PIONEER, a Phase 2 basket trial of atacicept in expanded IgAN populations and other autoimmune kidney diseases, expected in Q2 2026; (3) pivotal two-year eGFR data from the ongoing ORIGIN Phase 3 trial (“ORIGIN 3”) expected in Q1 2027.

Clinical context provided: ORIGIN Phase 2b met primary and key secondary endpoints with proteinuria reductions and eGFR stabilization vs placebo through 36 weeks; ORIGIN Phase 3 met its week-36 proteinuria primary endpoint in a prespecified interim analysis and continues blinded for two-year eGFR outcomes.

Financials: Q1 2026 net loss was $121.0M ($1.69/share); cash/cash equivalents/marketable securities were $596.8M as of March 31, 2026.