TRUTAKNA (atacicept-vymj) - (ORIGIN 3)

July 7, 2026: Vera Therapeutics, Inc. (NASDAQ: VERA) announced the FDA granted accelerated approval to TRUTAKNA (atacicept-vymj) to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk for disease progression. Approval is based on a prespecified 36-week interim analysis from the ongoing Phase 3 ORIGIN 3 trial (NCT04716231), where TRUTAKNA 150 mg subcutaneous weekly (self-administered at home) produced a 46% reduction from baseline in UPCR and a 42% reduction vs placebo (p<0.0001) in the first 203 participants. A secondary endpoint showed a 68% reduction in galactose-deficient IgA1 (not multiplicity-adjusted).

Safety in ORIGIN 3 (n=428 treated or placebo) was generally well tolerated; common adverse reactions were infections (32% vs 28%) and local administration reactions (30% vs 5%). The company stated no serious/severe/opportunistic infections or hypogammaglobulinemia were observed in TRUTAKNA-treated patients.

Continued approval may depend on confirmatory evidence of clinical benefit: ORIGIN 3 remains placebo-controlled and blinded to assess eGFR change, with results anticipated in Q3 2026. An investor webcast is scheduled for July 7 at 4:30 pm EDT (also referenced as July 6 at 4:30 pm EDT).