Vera Therapeutics' TRUTAKNA Meets All Endpoints in Final Phase 3 IgA Nephropathy Analysis

Vera Therapeutics Inc. (VERA) reported positive final efficacy results from the Phase 3 ORIGIN 3 trial of TRUTAKNA (atacicept-vymj) in adults with primary IgA nephropathy, with data presented at ASN Kidney Week 2026 and published in the New England Journal of Medicine. The company plans to submit a supplemental biologics license application to the FDA in the fourth quarter of 2026 to support full approval, which it expects could occur in 2027. TRUTAKNA, the first and only FDA-approved BAFF and APRIL inhibitor, met the primary endpoint of proteinuria reduction at 36 weeks and achieved statistical significance across all prespecified efficacy endpoints. The treatment improved estimated glomerular filtration rate, annualized eGFR slope and the risk of composite kidney disease progression events, with significant reductions in urine protein-to-creatinine ratio, galactose-deficient IgA1 and hematuria. The therapy was generally well tolerated, with adverse events in 75% of treated patients versus 78% on placebo, and serious adverse events in 7% versus 15%, respectively. No deaths occurred in the TRUTAKNA group, compared with one in the placebo group. VERA traded between $23.05 and $56.05 over the past year and was recently at $30.67, down 1.70%.