Vera Therapeutics FDA Approval TRUTAKNA

Vera Therapeutics received FDA accelerated approval for TRUTAKNA (atacicept-vymj) to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk for disease progression. TRUTAKNA is the first BAFF and APRIL inhibitor approved for IgAN, targeting upstream immunological drivers. The approval is based on a 42% reduction in proteinuria versus placebo at 36 weeks in the Phase 3 ORIGIN 3 trial. Confirmatory data on kidney function are expected in Q3 2026. Vera launched TRUTAKNA with a field force of 82 representatives, pricing at $425,000 per year. The company has $597 million in cash and access to additional $425 million. The IgAN market is estimated at $50 billion in 2026.