Vera Therapeutics said the FDA granted accelerated approval to TRUTAKNA (atacicept-vymj) for adult patients with primary IgA nephropathy (IgAN) who are at risk for disease progression. The company reported a prespecified interim analysis from the ORIGIN 3 trial showing a 46% reduction in proteinuria from baseline, with a statistically significant 42% reduction versus placebo at 36 weeks. TRUTAKNA is the first therapy in a class designed to bind both BAFF and APRIL, targeting upstream immunological drivers of IgAN. Vera said the regimen is administered subcutaneously once weekly using an autoinjector by patients at home. Vera reported that TRUTAKNA was generally well tolerated, with infections and local injection reactions as the most common adverse events. The company positioned the approval as a potential shift in the treatment landscape for a disease with substantial unmet need and high risk of progression. Competition is already forming, with Vertex expected to make a regulatory decision in November for a BAFF/APRIL-blocking approach. The accelerated approval also places renewed emphasis on confirmatory evidence tied to proteinuria endpoints and longer-term progression measures.