Vera Therapeutics Receives FDA Accelerated Approval for TRUTAKNA™ for Adult Patients with Primary IgA Nephropathy

Vera Therapeutics Receives FDA Accelerated Approval for TRUTAKNA™ for Adult Patients with Primary IgA Nephropathy

TRUTAKNA is the first and only available therapy that binds both B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), addressing the immunological drivers at the source of IgA nephropathy (IgAN). 1,2 The TRUTAKNA dose is 150 mg injected subcutaneously once weekly, self-administered via an autoinjector by patients at home. 1 Investor webcast is scheduled for July 7 at 4:30 pm EDT.

BRISBANE, Calif., July 07, 2026 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted TRUTAKNA (atacicept-vymj) accelerated approval to reduce proteinuria in adults with primary IgAN at risk for disease progression. In a prespecified interim analysis of the ongoing ORIGIN 3 trial, participants treated with TRUTAKNA achieved a 46% reduction from baseline in proteinuria, with a statistically significant and clinically meaningful 42% reduction compared to placebo (p<0.0001) at 36 weeks. In this registrational program, TRUTAKNA was generally well tolerated. The most common adverse reactions were infections and local administration reactions. 1 IgAN is a serious, progressive, immune-mediated kidney disease and a leading cause of chronic kidney disease and kidney failure worldwide. 2,3 Approximately 160,000 patients are estimated to be impacted by IgAN in the U.S. Globally, approximately 2.5 adults per 100,000 are diagnosed with IgAN each year, most often between 30 and 40 years of age. 4,5 “The approval of TRUTAKNA as the first and only BAFF and APRIL inhibitor for IgAN marks an important milestone a...