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

About this update from Vera Therapeutics, Inc.

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).1,2The TRUTAKNA dose is 150 mg injected subcutaneously once weekly, self-administered via an autoinjector by patients at home.1Investor webcast is scheduled for July 7 at 4:30 pm EDT.A Media Snippet accompanying this announcement is available by clicking on this link. 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 and we believe it has the potential to meaningfully transform the treatment landscape. We believe TRUTAKNA offers a novel approach to addressing this serious disease and has the potential to advance care for patients with this significant unmet medical need,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “We are grateful to the patients, investigators, study teams and regulators whose efforts made this achievement possible.” “I frequently hear from IgAN patients who are uncertain about what this disease may mean for their future, reflecting the historic high risk of poor outcomes with standard therapies,” said Richard Lafayette, M.D., F.A....

View stock analysis, news, and events for Vera Therapeutics, Inc.