Vera Therapeutics, Inc.

Vera Therapeutics, Inc. is a late clinical-stage biotechnology company focused on developing and commercializing treatments for serious immunological diseases. The company's primary product candidate is atacicept, which is being developed for immunoglobulin A nephropathy (IgAN) and other autoimmune kidney diseases. Atacicept is a native human TACI-Fc fusion protein that binds to both B-cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL) cytokines, and it is designed for self-administration subcutaneously at home. Vera Therapeutics is conducting ORIGIN 3, a pivotal Phase 3 trial for atacicept 150 mg in IgAN. This trial met its primary efficacy endpoint, demonstrating a 46% reduction from baseline in proteinuria, measured by 24-hour urine protein-to-creatinine ratio (UPCR), at week 36. This represented a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo (p<0.0001). The incidence of adverse events was generally balanced between the atacicept and placebo groups, with fewer serious adverse events reported with atacicept (n=1 [0.5%]) than placebo (n=11 [5%]), no safety signals indicating immunosuppression, and no deaths in either treatment group. In November 2025, the company submitted a Biologics License Application (BLA) for atacicept for the treatment of adults with IgAN to the U.S. Food and Drug Administration (FDA) through the Accelerated Approval Program. On January 7, 2026, the FDA granted priority review to this application and set a Prescription Drug User Fee Act (PDUFA) target action date of July 7, 2026. The ORIGIN Phase 2b clinical trial, which evaluated atacicept in 116 participants with IgAN, reported positive results at 24 weeks in January 2023, 36 weeks in June 2023, and 96 weeks in October 2024. The ORIGIN 3 key secondary endpoint to support full approval is estimated glomerular filtration rate (eGFR) at 104 weeks, with results expected in 2027.