Vera Therapeutics Files for FDA Accelerated Approval of Atacicept in IgA Nephropathy

On November 7, 2025, Vera Therapeutics, a Nasdaq-listed biotechnology company based in Brisbane, California, announced that it had filed a Biologics License Application with the U.S. Food and Drug Administration for atacicept, a treatment for adults with immunoglobulin A nephropathy, known as IgAN. The filing goes through the FDA's Accelerated Approval Program. It is the company's first BLA.

The application rests on a prespecified interim analysis of ORIGIN 3, a Phase 3 trial. At week 36, participants on atacicept showed a 46% reduction from baseline in proteinuria, measured by the 24-hour urine protein-to-creatinine ratio. Compared with placebo, the reduction was 42%, which the company describes as statistically significant and clinically meaningful. That met the trial's primary endpoint.

The results were presented as a late-breaking oral presentation at the opening plenary session of the American Society of Nephrology Kidney Week meeting. They were also published in the New England Journal of Medicine on November 6, a day before the filing announcement.

ORIGIN 3 enrolled 431 adults with IgA nephropathy at sites around the world. It is randomized, double-blind and placebo-controlled. Participants were assigned 1:1 to receive either 150 mg of atacicept or placebo, injected subcutaneously once a week at home. The interim analysis looked at proteinuria, but the trial has not ended. It continues blinded to measure change in kidney function over two years, using eGFR, and is expected to finish in 2027.

IgAN is a serious, progressive autoimmune disease of the kidney. According to the company, at least half of patients can go on to end-stage kidney disease or kidney failure, with heavy consequences for their lives. Atacicept is an investigational fusion protein that blocks two cytokines, BAFF and APRIL. Both drive B cells to make the autoantibodies tied to IgAN, and potentially to other autoimmune kidney diseases. If approved, the company says, it would be the first B cell modulator to target both BAFF and APRIL in IgAN.

The drug has history behind it. An earlier Phase 2b trial, ORIGIN, met its primary and key secondary endpoints, with proteinuria reductions and stable eGFR versus placebo through 36 weeks. Through 96 weeks, Vera reports further improvement in Gd-IgA1, hematuria and proteinuria, and eGFR stability. Based on the Phase 2b data, the FDA granted atacicept Breakthrough Therapy Designation, which reflects its finding that the drug may offer substantial improvement over available therapies. The company says atacicept has been given to more than 1,500 patients across disease areas and that its safety profile appears favorable and comparable to placebo across the IgAN program.

Founder and CEO Marshall Fordyce called the filing an inflection point for the company and said atacicept could change the standard of care in IgAN and other autoimmune kidney diseases. He thanked patients, caregivers, health care professionals and the Vera team.

Vera is also studying atacicept further. The ORIGIN Extend study gives trial participants continued access until the drug might become commercially available in their region, and collects longer-term data. The PIONEER trial is testing it in expanded IgAN populations, anti-PLA2R positive primary membranous nephropathy, and anti-nephrin positive FSGS and minimal change disease.

The company anticipates potential FDA approval in 2026. That remains a hope, not a decision: the FDA has yet to act on the application, and the two-year kidney function data will not arrive until 2027.