Vera Therapeutics Submits Biologics License Application to U.S. FDA through Accelerated Approval Program for Atacicept for the Treatment of Adults with IgA Nephropathy

• Atacicept received FDA Breakthrough Therapy Designation for the treatment of IgAN
• ORIGIN Phase 3 trial met its primary endpoint at the prespecified interim analysis of proteinuria reduction with 46% reduction from baseline and 42% reduction vs placebo at week 36 (p<0.0001)
• If approved, atacicept would be the first B cell modulator targeting both BAFF and APRIL for IgAN; potential FDA approval in 2026
  

BRISBANE, Calif., Nov. 07, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) through the Accelerated Approval Program for atacicept for the treatment of adults with immunoglobulin A nephropathy (IgAN).

The BLA submission for atacicept is supported by data from a prespecified interim analysis of the ORIGIN 3 trial, which met the primary endpoint of reduction in proteinuria at week 36. Participants treated with atacicept achieved a 46% reduction from baseline in proteinuria as measured by 24-hour urine protein-to-creatinine ratio (UPCR), with a statistically significant and clinically meaningful 42% reduction in UPCR compared to placebo (p<0.0001) at week 36. The safety profile of atacicept across the ORIGIN program appears favorable, and comparable to placebo. Results of the interim analysis were presented as a late-breaking oral presentation at the opening plenary session of the American Society of Nephrology Kidney Week meeting and published in a manuscript in the New England Journal of Medicine on November 6.

“The submission of our first BLA marks an inflection point in our journey as a company, bringing us closer to delivering a breakthrough treatment that could change the standard of care for patients with IgAN and other autoimmune kidney diseases,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “Atacicept has the potential to address the unmet medical need in IgAN as the first dual BAFF/APRIL inhibitor. We look forward to working with the U.S. regulatory authorities to bring this treatment to patients. We are energized about the path forward and thankful to the patients, caregivers, HCPs, and the Vera Therapeutics team, whose contributions made this submission possible.”