BRISBANE, Calif. — January 7, 2026 — Leads & Copy — Vera Therapeutics, Inc. (Nasdaq: VERA), a biotechnology company, announced that the FDA has accepted its Biologics License Application (BLA) for atacicept for Priority Review for treating adults with immunoglobulin A nephropathy (IgAN).
The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 7, 2026.
The BLA, submitted using the Accelerated Approval Program, could provide patients with an autoinjector for at-home self-administration of a once-weekly subcutaneous injection if approved.
According to Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics, atacicept offers a distinct approach through dual targeting of BAFF and APRIL. Fordyce added that the company believes it could advance the standard of care in IgAN, if approved. He also stated that the FDA’s Priority Review designation reinforces the need for new therapies to reshape the IgAN treatment landscape.
The BLA submission for atacicept is backed by data from an interim analysis of the ORIGIN 3 trial, which met the primary endpoint of proteinuria reduction at week 36. Participants treated with atacicept had a 46% reduction from baseline in proteinuria, measured by 24-hour urine protein-to-creatinine ratio (UPCR), with a statistically significant 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. The results were presented at the American Society of Nephrology Kidney Week meeting and published in the New England Journal of Medicine on November 6, 2025.
IgAN is a progressive autoimmune kidney disease that can lead to end-stage kidney disease or kidney failure in at least 50% of patients. Atacicept is being developed as a self-administered subcutaneous once-weekly injection that inhibits B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), cytokines that drive B-cell production of autoantibodies associated with IgAN and other autoimmune kidney diseases.
Atacicept has received FDA Breakthrough Therapy Designation for IgAN treatment, based on data from the ORIGIN Phase 2b clinical trial.
Atacicept is also being evaluated in expanded IgAN populations, anti-PLA2R positive primary membranous nephropathy, and anti-nephrin positive focal segmental glomerulosclerosis (FSGS) and minimal change disease (MCD) patients in the PIONEER trial.
Vera Therapeutics is focused on developing treatments for serious immunological diseases. Their lead product candidate, atacicept, is a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). Vera Therapeutics also holds an exclusive license agreement with Stanford University for VT-109, a novel, next generation fusion protein targeting BAFF and APRIL, and is developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus.
Investor Contact:
Joyce Allaire
LifeSci Advisors
212-915-2569
jallaire@lifesciadvisors.com
Media Contact:
Debra Charlesworth
Vera Therapeutics
415-854-8051
corporatecommunications@veratx.com
Source: Vera Therapeutics, Inc.
