Vera Therapeutics and FDA Align on Earlier Atacicept Analysis for IgAN

Vera Therapeutics announced on June 2, 2026, that it has aligned with the U.S. Food and Drug Administration on a revised, earlier analysis plan for the ORIGIN 3 Phase 3 trial to support the potential full approval of atacicept in adults with IgA Nephropathy. The estimated glomerular filtration rate (eGFR) results from this analysis are now expected in the third quarter of 2026, having been pulled forward from an earlier timeline. Pending positive eGFR results, the company plans to submit a supplemental Biologics License Application (sBLA) for full approval in the fourth quarter of 2026.

This announcement builds on the company's ongoing regulatory and clinical progress. The FDA had previously set a Prescription Drug User Fee Act (PDUFA) date of July 7, 2026, for the Biologics License Application (BLA) seeking accelerated approval of atacicept. The earlier eGFR analysis is intended to support the path to full approval, which is expected in 2027.

Atacicept is a recombinant fusion protein that inhibits B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), cytokines that drive the production of autoantibodies associated with IgAN and other autoimmune kidney diseases. The company describes it as the first dual BAFF/APRIL-targeting therapy for adults with IgAN.

The June 2026 FDA alignment is supported by previous positive data from the ORIGIN program. The pivotal Phase 3 ORIGIN 3 trial met its primary endpoint, demonstrating that participants treated with atacicept achieved a 46% reduction from baseline in proteinuria as measured by 24-hour urine protein-to-creatinine ratio (UPCR). This represented a statistically significant and clinically meaningful 42% reduction compared to placebo (p<0.0001) at week 36. The safety profile of atacicept across the ORIGIN program appears favorable and comparable to placebo.

Vera Therapeutics submitted its initial BLA to the FDA in November 2025 through the Accelerated Approval Program for atacicept for the treatment of adults with IgAN. Atacicept had previously received FDA Breakthrough Therapy Designation for this indication.

The ORIGIN 3 trial (NCT04716231) is an ongoing global, multicenter, randomized, double-blind, placebo-controlled study of 431 adults with IgA Nephropathy. Participants were randomized 1:1 to atacicept 150 mg, self-administered at home via once-weekly subcutaneous injection, or placebo. The trial continues in a placebo-controlled blinded manner to evaluate changes in kidney function over two years as measured by eGFR and is expected to complete in 2027.