Vera Advances eGFR Analysis to Q3 2026, Plans Q4 Supplemental BLA
VERA•Vera Therapeutics aligned with the FDA to accelerate its ORIGIN Phase 3 eGFR analysis from 2027 to Q3 2026 to support full approval of atacicept in IgA nephropathy patients. After the July 7, 2026 PDUFA date, Vera plans to submit a supplemental BLA in Q4 2026 pending positive eGFR results.
1. FDA Alignment and Accelerated Timeline
Vera Therapeutics has reached agreement with the U.S. FDA to move its ORIGIN Phase 3 eGFR analysis up to the third quarter of 2026 from the originally scheduled 2027 timeframe. This acceleration builds on positive interim data and aims to strengthen the case for full approval of atacicept in adult IgA nephropathy patients.
2. Regulatory Milestones and Submission Plans
The company’s Biologics License Application for accelerated approval carries a PDUFA date of July 7, 2026. Pending favorable Q3 eGFR results, Vera intends to file a supplemental BLA in Q4 2026 to pursue full approval by 2027.
3. Clinical Data and Pathway to Market
Atacicept demonstrated statistically significant proteinuria reductions and eGFR stabilization in ORIGIN Phase 2b and Phase 3 interim analyses with a safety profile comparable to placebo. With Breakthrough Therapy Designation secured, this FDA alignment highlights Vera’s potential to be first to market with a dual BAFF/APRIL therapy for IgA nephropathy.
