BiotechTV - News SF Healthcare Week: Vera Therapeutics’ announced this week that the FDA accepted the company’s filing for atacicept, a potential new treatment for IgA Nephropathy
Jan 12, 2026
Marshall Fordyce, Founder and CEO of Vera Therapeutics, dives into the groundbreaking potential of atacicept for treating IgA nephropathy. He discusses the impressive FDA acceptance of their BLA filing and the important role of Phase III data published in NEJM. Fordyce explains how atacicept uniquely targets BAFF and APRIL to reduce immune complexes and improve treatment outcomes. As they prepare for a commercial launch, he highlights patient-friendly dosing options and clear communication with the FDA.
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Regulatory Momentum Into 2026
- Vera filed a BLA after publishing Phase 3 interim results and a New England Journal article.
- The FDA accepted the filing with priority review and a PDUFA date of July 7, 2026.
Two-Year Phase 2 Showed GFR Stabilization
- Vera ran a two-year Phase 2 trial showing GFR stabilization in young IgA nephropathy patients.
- That long-term data supported both their Phase 3 design and regulatory interactions.
Disease Burden And Regulatory Endpoints
- IgA nephropathy causes rapid kidney decline, often leading to dialysis before age 50.
- FDA requires long-term GFR as a confirmatory endpoint but may grant accelerated approval based on proteinuria reduction.