VERA News & Events

Vera Therapeutics announced it has aligned with the U.S. Food and Drug Administration on a revised, earlier ORIGIN 3 eGFR analysis plan to support full approval for atacicept in adults with IgAN. "The eGFR results are now expected in the third quarter of 2026. Pending these results, Vera Therapeutics plans to submit an sBLA for full approval in the fourth quarter of 2026. Alignment with the FDA on a revised eGFR analysis plan follows a recent workshop hosted by the National Kidney Foundation which included clinicians, researchers, regulators, and patient advocates. In addition, the alignment with the FDA has been supported by the eGFR results from the ORIGIN Phase 2b trial of atacicept in IgAN," the company stated. "We are excited for the potential to deliver the first approved therapy targeting both BAFF and APRIL in adults with IgAN, and to bring forward the eGFR analysis to potentially support full approval of atacicept in this indication at an earlier date," said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics.

"The team at Vera Therapeutics is focused on execution as we advance atacicept toward potential FDA accelerated approval in IgAN," said Marshall Fordyce, Founder and CEO of Vera Therapeutics. "During the first quarter, we made meaningful progress across key pre-commercial activities, including in sales, marketing, market access, compliance, and commercial operations, to support a successful U.S. launch, pending regulatory approval. We are excited for atacicept to potentially be the first approved drug targeting both BAFF and APRIL in IgAN patients."