Vera Therapeutics, Inc. (NASDAQ:VERA), a biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced it has aligned with the U.S. Food and Drug Administration (FDA) 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.
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