Abivax Secures Positive FDA Pre‑NDA Feedback for Ulcerative Colitis Drug Obefazimod

Abivax SA, a clinical‑stage biotechnology company based in France and the United States, announced that the U.S. Food and Drug Administration gave positive feedback in a pre‑New Drug Application (pre‑NDA) interaction for its lead candidate obefazimod (ABX464). The agency’s constructive comments align with Abivax’s planned strategy and format for the upcoming NDA submission, which the company expects to file by the end of 2026 for the treatment of moderately to severely active ulcerative colitis.

CEO Marc de Garidel said the alignment marks a key milestone and reinforces confidence in the filing path, building on earlier positive Phase 3 ABTECT trial results. The announcement signals that Abivax remains on track to advance obefazimod toward regulatory approval.