Abivax SA (Nasdaq: ABVX) announced it has completed a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for obefazimod, its drug candidate for the treatment of adults with moderately to severely active ulcerative colitis.

According to a statement from the company, the FDA provided feedback that resulted in alignment on the planned NDA submission strategy, including the content and format of the submission. Abivax said it remains on track to file its first NDA for obefazimod by the end of 2026.

Marc de Garidel, Chief Executive Officer of Abivax, said: "Achieving alignment with the FDA on our NDA submission strategy marks an important milestone as we prepare to submit Abivax's first New Drug Application for obefazimod."

Abivax is a clinical-stage biotechnology company based in France and the United States. Obefazimod, also known as ABX464, is the company's lead drug candidate and has been in Phase 3 clinical trials for ulcerative colitis. The company previously announced results from its Phase 3 ABTECT program earlier in 2026.