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2 clusters · 2 sources · 7 days · First seen · Last updated

Abivax ulcerative colitis drug development

Overview

In late July 2026, Abivax SA announced the appointment of four senior commercial executives to lead marketing, patient services, sales, and market access ahead of a planned U.S. launch of its ulcerative colitis candidate, obefazimod. The hires were intended to ready the company for a New Drug Application filing with the FDA in the fourth quarter of 2026.

A week later, the company reported that the U.S. Food and Drug Administration provided positive feedback during a pre‑New Drug Application interaction. The agency’s comments were aligned with Abivax’s proposed submission strategy and timeline, reinforcing the company’s confidence that it will file the NDA for obefazimod by the end of 2026.

Entities

ulcerative colitis · Abivax SA · Marc de Garidel · obefazimod (ABX464) · U.S. Food and Drug Administration

Timeline

  1. 18 days ago

    [HEALTH] 2 sources
    Abivax Secures Positive FDA Pre‑NDA Feedback for Ulcerative Colitis Drug Obefazimod

    Abivax received positive FDA pre‑NDA feedback for its ulcerative colitis drug obefazimod and aims to file the first NDA by the end of 2026.

  2. 25 days ago

    [BUSINESS] 2 sources
    Abivax appoints new commercial leaders ahead of U.S. drug launch

    Abivax adds four senior commercial executives to prep its obefazimod drug for a U.S. FDA filing and potential launch.

Sources

backlinksseo.in · biotech-investments.com