Abivax Shares Climb After Positive FDA Meeting on Ulcerative Colitis Drug

Shares of Abivax (ABVX) rose sharply on Thursday after the biotechnology firm announced a successful pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA). The positive outcome provides a clear regulatory pathway for obefazimod, its lead drug candidate for ulcerative colitis, removing a key uncertainty for investors.

FDA Aligns on Submission Strategy

Abivax disclosed that the FDA's feedback confirmed full alignment on the company’s planned NDA submission strategy for obefazimod, which is being developed to treat moderately to severely active ulcerative colitis in adults. The alignment covers the content and format of the regulatory dossier, a critical procedural step before a formal application can be filed.

In a statement, CEO Marc de Garidel called the development an "important milestone" that builds upon positive Phase 3 ABTECT program data released earlier in the year. The company reaffirmed its timeline to formally submit the NDA by the end of 2026.

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Market Reaction and Context

The market responded positively to the regulatory update, with Abivax stock climbing 3.7% to €112.5. The shares touched a session high of €113.7, well above the prior close of €108.5. This news provides a boost of confidence following a volatile period for the stock, which saw a significant sell-off in June over safety data concerns before recovering on updated trial results.

The gains were also supported by a constructive broader market environment, with major U.S. and European equity indices trading in positive territory. This backdrop created a favorable environment for risk assets, including development-stage biotechnology companies like Abivax.