Abivax targets end-2026 FDA filing for obefazimod in Phase 3 ulcerative colitis program

Reuters2026/07/30 20:37

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Abivax completed a pre-NDA interaction with the FDA for obefazimod in moderately to severely active ulcerative colitis.
Phase 3 ABTECT program results were already presented earlier in 2026, supporting the planned regulatory filing.
FDA feedback aligned with the planned NDA submission strategy, supporting the planned content and format.
The company stayed on track to submit its first NDA for obefazimod by end-2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Abivax SA published the original content used to generate this news brief on July 30, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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Abivax targets end-2026 FDA filing for obefazimod in Phase 3 ulcerative colitis program

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