Abivax says FDA pre-NDA feedback supports planned obefazimod filing by end-2026

Reuters2026/07/30 20:14

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Abivax received positive FDA feedback from pre-NDA discussions for obefazimod in moderately to severely active ulcerative colitis.
The FDA feedback backed Abivax’s planned NDA filing strategy, supporting the proposed content and format of the submission package.
The company reiterated it remains on track to file 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 via EQS News (Ref. ID: fr_reg_2374974_fr) 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 says FDA pre-NDA feedback supports planned obefazimod filing by end-2026

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