Abivax says FDA pre-NDA feedback supports planned obefazimod filing by end-2026
ABVX•FDA pre-NDA feedback supports filing plan
Abivax said it 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.
