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