Obefazimod - (ABTECT)

July 30, 2026: Abivax SA (PARIS: FR, NASDAQ: ABVX) announced a positive pre-NDA interaction with the FDA for obefazimod (ABX464) in adults with moderately to severely active ulcerative colitis. The company said FDA feedback was constructive and resulted in alignment on its planned NDA submission strategy, including the planned content and format of the application.

Abivax said it remains on track to submit its first NDA for obefazimod by the end of 2026. The company also stated that this regulatory milestone follows positive Phase 3 ABTECT program results announced earlier in 2026, which it said support obefazimod in ulcerative colitis.

The catalyst is a pre-NDA regulatory update, with the next stated catalyst being the planned NDA submission by year-end 2026.