Abivax Aligns with FDA on Obefazimod NDA for Ulcerative Colitis, Remains on Track for 2026 Filing
Abivax aligned with FDA on obefazimod NDA strategy for ulcerative colitis, targeting filing by end‑2026. Phase 3 ABTECT data at ECCO 2026 showed early symptom relief and positive DSMB safety review. Leadership appointments support potential commercialization.
Abivax announced the successful completion of a positive pre-New Drug Application (NDA) interaction with the U.S. Food and Drug Administration (FDA) for obefazimod in the treatment of moderately to severely active ulcerative colitis (UC). The constructive feedback resulted in alignment on the Company’s planned NDA submission strategy, and Abivax remains on track to submit its first NDA for obefazimod by the end of 2026. The progress builds on the positive Phase 3 ABTECT program results reported earlier this year.
In a separate update, the independent Data Safety Monitoring Board (DSMB) completed a safety review of the ongoing Phase 3 ABTECT-UC maintenance trial on March 18, 2026, and reported no new safety signals. Nearly 90% of enrolled participants have completed the 44-week treatment period. Topline results from the trial are expected in late Q2 2026.
At the 21st Annual Congress of the European Crohn’s and Colitis Organization (ECCO 2026), new data highlighted obefazimod’s potential in inflammatory bowel disease. A pooled safety analysis of the ABTECT-1 and ABTECT-2 trials showed comparable rates of serious adverse events and study discontinuations to placebo, with symptomatic relief beginning as early as week 1 and significant improvements by week 2. Preclinical and in vivo models demonstrated anti-fibrotic effects, suggesting possible applicability in Crohn’s disease. Biomarker analyses indicated increased expression of miR-124 and decreased inflammatory cytokines IL-17A and IL-6, supporting the mechanism of restoring immune balance.
To support potential commercialization and growth, Abivax strengthened its leadership team with the appointment of Michael Nesrallah as Chief Commercial Officer. Mr. Nesrallah brings more than 20 years of global biopharmaceutical leadership, including prior roles at Takeda where he led the U.S. inflammatory bowel disease franchise for Entyvio. The Company also appointed Keith Fournier, PhD, as Senior Vice President of Global Regulatory Affairs and Maurus de la Rosa, PhD, as Senior Vice President of Research.
Abivax reported its full year 2025 financial results, noting a strong financial foundation to execute on strategic priorities. The 2025 financial statements, approved by the Board on March 19, 2026, have been audited and filed with French and U.S. securities regulatory authorities.