(RTTNews) - Abivax SA (ABVX) has outlined a pivotal year ahead, pointing to updated market research and fresh safety analyses that underscore what the company believes a "significant opportunity" for its lead candidate, Obefazimod, in ulcerative colitis and Crohn's disease.
Ulcerative colitis (UC) remains a rapidly expandingglobal market with third-party analyses projecting sales to more than double from 2025 to 2032. The company noted that research suggests Obefazimod could emerge as a future market leader, particularly among the roughly 300,000 U.S. patients with moderate to severe disease who remain on conventional therapies due to reluctance toward advanced treatments.
ABTECT Phase 3 Program Moves Toward Key Readouts:
The company reported that the Data Safety Monitoring Board (DSMB) for its ABTECT Phase 3 maintenance trial found no new safety signals, with more than 80% of participants completing the 44-week double-blind maintenance period as of December 2025.
The ABTECT maintenance trial is a phase 3 study evaluating the long-term efficacy and safety of Obefazimod as a maintenance therapy in subjects with moderately to severely active ulcerative colitis.
Topline results from the maintenance study are expected in late Q2 2026, followed by a planned U.S. regulatory filing in late 2026. Abivax noted that ongoing NDA preparations include continued engagement with the FDA.
Crohn's Disease Program Progresses:
Beyond UC, Abivax is advancing the ENHANCE-CD Phase 2b induction trial evaluating Obefazimod in moderate-to-severely active Crohn's disease. Twelve-week induction results are anticipated in late 2026, helping inform the design of future registrational studies.
The company will also present 22 abstracts at the February 2026 European Crohn's and Colitis Organization (ECCO) meeting, including an oral presentation on Obefazimod's anti-fibrotic effects in preclinical models.
Pipeline Expansion and Combination Strategy:
Abivax plans to share initial preclinical data throughout 2026 from studies evaluating Obefazimod in combination with other mechanisms, including IL-23, a4b7, PDE-4 and AhR inhibitors. A lead combination candidate is expected to be selected by year-end.
The company is also assessing follow-on miR -124 enhancers and exploring in-licensing opportunities to broaden its inflammatory bowel disease (IBD) portfolio.
The company ended September 30, 2025, with cash, cash equivalents of EUR 589.7, with sufficient resources to fund into the fourth quarter of 2027.
ABVX has traded between $4.77 and $148.83 over the past year. The stock closed yesterday's trading at $126.48, up 6.20%.
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