Abivax is a clinical-stage biotechnology company developing obefazimod, an oral, once-daily small molecule drug candidate for inflammatory bowel disease (IBD). Obefazimod works by enhancing miR-124, a micro-RNA that modulates multiple inflammatory pathways simultaneously — a mechanism Abivax argues is distinct from approved IBD therapies, which typically target a single cytokine or pathway. The primary target patients are those with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) who have not responded to conventional or existing advanced therapies. Abivax has no approved products and generates no product revenue. The company's Phase 3 UC induction trials (ABTECT-1 and ABTECT-2) reported top-line data in July 2025, showing a placebo-adjusted clinical remission rate of 16.4% at week 8 with statistically significant secondary endpoints. Phase 3 maintenance data are expected in late Q2 2026, and Abivax plans to submit an NDA to the FDA in Q4 2026 if those results are positive. Abivax is also running a Phase 2b trial in CD, with top-line data expected in Q4 2026. If obefazimod is approved, Abivax intends to commercialize it directly in key markets — selling primarily to gastroenterologists and specialty pharmacies — while licensing rights in select geographies for upfront payments, milestones, and royalties. Manufacturing is fully outsourced to contract manufacturers, keeping the capital model asset-light. Abivax funds operations through capital markets and has no manufacturing facilities of its own.
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