Overview
- Abivax reported Monday that its Phase 3 ABTECT maintenance trial of oral obefazimod met its primary endpoint with about 50.8% remission at 25 mg and 51.3% at 50 mg versus 10.4% for placebo over 44 weeks.
- Both doses produced large placebo‑adjusted remission effects of roughly 39%–40%, outcomes analysts called among the strongest seen in late‑stage ulcerative colitis programs.
- Several malignancies — including prostate, breast and cases of colonic dysplasia — were reported in the 50 mg arm and investigators have so far judged those events unrelated to the drug.
- The safety reports triggered a sharp sell‑off, with U.S.‑listed Abivax shares falling more than 30% as investors and analysts weighed potential labeling or review hurdles.
- Abivax says it still plans an FDA New Drug Application in late Q4 2026, leaving near‑term regulatory review, possible label language and takeover interest as the key next milestones for patients and investors.