Clinical Read2026-06-30

Obefazimod

AbivaxABVX

Indication
Moderately to Severely Active Ulcerative Colitis
Stage
Phase 3
Event
Phase 3 Data readout
Details

May 22, 2026 — Abivax SA reported Q1 2026 financial results and three-year interim data from Study 108, a Phase 2a/2b open-label extension evaluating long-term obefazimod in moderately to severely active ulcerative colitis after dose de-escalation from 50 mg to 25 mg once daily (eligibility: Mayo endoscopic subscore 0–1). Of 130 patients who entered the de-escalation study, 80% (104/130) remained enrolled and completed 144 weeks as of the Jan 5, 2026 cutoff. Intent-to-treat clinical remission rates (non-responder imputation) were 73% at week 48 (95/130), 69% at week 96 (90/130), and 68% at week 144 (88/130); 89% were in remission at baseline (116/130). Patients were treated for up to seven years overall with no new safety signals reported, supporting durability and tolerability of maintenance therapy.

Business update: topline results for the ABTECT Phase 3 UC maintenance trial are expected in late Q2 2026; potential NDA submission for UC is targeted for Q4 2026 (subject to positive data). Financially, Abivax reported €491.6M in cash/cash equivalents/short-term investments as of March 31, 2026, projecting runway into Q4 2027.

Financial Snapshot

Market Cap

$10.6B

Price

$129.69