Abivax S.A. ABVX
Abivax S.A. (Nasdaq: ABVX) is a GI/hepatology drug developer. Its lead program, obefazimod, is in Phase 3 for moderately to severely active ulcerative colitis. Its next catalyst on record is miR-124 platform: selection of follow-on compound (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: miR-124 platform — selection of follow-on compound (2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| obefazimod | ulcerative colitis (ABTECT induction + maintenance) | small molecule | Phase 3 |
| obefazimod | Crohn's disease (ENHANCE-CD) | small molecule | Phase 2 |
| obefazimod + etrasimod combination | inflammatory bowel disease | small molecule | Pre-clinical |
| miR-124 follow-on compound | IBD | small molecule | Pre-clinical |
Recent results and decisions
- Sep 21, 2026n/a Abivax expects to submit NDA to the U.S. FDA for obefazimod in moderately to severely active ulcerative colitis in the fourth quarter of 2026.
We believe we remain on track to submit our NDA to the U.S. FDA in the fourth quarter of 2026.
Filing - Jun 29, 2026positive ABTECT Maintenance Part 2 (exploratory): 37.2% of induction non-responders on 50 mg reached clinical remission at week 44 and 45.5% of relapsers escalated 25 to 50 mg recaptured remission; malignancy EAIRs within UC background.
Obefazimod delivered meaningful clinical benefit in a highly refractory ulcerative colitis (“UC”) population, with 37.2% of induction non-responders achieving clinical remission and 34.5% achieving endoscopic remission at Week 44 following continued 50 mg treatment
Filing - Jun 1, 2026met Phase 3 ABTECT maintenance met primary endpoint at week 44: clinical remission 50.8% (25 mg) and 51.3% (50 mg) vs 10.4% placebo, placebo-adjusted 39.3% and 40.3%, p<0.0001; all key secondaries met, no new safety signals.
At Week 44, both the 25 mg and 50 mg once-daily obefazimod doses met the primary endpoint, demonstrating placebo-adjusted clinical remission rates of ∆39.3% and ∆40.3%, respectively (25 mg: 50.8%, 50 mg: 51.3% vs placebo 10.4%; p<0.0001)
Filing
3 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 GI/hepatology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.