Abivax is a clinical-stage company developing obefazimod, a once-daily pill for ulcerative colitis that works through the microRNA miR-124; it is not yet approved.
Abivax's case rests on obefazimod, a once-daily pill for moderately to severely active ulcerative colitis. Both Phase 3 induction trials and the 44-week maintenance trial met their primary and key secondary endpoints, with placebo-adjusted remission of about 40% at week 44 for both doses. After a positive pre-NDA meeting, Abivax plans to submit its NDA at the end of 2026. A July offering raised €767.1 million net, which with June cash of €402.4 million funds plans into the fourth quarter of 2029.
Thesis checklist
1 risk needs attention
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: The NDA is submitted at the end of 2026
Does Abivax submit the NDA on time, and does FDA accept it for review?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
Select an event marker to read the update below. Marker colors show Thesis status.
Obefazimod passed Phase 3 in ulcerative colitis; Abivax plans to file at year-end
ABTECT Maintenance Part 2 topline results
Obefazimod met Phase 3 UC endpoints; integrated safety and the approvable dose now frame the regulatory path
ABTECT induction trials meet primary endpoint
About this history: every entry shows when the Thesis moved and what it said. The reasoning behind each move (the evidence, the analysis and the source filing) and the earnings write-ups are part of a subscription.
Dates, trials and completed outcomes are open to everyone. What each upcoming milestone hinges on is part of a subscription.
Disease areas: Liver and digestive diseases
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Competitive landscape
1 peers tracked
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.