Abivax stock surges 30 percent on reassuring obefazimod safety data

• Abivax (NASDAQ:ABVX) shares climbed more than 30% after additional Phase 3 data showed cancer cases in the obefazimod ulcerative colitis trial were consistent with expected background rates.
• The supplemental data from the PALISADE maintenance study reinforced the drug’s safety profile, with no new concerns identified.
• Abivax remains on track to submit a new drug application for obefazimod in the fourth quarter of 2026.

Abivax stock climbed more than 30% after the French biotech released additional data from its late-stage trial of obefazimod, showing that cancer cases in the study were consistent with background rates expected in that patient population.

This release came about four weeks after Abivax stock fell as much as 40% following an earlier data readout that identified seven distinct cancer diagnoses.

The expanded cumulative safety data further strengthens confidence in the long-term safety profile of obefazimod.

Abivax said it remains on track to submit a new drug application to the U.S. Food and Drug Administration in the fourth quarter of 2026.

In the maintenance period, extended dosing at 50 mg produced clinical remission in 37.2% of patients, and dose escalation from 25 mg to 50 mg brought remission recovery in 45.5% of those who relapsed.

Analysts reacted positively, with Stifel, Oddo BHF, and Piper Sandler maintaining buy ratings and highlighting the reassuring safety profile.

Abivax is also testing obefazimod in Crohn’s disease, with results expected around mid-2027, amid speculation about a potential acquisition by a major pharmaceutical company.