Abivax (ABVX) shares surged 553% in recent Wednesday trading after the company said its investigational ulcerative colitis drug candidate obefazimod met the primary endpoint of clinical remission in two global phase 3 trials.
The 50 mg once-daily dose of obefazimod achieved statistically significant remission at week 8 in both the Abtect-1 and Abtect-2 studies, meeting the FDA-defined benchmark for clinical success, the company said.
In Abtect-1, obefazimod delivered a placebo-adjusted remission rate of 19.3%, while Abtect-2 showed a 13.4% benefit over placebo. The drug also met all key secondary endpoints, including clinical response and endoscopic improvement.
The company said the treatment was well tolerated in both dose groups, with no new safety signals observed.
Abivax said it is conducting a 44-week maintenance study with results expected in Q2 2026 and plans to apply for US and EU approvals in H2 2026 if the results are positive.
Price: 65.30, Change: +55.30, Percent Change: +553.00
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