Shares of Abivax (NASDAQ:ABVX) surged more than 400% in Paris trading on Wednesday after the French biotech company announced that its experimental drug obefazimod met key goals in two pivotal Phase 3 clinical trials for ulcerative colitis.
Topline results from the global ABTECT-1 (Study 105) and ABTECT-2 (Study 106) trials showed that a once-daily 50 mg dose of obefazimod achieved statistically significant clinical remission by Week 8, successfully meeting the primary endpoint in both studies.
The trials enrolled more than 1,200 adult patients with moderately to severely active ulcerative colitis who had failed or were intolerant to conventional or advanced therapies. Participants were treated with either 25 mg or 50 mg oral doses of obefazimod once daily.
In addition to the primary endpoints, all key secondary endpoints were also met with the 50 mg dose, further strengthening the drug’s potential as a treatment option.
On safety, Abivax reported that both doses were well tolerated with no new safety concerns identified during the trials.
“This is a significant milestone for Abivax,” the company said in a statement. The data pave the way for potential regulatory filings, contingent on long-term results.
Abivax plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in the second half of 2026, pending positive results from an ongoing 44-week maintenance study. Topline results from that trial are expected in the second quarter of 2026.
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