Abivax Reports Strong Ulcerative Colitis Data; All Eyes On Next Catalyst, Stock Up Over 400%

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(RTTNews) - Abivax SA (ABVX) has announced positive topline results from its phase III induction trials of its investigational drug Obefazimod in adult patients with moderately to severely active ulcerative colitis, sending its shares surging more than 400% in premarket trading.

The 8-week phase III trials, dubbed ABTECT-1 and ABTECT-2, were conducted simultaneously and have enrolled 1,275 adult patients with moderately to severely active ulcerative colitis. The studies evaluated once-daily oral administration of Obefazimod at doses of 25 mg or 50 mg.

The primary efficacy endpoint, i.e., the clinical remission as defined by the modified Mayo Score, per FDA requirements, is evaluated at week 8 for induction and at week 44 for maintenance.

According to the trial results announced today, 50 mg once-daily dose of Obefazimod demonstrated a placebo-adjusted remission rate of 19.3% in ABTECT-1 and a placebo-adjusted remission rate of 13.4% in ABTECT-2 at Week 8. On a pooled basis, the 50 mg dose led to a 16.4% placebo-adjusted clinical remission rate at Week 8 in the ABTECT-1 and ABTECT-2 trials.

Obefazimod at 25 mg dose also achieved the primary endpoint of clinical remission at Week 8 in ABTECT-1 trial, demonstrating a placebo-adjusted remission rate of 21.4%. While this dosage did not reach statistical significance for this endpoint in the ABTECT-2 trial, the pooled data showed a placebo-adjusted clinical response rate of 28.6%, indicating a strong signal for these patients to achieve clinical remission with extended treatment in the maintenance trial.

A phase III maintenance trial of Obefazimod in moderately to severely active ulcerative colitis, dubbed ABTECT Maintenance, is ongoing with the 44-week top-line results expected in Q2 2026.

When we alerted readers to ABVX on July 1, 2025, it was trading at $7.83.

In the last 1 year, the stock has traded in a range of $4.77 to $13.17. ABVX closed yesterday's trading at $10, down 1.38%. In premarket trading Wednesday, the stock is up over 400% at $51.