Abivax Stock Skyrockets On Strong Data From Inflammatory Bowel Disorder Study

Abivax SA (NASDAQ:ABVX) stock is skyrocketing on Wednesday after the clinical-stage biotechnology company announced overwhelmingly positive topline results from its Phase 3 ABTECT-1 (Study 105) and ABTECT-2 (Study 106) 8-week induction trials for oral obefazimod (ABX464) in adult patients with moderately to severely active ulcerative colitis.

The Paris-based company achieved a significant breakthrough with its experimental treatment, which demonstrated impressive efficacy and offers new promise to patients afflicted with this chronic inflammatory bowel ailment.

The ABTECT-1 and ABTECT-2 induction trials are assessing once-daily oral administration of obefazimod at 25 mg or 50 mg doses in adult patients with moderately to severely active ulcerative colitis. ABTECT-1 and ABTECT-2 were conducted simultaneously and have enrolled 1,275 patients.

Also Read: FDA Approves Expanded Use Of Eli Lilly’s Ulcerative Colitis Drug For Crohn’s Disease

Results from the ABTECT-1 and ABTECT-2 trials demonstrated that obefazimod met its FDA primary endpoint of clinical remission at Week 8 in the 50 mg once-daily dose regimens for both trials.

Individually, ABTECT-1 showed a placebo-adjusted clinical remission rate of 19.3% (p<0.0001) and ABTECT-2 demonstrated 13.4% (p=0.0001), each at the 50 mg once-daily dose, with all key secondary efficacy endpoints being met.

The 25 mg once-daily dose of obefazimod achieved the FDA primary endpoint of clinical remission at Week 8 in ABTECT-1, demonstrating a placebo-adjusted remission rate of 21.4%.

While the 25 mg dose did not achieve statistical significance for this endpoint in ABTECT-2, it achieved a pooled 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.

The safety profile of obefazimod remained consistent with prior clinical experience. No new safety signals were observed in either trial, and the treatment was generally well tolerated across both dose groups.

Ongoing ABTECT Phase 3 Maintenance Trial:

• 678 of 1,275 participants entered Part 1, the responder cohort.
• Topline maintenance results are expected in Q2 2026, which are intended to support regulatory filings globally.
• Contingent on positive 44-week maintenance results, Abivax intends to submit a New Drug Application to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency in the second half of 2026.

The company has postponed its first-half 2025 financial results announcement from August 11 to September 8, 2025. As of June 30, 2025, it had about $71.4 million (or 61.0 million euros) in cash and cash equivalents.

In March, Palatin Technologies Inc. (NYSE:PTN) shared topline results from its Phase 2 study of PL8177, a selective melanocortin-1 receptor (MC1R) agonist, in patients with active ulcerative colitis.

The company said clinical remission was achieved in 33% (3 of 9) of PL8177-treated patients versus 0% (0 of 3) on placebo.

Clinical response (statistically significant) was demonstrated in 78% (7 of 9) of PL8177-treated patients versus 33% (1 of 3) on placebo.

Price Action: ABVX stock is trading higher by 428.6% to $52.11 during the premarket session at last check Wednesday.

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