Abivax's Obefazimod Achieves Strong Efficacy in Phase 3 Ulcerative Colitis Maintenance Trial, NDA Planned
Summary
Abivax announced highly positive topline results from its Phase 3 ABTECT maintenance trial for obefazimod in moderately to severely active ulcerative colitis. Both 25 mg and 50 mg doses met the primary endpoint of clinical remission at Week 44, showing robust placebo-adjusted rates of 39.3% and 40.3% respectively, along with a favorable safety profile. This follows previous positive long-term data for obefazimod and significantly de-risks the lead drug candidate. The company plans to submit a New Drug Application (NDA) to the FDA in late Q4 2026, marking a critical step towards commercialization.
At the time of this announcement, ABVX was trading at $129.69 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $10.5B. The 52-week trading range was $5.69 to $148.83. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.