The stock price of Abivax SA (NASDAQ: ABVX) experienced a sharp increase, rising 560.40% to $66.04 after the company revealed extremely encouraging topline results from its Phase 3 induction trials. The effectiveness of obefazimod (ABX464), an oral, first-in-class miR-124 enhancer, in treating adult patients with moderately to severely active ulcerative colitis (UC) was assessed in these key studies, ABTECT-1 and ABTECT-2.
Topline Data Validates Efficacy and Safety
The outcomes of both induction trials mark a significant breakthrough for Abivax as well as the larger group of UC patients. With the 50 mg once-daily dosage, Obefazimod met the FDA’s main goal of clinical remission at Week 8, exhibiting statistically significant and clinically relevant results.
In particular, the placebo-adjusted clinical remission rate for ABTECT-1 was 19.3%, whereas the rate for ABTECT-2 was 13.4%. Additionally, every important secondary objective was accomplished. These results highlight the therapeutic potential of obefazimod and build upon and surpass the accomplishments of the previous Phase 2b study.
Global Trial Extent and Inclusion of Patients
The ABTECT-1 and ABTECT-2 studies were conducted concurrently and recruited 1,275 participants in 36 countries across more than 600 clinical trial sites. People with poor response, lack of response, or intolerance to both traditional and cutting-edge treatments, such as JAK inhibitors, were included in the patient group.
Due to its extensive breadth, the ABTECT study is the largest to include patients who are resistant to JAK inhibitors and is among the largest Phase 3 studies ever carried out for UC.
Path Toward Regulatory Approval
Pending the outcome of the ongoing 44-week maintenance study, Abivax plans to submit a New Drug Application (NDA) to the U.S. FDA in the second half of 2026. The favorable safety and tolerability profile of obefazimod further enhances its appeal as a potentially transformative treatment—both as a frontline option and for patients who have exhausted other therapies. Detailed results, including subgroup analyses, will be presented at an upcoming medical conference.
