Key facts
- Abivax shares surged 36% following the release of new clinical trial data for its ulcerative colitis drug, obefazimod.
- The Phase 3 ABTECT trial data showed significant improvements in clinical remission and bowel lining healing for patients.
- Safety data from Phase 2 and Phase 3 trials indicated cancer rates were within expected ranges for ulcerative colitis patients.
- Abivax plans to submit a New Drug Application for obefazimod to the US FDA in the fourth quarter of 2026.
- The company is also exploring obefazimod as a treatment for Crohn's disease.
Abivax shares experienced a significant surge of 36% on Tuesday, reaching €113.30 in Paris, following the release of positive clinical trial data for its experimental ulcerative colitis drug, obefazimod. The data from the maintenance phase of the Phase 3 ABTECT trial demonstrated that the oral treatment provided clinically meaningful improvements for adults with moderate to severe ulcerative colitis, including those who had not responded to previous treatments.
According to the company, after 44 weeks, 37.2% of patients who had not responded during the initial treatment phase achieved clinical remission, and 34.5% showed healing of the bowel lining. For patients whose disease returned after initial improvement, an increased dose of 50 mg helped 45.5% regain remission.
This positive update follows a previous setback where Abivax shares fell 44% in early June due to Phase 3 safety data. However, the company stated that an expanded safety analysis showed cancer rates remained within the expected range for individuals with ulcerative colitis. Across combined Phase 2 and Phase 3 data, representing 1,704 years of patient treatment, cancer rates (excluding non-melanoma skin cancer) were 0.35 and 0.64 cases per 100 patient-years for the combined treatment and 50 mg groups, respectively. Non-melanoma skin cancer rates were 0.59 and 0.64 cases per 100 patient-years.
Abivax Chief Executive Marc de Garidel expressed confidence in the long-term safety profile and favourable benefit-risk profile of obefazimod, reinforcing the company's readiness to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in the fourth quarter of 2026. The company is also investigating obefazimod for Crohn's disease, with mid-stage Phase 2 trial results anticipated in mid-2027, potentially expanding its market opportunity.