Abivax Aligns with FDA on NDA Strategy For Obefazimod, Remains On Track For 2026 Submission

Abivax SA, a clinical-stage biotechnology company developing therapies for chronic inflammatory diseases, has successfully completed a positive pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) for obefazimod, its investigational treatment for adults with moderately to severely active ulcerative colitis (UC).

According to the company, the discussions with the FDA resulted in agreement on its planned NDA submission strategy, including alignment on the proposed content and format of the application. The constructive feedback from the agency provides greater clarity on the regulatory pathway and supports Abivax's plan to submit its first NDA for obefazimod by the end of 2026.

Marc de Garidel, Chief Executive Officer of Abivax, said reaching alignment with the FDA on the NDA submission strategy represents an important milestone for the company as it prepares its first regulatory filing for obefazimod. He added that the agency's feedback reinforces the company's confidence in its regulatory approach and helps advance preparations for the planned submission.

The company noted that this regulatory progress builds on the positive results from its Phase 3 ABTECT clinical program announced earlier this year. Those findings continue to support the potential of obefazimod as a treatment option for patients with moderately to severely active ulcerative colitis, a chronic inflammatory bowel disease with significant unmet medical needs.

Abivax remains focused on completing all remaining regulatory requirements and expects to submit the NDA for obefazimod to the FDA by the end of 2026, marking a key step toward the potential approval and commercialization of the therapy in the United States.