PARIS, France, July 30, 2026
Abivax SA announced the successful completion of a positive pre-New Drug Application (pre-NDA) interaction with the U.S. Food and Drug Administration (FDA) for obefazimod, its lead investigational therapy for adults with moderately to severely active ulcerative colitis (UC). During the meeting, the FDA provided constructive feedback that aligned with the company’s proposed NDA submission strategy, including agreement on the planned content and format of the regulatory filing. Based on the outcome of the interaction, Abivax remains on schedule to submit its first NDA for obefazimod by the end of 2026, marking a significant regulatory milestone for the clinical-stage biotechnology company. The progress follows the previously announced positive Phase 3 ABTECT program results, which continue to support obefazimod’s potential as a novel treatment option for patients living with chronic inflammatory bowel disease.
FDA Feedback Supports Regulatory Filing Strategy
The successful pre-NDA meeting represents a critical step in the U.S. regulatory process, allowing Abivax and the FDA to align on key aspects of the planned marketing application before formal submission. According to the company, the FDA’s feedback confirmed that the proposed NDA package, submission strategy, and planned documentation are consistent with regulatory expectations. Marc de Garidel, Chief Executive Officer of Abivax, described the outcome as an important milestone that strengthens confidence in the company’s regulatory pathway and reflects the agency’s constructive engagement throughout the development program. With regulatory alignment now established, Abivax will continue finalizing the application while maintaining its target of filing the NDA before the end of 2026.
Obefazimod Builds on Positive Phase 3 ABTECT Results
Obefazimod (ABX464) is Abivax’s lead investigational therapy designed to harness the body’s natural regulatory mechanisms to stabilize immune responses in patients with chronic inflammatory diseases. The therapy is currently being developed for moderately to severely active ulcerative colitis, a chronic inflammatory bowel disease that causes persistent inflammation and ulceration of the colon, leading to symptoms such as abdominal pain, diarrhea, rectal bleeding, and reduced quality of life. Earlier in 2026, Abivax reported positive Phase 3 ABTECT clinical trial results, providing the efficacy and safety data that now support preparation of the company’s first NDA. The encouraging Phase 3 findings position obefazimod as a potential new therapeutic option in the competitive ulcerative colitis treatment landscape, pending regulatory review and approval.
Advertisement
Company Advances Toward First Regulatory Submission
The positive FDA interaction marks another significant milestone in Abivax’s transformation from a clinical-stage biotechnology company toward potential commercialization. A successful NDA submission would represent the company’s first-ever marketing application and could pave the way for future regulatory filings in additional regions. As Abivax completes the remaining regulatory documentation, investors and clinicians will closely monitor the company’s progress toward its planned end-of-2026 NDA submission. If approved, obefazimod could expand treatment options for patients with moderately to severely active ulcerative colitis, while reinforcing Abivax’s strategy of developing therapies that target the underlying immune mechanisms responsible for chronic inflammatory diseases.
Source: Abivax,press release
