Abivax reports H1 2026 results, says NDA filing for obefazimod still on track for Q4
The company details pipeline progress, a completed royalty buy-back, and a cash runway it projects into Q4 2029 after its July offering.
Abivax SA reported financial and business updates for the six months ended June 30, 2026 in a filing dated September 21, 2026. On regulatory progress, the company said that following a positive pre-NDA interaction with the FDA, it aligned with the agency on the planned content, format and submission strategy for obefazimod's NDA for adults with moderately to severely active UC, and believes it remains on track to submit the NDA to the FDA in the fourth quarter of 2026.1
In Crohn's disease, the ENHANCE-CD Phase 2b trial of obefazimod is still ongoing, with the 12-week induction topline data readout expected in mid-2027.1 On combination therapy, additional preclinical data to support decision-making on a combination agent is expected by the end of 2026.1 The company also said it expects to announce the selection of a follow-on compound in 2026.1
Abivax disclosed three-year interim data from its Study 108 open-label extension trial. Of 130 patients enrolled, 80% (104/130) were still enrolled and completed the full 144-week evaluation as of a January 5, 2026 cutoff date; 89% (116/130) were in clinical remission at baseline, and 73%, 69% and 68% remained in remission at weeks 48, 96 and 144, respectively.1 The company said no new safety signals were observed, and it believes the data demonstrate durable clinical remission and a favorable long-term safety profile with up to seven years of obefazimod exposure.1
On financing, Abivax reported cash, cash equivalents and short-term investments of €402.4 million as of June 30, 2026, which, together with €767.1 million in net proceeds from the early July 2026 public offering, provides a projected cash runway into Q4 2029 based on current operating assumptions.1 Separately, on May 7, 2026 the company completed the repurchase and cancellation of all outstanding royalty certificates for total consideration of $90 million, comprising $45 million in cash and $45 million in equity through the issuance of 403,347 ordinary shares represented by ADSs.1
The company also announced Chief Medical Officer Fabio Cataldi will leave Abivax in the fourth quarter of 2026 and will be succeeded by Chris Rabbat, who has led Global Medical Affairs since 20231, and appointed Tim Kelly as Chief Technical Officer to lead the Company's commercial CMC, Quality and Information Technology functions.1
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