Abivax S.A.

Abivax announced positive topline results from its Phase 3 ABTECT maintenance trial for obefazimod in ulcerative colitis. Both 25mg and 50mg doses met the primary endpoint of clinical remission at Week 44, showing significant placebo-adjusted rates. All key secondary endpoints were also met, and the drug demonstrated a favorable safety profile with no new signals. Abivax plans to submit an NDA to the FDA in late Q4 2026 and expects Crohn's disease trial results in mid-2027.

Abivax announced positive topline results from its Phase 3 ABTECT maintenance trial for obefazimod in moderately to severely active ulcerative colitis. Both the 25 mg and 50 mg once-daily doses met the primary endpoint of clinical remission at Week 44, demonstrating placebo-adjusted rates of ∆39.3% and ∆40.3% respectively. The trial also met all key secondary endpoints and showed a favorable safety profile with no new signals. The company plans to submit a New Drug Application to the FDA for obefazimod in ulcerative colitis in late Q4 2026, with Phase 2b Crohn's disease trial results expected mid-2027.

Abivax reported its Q1 2026 financial results and positive three-year interim data from Study 108, a Phase 2a/2b open-label extension trial of obefazimod in ulcerative colitis (UC). The study showed durable clinical remission in 68% of patients at week 144 following dose de-escalation, with no new safety signals observed over up to seven years of treatment. The company maintained a strong cash position of €491.6 million as of March 31, 2026, providing a cash runway into Q4 2027. Abivax anticipates topline results from its ABTECT Phase 3 maintenance trial in late Q2 2026 and plans for an NDA submission for obefazimod in UC in Q4 2026.

Abivax reported its first quarter 2026 financial results and positive three-year interim data from Study 108, a Phase 2a/2b open-label extension trial of obefazimod in ulcerative colitis (UC) patients. The study showed strong durable clinical remission, with 68% of patients maintaining remission at week 144 after dose de-escalation, and no new safety signals observed over up to seven years of treatment. The company ended Q1 2026 with €491.6 million in cash, cash equivalents, and short-term investments, providing a cash runway into Q4 2027, and anticipates Phase 3 UC trial results in late Q2 2026.

Abivax S.A. held its Annual General Meeting on May 11, 2026, where shareholders adopted all resolutions proposed by the Board. Key approvals included the financial statements for the 2025 fiscal year, the compensation policy for the Chairman, Chief Executive Officer, and directors, and delegations for financial transactions. Further details on the vote results will be published on the company's website.

Abivax SA repurchased all outstanding royalty certificates for a total of $90 million. The payment structure includes $45 million in cash and 403,347 American Depositary Shares (ADSs) issued in a private placement to the holders, valued at $45 million. This action aims to simplify the company's capital structure, reduce legacy obligations, and enhance financial flexibility, with the repurchased certificates immediately cancelled. The company's cash runway remains unchanged into Q4 2027.

Abivax announced the repurchase of all outstanding Royalty Certificates for $90 million, aiming to strengthen its balance sheet and simplify its capital structure. The repurchase will be partially funded by a $45 million cash payment and a $45 million offering of American Depositary Shares (ADSs) to the certificate holders. This transaction is expected to reduce the royalty overhang and maintain the company's cash runway into Q4 2027.

Abivax S.A. announced it will present nine scientific abstracts on its lead drug candidate, obefazimod, at the 2026 Digestive Disease Week from May 2-5. The presentations will highlight comprehensive efficacy, safety, and patient-reported outcomes from the Phase 3 ABTECT program for moderately to severely active ulcerative colitis. Additionally, preclinical anti-fibrotic activity will be showcased, reinforcing the company's confidence in obefazimod's potential to address patient and clinician needs.

Abivax S.A. announced that its Annual Ordinary and Extraordinary General Meeting will be held on May 11, 2026, at 3:00 pm CEST. The meeting will take place at the hotel Paris Marriott Opera Ambassador in Paris, France. Preparatory documents, including the agenda and draft resolutions, are available to shareholders on the company's website.