Abivax SA reports developments as a clinical-stage biotechnology company developing therapeutics that modulate immune response in chronic inflammatory diseases. Its news centers on obefazimod (ABX464), the company’s lead therapeutic candidate, including clinical and preclinical data in inflammatory bowel disease, Phase 3 ABTECT work in moderately to severely active ulcerative colitis, and related safety, efficacy, biomarker, and patient-reported outcome analyses.
Recurring updates also cover financial results, annual and regulatory reporting in France and the United States, American Depositary Share offerings, royalty certificate obligations, public-company governance, annual meeting materials, and trading references for its Euronext Paris and Nasdaq-listed securities.
Abivax (Nasdaq: ABVX) launched an underwritten public offering of approximately $600 million of American Depositary Shares in the United States, with an underwriters’ option for up to 15% additional ADSs.
Proceeds are intended for potential commercialization of obefazimod in the US, clinical R&D in ulcerative colitis and Crohn’s disease, and general corporate purposes. The offering will cause dilution and is subject to market conditions.
Abivax (Nasdaq:ABVX) reported topline Phase 3 ABTECT Maintenance Part 2 data for obefazimod in refractory ulcerative colitis. Among induction non-responders treated with 50 mg through Week 44, 37.2% achieved clinical remission and 34.5% endoscopic remission.
In patients relapsing during Maintenance Part 1, dose escalation or re-treatment with 50 mg recaptured clinical remission in about 45%. Across the integrated Phase 2/3 UC program (1,704 patient‑years), exposure‑adjusted malignancy and non‑melanoma skin cancer rates remained within published UC background ranges. Abivax plans a UC NDA submission in Q4 2026.
Abivax (Nasdaq:ABVX) reported topline Phase 3 ABTECT maintenance results for oral obefazimod in moderately to severely active ulcerative colitis.
At Week 44, clinical remission was 50.8% (25 mg) and 51.3% (50 mg) versus 10.4% placebo; all key secondary endpoints were met and safety was favorable. An NDA filing for UC is planned for Q4 2026, with Phase 2b Crohn’s induction topline data expected mid-2027.
Abivax (ABVX) reported Q1 2026 results and new three-year interim data from Phase 2a/2b open-label extension Study 108 of obefazimod in ulcerative colitis.
After dose de-escalation from 50 mg to 25 mg, 68% (88/130) remained in clinical remission at week 144, with no new safety signals and cash of €491.6M, giving a projected runway into Q4 2027. Key catalysts include ABTECT Phase 3 maintenance topline data in late Q2 2026 and a planned UC NDA submission in Q4 2026, subject to positive data.
Abivax (Nasdaq:ABVX) held its annual general meeting of shareholders on May 11, 2026, chaired by Board Chair Sylvie Grégoire.
Shareholders approved all resolutions proposed by the Board, including 2025 financial statements, executive and director compensation policy, and delegations for financial transactions. Detailed voting results will be posted on Abivax's website.
Abivax (NASDAQ:ABVX) announced repurchase of its Royalty Certificates for $90 million and the simultaneous pricing of a $45 million offering of 403,347 ADSs at $111.57 per ADS on May 5, 2026. The transaction pays $45 million cash at closing and converts the remaining $45 million into ADSs, cancelling the certificates.
The company reports cash, equivalents and short-term investments of €530.4 million as of December 31, 2025, and projects a cash runway into Q4 2027 unchanged after the repurchase.
Abivax (NASDAQ:ABVX) will present nine scientific abstracts on obefazimod at Digestive Disease Week, May 2–5, 2026, highlighting Phase 3 ABTECT efficacy, safety, patient-reported outcomes and preclinical anti-fibrotic models. Presentations include one oral session and multiple posters covering histologic, endoscopic, biomarker, and quality-of-life data.
Abivax (Euronext/Nasdaq: ABVX) will hold its Annual Ordinary and Extraordinary General Meeting on May 11, 2026 at 3:00 pm CEST in Paris (Paris Marriott Opera Ambassador).
Preparatory documents, agenda and draft resolutions are available to shareholders on the company website and were published in BALO on April 3, 2026 (N°2600756).
Abivax (Nasdaq: ABVX / Euronext: FR0012333284) filed its Universal Registration Document with the Autorité des Marchés Financiers and its Annual Report (Form 20-F) with the U.S. SEC. The 20-F filing date was March 23, 2026.
The Universal Registration Document contains the 2025 annual financial report, management and corporate governance reports, and statutory auditors' reports. Documents are available for download on Abivax, AMF, and SEC websites.
Abivax (NASDAQ:ABVX) reported full-year 2025 results and program updates on March 23, 2026. Key highlights include €530.4M cash and short-term investments (runway into Q4 2027), completion of a $700.3M net US offering, and a DSMB safety review reporting no new safety signals for the Phase 3 ABTECT-UC maintenance trial.
The Company remains on track to report topline ABTECT-UC maintenance results in late Q2 2026, appointed a new Chief Commercial Officer, and reported a 2025 net loss of €336.1M.