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Abivax raises USD 600m to fuel US launch of obefazimod ahead of NDA submission

Abivax raises USD 600m to fuel US launch of obefazimod ahead of NDA submission

France-based Abivax SA (Euronext Paris: ABVX / Nasdaq: ABVX) announced the launch of an underwritten public offering of approximately USD 600 million of American Depositary Shares, with proceeds earmarked primarily for US commercialization preparations and continued clinical development of its lead asset obefazimod (ABX464). The scale of the raise reflects the company's positioning ahead of a potential NDA submission following positive Phase III maintenance trial data that supported the plans for an NDA submission.

The offering comprises ADSs, each representing one ordinary share, with Abivax granting underwriters a 15% overallotment option exercisable through the day of initial settlement. Leerink Partners, Morgan Stanley, Piper Sandler, and Guggenheim Securities are acting as joint bookrunning managers; LifeSci Capital is serving as bookrunning manager and Van Lanschot Kempen as lead manager.

Abivax intends to direct proceeds toward US pre-commercialization expenses for obefazimod, clinical research and development costs primarily for ulcerative colitis and Crohn's disease programs, and general corporate purposes.

This offering follows a USD 45 million ADS transaction in May 2026. As of March 31, 2026, Abivax held EUR 491.6 million in cash, cash equivalents, and short-term investments, with a projected runway into Q4 2027. The current USD 600 million raise would substantially extend that runway and fund the commercial infrastructure needed for a potential US launch.

Company overview and pipeline

Abivax is focused on development of drugs capable of modulating the immune response in patients with chronic inflammatory diseases. Its lead asset, obefazimod (ABX464), is an oral, once-daily small molecule that selectively modulates post-transcriptional regulation of inflammatory gene expression, reducing pro-inflammatory cytokine production. The compound is the subject of the Phase III ABTECT program evaluating its use in moderately to severely active ulcerative colitis.

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The ABTECT program comprises two induction trials, ABTECT-1 and ABTECT-2, which reported positive top-line results in July 2025, and a Phase III maintenance study (NCT05535946) whose positive results were reported in late Q2 2026. Separately, three-year interim data from Study 108, a Phase IIa/IIb open-label extension trial, demonstrated that 68% of patients who dose-de-escalated from 50 mg to 25 mg daily remained in clinical remission at week 144, with a positive safety profile. Abivax has stated its intention to submit an NDA for obefazimod in ulcerative colitis in Q4 2026, subject to positive maintenance data — a milestone it has now reached.

Beyond ulcerative colitis, Abivax is advancing obefazimod in Crohn's disease through the ENHANCE-CD Phase II study (NCT06456593), which is actively recruiting patients with moderately to severely active disease.


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