Abivax’s $920M Wall Street Haul Follows Cancer Risk Resolution, Paving Way for US Launch

Abivax clears safety concerns in ulcerative colitis trial, secures record $920M US offering, sending shares to fresh highs and setting the stage for FDA filing in 2026.

Abivax has pulled off a double coup that few biotech stocks manage in the same week: it silenced safety doubts that had hung over its lead drug candidate and simultaneously locked down a record capital raise from US investors. The combination has sent shares surging and set the stage for a transatlantic commercial push.

Safety cloud lifts with integrated analysis

The French biotech released updated safety data from its expanded phase 3 programme for ulcerative colitis, covering more than 1,700 patient-years of exposure. An integrated analysis showed that the incidence of malignant tumours stood at 0.35 cases per 100 patient-years, rising to 0.64 in the higher-dose cohort. Both figures sit comfortably within the background rate of 0.30 to 0.70 observed in this patient population, easing the cancer scare that had rattled the stock in June when isolated malignancies were reported.

$920 million placed as banks exercise overallotment

Fresh off the positive safety readout, Abivax completed a blockbuster offering of American Depositary Shares (ADS) that grossed approximately $920 million – a significant step up from the initially targeted $800 million. Underwriters fully exercised their greenshoe option to meet the robust demand. The net proceeds are earmarked for the US commercial launch preparations and late-stage clinical work.

Chief among those priorities is obefazimod, the oral candidate for inflammatory bowel disease, which is now running pivotal studies for ulcerative colitis. The company is also advancing a separate programme in Crohn’s disease, with the newly raised capital covering research outlays for several years ahead.

Stock hits fresh high as trade resumes

Trading on Euronext Paris was briefly suspended on Friday to allow for orderly allocation of the new shares. When trading resumed, the stock shot up nearly 10% to close at €136.10, just shy of its all-time record of €139.10. During the session, it also carved out a new 52-week high of €134.10. Over the past twelve months, Abivax has gained more than 1,900%, making it one of the best-performing names in the European biotech space.

The Relative Strength Index now sits at 74, a level that historically warns of short-term overheating. But with the safety overhang cleared and a war chest of nearly a billion dollars, most analysts are focused on the longer-term catalyst flow.

FDA submission target set for late 2026

Abivax plans to file its Biologics License Application with the US Food and Drug Administration in the fourth quarter of 2026. If approved, obefazimod would become the first oral treatment of its drug class for ulcerative colitis. Investors are now awaiting top-line phase 3 data, which will ultimately determine the commercial viability of the molecule and the return on the company’s massive bet on the American market.