New York, June 1, 2026, 18:06 EDT
- Abivax’s American depositary shares on Nasdaq ended the day off 2.2% at $129.69. The stock was last seen around $86.01 in after-hours trade.
- Abivax said its oral ulcerative colitis drug obefazimod hit the primary endpoint in a 44-week Phase 3 maintenance study.
- Paris stocks ended the session ahead of the late data release. Euronext traders will get their first full chance to react on Tuesday.
Abivax shares tumbled in late U.S. trading on Monday, despite the French biotech putting out positive late-stage results for its main ulcerative colitis drug. The American depositary shares were at $86.01 after hours, a drop of 33.7% from their regular close at $129.69, according to Google Finance.
Abivax cleared a key clinical hurdle with the results, setting up for a planned U.S. submission. Phase 3 is the last big step in trials before regulators rule on drug approval, usually the final check before sales can begin.
Abivax reported its phase 3 ABTECT trial hit the main goal. Both the 25 mg and 50 mg once-daily doses of obefazimod cleared the primary endpoint of clinical remission by Week 44, meaning symptoms and visible signs dropped to a low level per trial rules.
Abivax’s Paris-listed shares ended Monday at €111.80, slipping 1.4%. The data dropped at 10:05 p.m. local time, after trading had shut on Euronext. The CAC 40 lost 0.45% at the close.
Abivax said 50.8% of patients on its 25 mg dose and 51.3% on 50 mg were in clinical remission at Week 44 in the maintenance study, compared to 10.4% for placebo. Both doses also met key secondary endpoints, such as endoscopic improvement, which looks at tissue appearance inside the body.
Safety remains a key watch point. Abivax reported no deaths and did not see any new safety signals. Treatment-emergent adverse events were logged in 58.0% of people on 25 mg, and 71.8% on 50 mg, versus 50.0% for the placebo group.
Abivax CEO Marc de Garidel said the results could “redefine the treatment landscape.” Chief Medical Officer Fabio Cataldi called it an “important milestone.” David T. Rubin at University of Chicago Medicine pointed to “meaningful efficacy and durable disease control.” Abivax
Abivax said it expects to file a New Drug Application with the U.S. Food and Drug Administration late in the fourth quarter of 2026. The NDA is the official request to get a new medicine cleared for sale by the FDA.
Abivax reported cash, cash equivalents and short-term investments of €491.6 million at the end of March, saying that would fund the company into the fourth quarter of 2027. First-quarter net loss came in at €48.5 million as R&D spend increased to €49.5 million.
Obefazimod, if cleared, heads into an ulcerative colitis space with plenty of competition. Oral drugs from AbbVie and Pfizer—Rinvoq and Velsipity—already have FDA approval for moderate-to-severe cases. Takeda’s Entyvio, which comes in IV and injectable forms, is another key player.
The big after-hours swing signals that just having a positive scientific readout isn’t enough after last year’s run. Investors still need to factor in the regulatory review, the label language, the higher rate of side effects at 50 mg, launch expenses, and the question of whether doctors will move patients over from competitors already on the market.
Abivax shares have been moving on takeover chatter. Back in March, Reuters said Abivax put out a denial over French media reports of possible AstraZeneca interest, after the CEO had already brushed off Eli Lilly bid rumors as just “noise.” Reuters
Abivax’s next big test comes on the business side. The company is aiming for an FDA filing in late 2026, half-year results are set for Sept. 21, and Crohn’s disease numbers are due in mid-2027. Now it’s up to traders to decide if Monday’s data back up the current stock price.
