Why This French Biotech Stock Just Soared 586% in One Day
Abivax rockets higher on game-changing ulcerative colitis data and $400M cash infusion.
Shares of Abivax SA (NASDAQ: ABVX) went parabolic on Wednesday, skyrocketing 586% to close at $68.60 after the French biotech firm announced overwhelmingly positive Phase 3 data for its lead drug candidate, obefazimod, in treating moderate to severe ulcerative colitis (UC). The rally, one of the largest single-day percentage gains in biotech history, comes on the heels of dual pivotal trials showing statistically significant efficacy, excellent tolerability, and a clear regulatory pathway ahead.
Breakthrough in the Battle Against UC
Abivax reported topline results from its 8-week Phase 3 ABTECT-1 and ABTECT-2 induction studies, which evaluated daily oral doses of obefazimod—its first-in-class miR-124 enhancer. When pooled, the 50 mg dose demonstrated a placebo-adjusted clinical remission rate of 16.4% (p<0.0001), with ABTECT-1 showing 19.3% and ABTECT-2 posting 13.4%, both statistically significant. The treatment also met all key secondary endpoints and was generally well tolerated across both dose groups.
Marc de Garidel, CEO of Abivax, commented on the positive results, stating:
Today marks a significant milestone for Abivax, and more importantly, for the ulcerative colitis community. The strength of these results reinforces our belief in obefazimod, our first-in-class miR-124 enhancer, and its potential to become a transformative new treatment modality for patients with UC. Pending successful results from the 44-week maintenance trial, we are preparing to submit a New Drug Application to the FDA in the second half of 2026. We would like to thank the patients who participated in the trials, as well as the investigators and staff at over 600 sites in 36 countries who contributed to the landmark trials.
What sets the results apart is the robust response in patients who had failed previous advanced therapies, including the largest cohort of JAK inhibitor non-responders ever enrolled in a Phase 3 UC trial. Of the 1,275 patients randomized, 678 achieved clinical response and moved on to the ongoing 44-week maintenance trial, with top-line results expected in Q2 2026.
$400 Million War Chest
Just hours after revealing the trial data, Abivax announced a $400 million underwritten public offering to capitalize on investor enthusiasm and extend its financial runway. The deal includes American Depositary Shares (ADS) listed on the Nasdaq (NASDAQ: NDAQ), with a 30-day option for underwriters to purchase an additional 15% of the offering.
As of June 30, the company had approximately $71.4 million in cash. The fresh capital injection is expected to fund continued development of obefazimod, support pipeline expansion, and bolster commercialization efforts. The offering follows shareholder approval granted in June and will involve a capital increase without preferential subscription rights.
Dr. Fabio Cataldi, Chief Medical Officer of Abivax, emphasized the significance of the data and the company’s discipline, stating:
The exemplary results from the ABTECT induction trials reflect our dedication to scientific rigor and disciplined execution. We are thrilled to report outcomes that not only met but exceeded the bar set by our Phase 2b trial, a remarkable achievement that speaks volumes about the quality of our development program. We look forward to presenting more detailed analysis, including patients with inadequate response to prior JAK therapy at an upcoming medical conference.
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Wall Street Reacts
The street wasted no time recalibrating expectations. JMP Securities more than doubled its price target on Abivax, raising it from $33 to $95 and reaffirming a “Market Outperform” rating. Analysts cited the “highly compelling” nature of the data and the increasing probability of regulatory approval.
The market’s response was swift and emphatic. Trading in Abivax’s Euronext-listed shares was suspended ahead of the Nasdaq open to allow the ADSs to begin trading without disruption. By the closing bell, ABVX shares had more than sextupled.
What About Palatin?
Abivax’s breakout moment throws a spotlight on other UC drug developers, including Palatin Technologies (OTC: PTNT). In March, Palatin released early data from a Phase 2 study of its own UC treatment candidate, PL8177. The trial showed 33% of treated patients achieved clinical remission, but the study included only nine patients on the drug.
While Palatin’s data hinted at promise, it now faces stiff competition from Abivax’s large-scale, statistically powered program, which has blockbuster potential.
Looking Ahead
With obefazimod showing real clinical and commercial promise, Abivax has positioned itself as a serious contender in the multi-billion-dollar inflammatory bowel disease market. All eyes now turn to the ongoing maintenance trial and the company’s ability to execute on regulatory filings.
In the meantime, Wednesday’s explosion on Wall Street may have just marked the arrival of biotech’s next big winner.
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