Abivax shares surged 36% after trial data showed cancer cases in the obefazimod ulcerative colitis study fell within background reference ranges and affected patients already at risk. Piper Sandler’s upgrades and management’s plan to seek U.S. approval in Q4 alongside financing options drove the stock’s best gain in 11 months.
Abivax reported that cancer cases observed in its key obefazimod ulcerative colitis trial were within background reference ranges and occurred in patients already predisposed to tumors. This fresh safety data directly addressed investor concerns that the experimental drug could induce malignancies.
Following the release, shares climbed as much as 36%, marking the largest intraday rally since last July. Piper Sandler analysts highlighted the trial update’s potential to reinforce obefazimod’s safety profile and efficacy, prompting multiple upgrade recommendations.
Management confirmed plans to file for U.S. approval in the fourth quarter and to pursue European approval in the second quarter of next year. Filings in Japan and China are slated for 2027, underscoring the company’s global launch strategy.
CFO Didier Blondel is evaluating equity, debt and royalty financing to support commercialization efforts, while CEO Marc De Garidel has postponed seeking a European partner to avoid pricing conflicts linked to recent policy proposals.
