Abivax Shares Surge as New Trial Data Eases Safety Concerns Over Ulcerative Colitis Drug

Shares of French biotech company Abivax surged on the Paris Stock Exchange on Tuesday after the company released positive clinical trial results for its inflammatory bowel disease treatment, a development that was also supported by analyst interpretations.

The strong rebound in sentiment came only a month after investors reacted sharply in the opposite direction, when earlier phase 3 trial disclosures raised concerns about safety signals, including reports of three cases of malignant tumors. That earlier update had triggered a steep sell-off, wiping around 30% off the biotech company’s market value.

By around 10:00 GMT (12:00 Paris time), Abivax shares had climbed dramatically on the SBF 120 index, reaching €113.10, a gain of 35.77%. The company is also listed on the Nasdaq in the United States, reflecting its dual-market investor base and international exposure.

Abivax rebounds as updated trial data restores confidence in its ulcerative colitis treatment and long-term safety profile

In response to the renewed interest and investor scrutiny, Abivax’s management scheduled a conference call for 8:30 PM GMT to present and clarify the latest trial findings. The company also reiterated its development roadmap, stating its intention to submit a Marketing Authorization Application (MAA) in the fourth quarter of 2026. The submission will focus on obefazimod, its lead candidate for the treatment of ulcerative colitis, a chronic and often debilitating inflammatory bowel disease that affects the colon.

According to the company’s press release, obefazimod demonstrated “significant clinical benefit” in patients participating in the study. A key highlight from the updated data was that increasing the dosage to 50 mg restored clinical remission in 45.5% of patients who had previously relapsed during an earlier stage of the trial. Abivax also emphasized that the results support the convenience of a once-daily oral treatment regimen, assessed over a 44-week global study period.

A major point of investor concern in the previous month had been the safety profile disclosed in early trial reporting, which included three cases of malignancies: prostate cancer, breast cancer, and a case of colonic dysplasia, a precancerous abnormality in tissue development. The mention of these events had unsettled markets significantly, despite Abivax’ position that the cases were not related to the treatment.

In the latest update, Abivax sought to provide additional context, stating that the expansion of its long-term safety database offers reassurance, with observed cancer and non-melanoma skin cancer rates aligning with expected levels in ulcerative colitis populations. Supporting this view, Professor Remo Panaccione of the University of Calgary’s Inflammatory Bowel Disease Clinic noted that the broader safety data continues to show consistency with anticipated incidence rates in such patients, reinforcing confidence in the evolving profile of obefazimod.

Overall, the latest results helped restore investor confidence, reversing recent losses and reinforcing optimism around Abivax’s lead candidate as it advances toward potential regulatory submission.

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(Featured image by Ruben Christen via Unsplash)

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First published in Le figaro. A third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

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