en.Wedoany.com Reported - French biotech company Abivax (Euronext Paris and Nasdaq: ABVX) saw its stock price experience sharp volatility after its ulcerative colitis (UC) candidate obefazimod yielded positive results in the Phase III ABTECT maintenance trial, but a safety signal raised investor concerns. Trial data showed that among the 580 enrolled patients, 9 developed malignant tumors, a situation deemed a safety issue by analysts at Jefferies, Morgan Stanley, Truist Securities, and Wedbush Securities.
On June 2, the first trading day after Abivax announced positive top-line results from the ABTECT maintenance trial (NCT05535946), the company's stock declined. The trial evaluated obefazimod for the treatment of adult patients with moderately to severely active UC. Jefferies analyst Faisal Khurshid noted in a report that the cancer signal complicates the picture; while the drug offers potent efficacy and oral convenience, the cancer cases observed during maintenance therapy could dampen investor interest and commercial adoption. Wedbush analyst David Nierengarten upgraded Abivax from "Underperform" to "Neutral" based on the overall data, but warned that the data could increase the risk of a black box warning on the drug's label upon approval. Morgan Stanley's Judah Frommer lowered the price target by 9% from $145 to $132, maintaining an "Overweight" rating; Truist Securities' Greg Renza cut the price target by 4% from $140 to $135, maintaining a "Buy" rating.
Among the 9 patients diagnosed with malignant tumors, 7 received obefazimod 50 mg, 1 received 25 mg, and 1 received placebo. Cases included squamous cell carcinoma, basal cell carcinoma, prostate cancer, breast cancer, and colonic dysplasia. Abivax stated that the prostate, breast, and colon cancer cases were assessed by investigators as unrelated to treatment, and some skin cancer cases were also deemed unrelated or unlikely to be related to the drug.
This information led investors to sell off shares on June 2, with Abivax's ordinary shares on Euronext Paris and American Depositary Shares (ADS) on Nasdaq both plunging 44%. However, a subsequent wave of analysts issued more positive commentary based on the overall positive results of the ABTECT study. Trial results showed absolute clinical remission rates of 50.8% and 51.3% for the 25 mg and 50 mg dose groups, respectively, far exceeding the 10.4% in the placebo group, with placebo-adjusted clinical remission rates of 39.3% and 40.3%. Obefazimod also met all key secondary endpoints, including endoscopic improvement and endoscopic remission. During an analyst conference call, Abivax CEO Marc de Garidel stated that obefazimod's endoscopic remission data (38% for the 50 mg group, 31% for the 25 mg group) surpassed several approved UC drugs, such as Eli Lilly's (NYSE: LLY) Omvoh and AbbVie's (NYSE: ABBV) Skyrizi (8%), as well as AbbVie's Rinvoq, Johnson & Johnson's (NYSE: JNJ) Tremfya, and Pfizer's (NYSE: PFE) Velsipity (20%).
Citizens JMP Securities analyst Jason Butler raised the company's price target by 43% to $187 based on the ABTECT data, maintaining an "Outperform" rating. He believes obefazimod's efficacy is best-in-class and its safety profile is compelling. Leerink Partners analyst Thomas J. Smith also noted that the results demonstrate best-in-class maintenance treatment characteristics. The positive analyst feedback influenced investors, and Abivax's stock subsequently rebounded approximately 40% on both exchanges. Abivax plans to submit a New Drug Application (NDA) for obefazimod to the FDA later in the fourth quarter.
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