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Argenx's Celiac Drug Meets Primary Endpoint in Mid-stage Trial

MT Newswires·10/08/2026 01:36:24
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01:36 AM EDT, 10/08/2026 (MT Newswires) -- Argenx's (ARGX.BR) mid-stage study evaluating FB102 in adult celiac patients met its primary endpoint, the immunology company said Thursday. The mid-stage trial showed that FB102 delivered a statistically significant change from baseline in the ratio of villus height-to-crypt depth at day 78 compared with placebo in patients undergoing an eight-week gluten challenge. The drug candidate's broader efficacy measures, including intraepithelial lymphocyte density, villus height-to-crypt depth intraepithelial lymphocyte composite score, and symptoms, also remained in line with the primary endpoint. The safety profile was consistent with prior studies. Argenx, which secured FB102 through its recent acquisition of Forte Biosciences, plans to present detailed results of the phase 2 study at an upcoming medical meeting. It is also evaluating FB102 as a potential treatment in other autoimmune diseases, including vitiligo and alopecia areata.