Argenx FB102 meets Phase 2 celiac endpoint

On Oct. 8, 2026, argenx reported that Phase 2 trial FB102-301 met its primary endpoint in 126 adults with celiac disease. After an eight-week controlled gluten challenge, two intravenous dose levels of FB102 improved the villus height-to-crypt depth (Vh:Cd) ratio—a biopsy measure of intestinal damage—at Day 78 versus placebo, with a p value of 0.0176. Argenx said the VCIEL composite score, intraepithelial lymphocyte density and symptoms were consistent with that result and reported no new safety signals. FB102 is an anti-CD122 antibody that blocks IL-2 and IL-15 signaling; argenx gained it in its $2.2 billion Forte Biosciences acquisition, completed Aug. 27. Chief medical officer Luc Truyen said that combined with the consistent safety profile observed across studies, these findings support advancing FB102 into Phase 3 development and further exploring its broader potential across immune-mediated diseases. No approved medicines currently exist for celiac disease. Separately that day, argenx disclosed discontinuation of the Phase 3 UNITY study of efgartigimod in Sjögren's disease. One account reported shares down 7.91% overnight to $854.98. Detailed Phase 2 data have not been released and are planned for a future medical meeting. Contested: none found. Rated coverage in the record was center only (0 left / 2 center / 0 right).