Argenx Halts Phase 3 Study in Rare Disease Following Futility Analysis

Argenx SE (NASDAQ:ARGX) on Thursday delivered mixed clinical updates, announcing positive Phase 2 trial results for one experimental pipeline candidate alongside the failure of a Phase 3 study for another therapy. Phase 2 FB102 Celiac Disease Trial Success In its first clinical readout since acquiring Forte Biosciences in August 2026, the immunology company reported positive Phase 2 topline data for FB102 in adults with celiac disease. Celiac disease is a chronic autoimmune condition where eating gluten triggers an immune response that damages the lining of the small intestine, specifically destroying the tiny projections called villi that absorb nutrients. The first-in-class CD122 inhibitor met its primary endpoint, showing a statistically significant change in the villus height-to-crypt depth ratio at day 78 compared to placebo in patients undergoing a gluten challenge. Read Also: Argenx’s Next Blockbuster? Stock Jumps 12% After Phase 3 Myositis Trial Hits Key Goal The treatment also demonstrated consistent efficacy across secondary inflammatory, histologic, and clinical symptom measures. Argenx observed no new safety signals and plans to present detailed findings at an upcoming medical meeting. The drug also undergoes evaluation for vitiligo and alopecia areata. Phase 3 Sjögren’s Disease Study Discontinued Separately, Argenx announced it will discontinue its Phase 3 UNITY trial testing subcutaneous efgartigimod in moderate-to-severe Sjögren’s disease. Sjögren’s disease is a chronic autoimmune disorder where the immune system mistakenly attacks the glands that make moisture, like tear and saliva glands. An Independent Data Monitoring Committee recommended stopping the study for futility after an interim analysis indicated the trial could not meet its primary endpoint. Although the treatment showed safety consistent with its established profile, the company will analyze the data following study closure to guide prospective research. In May, the U.S. Food and Drug Administration (FDA) approved a label expansion for VYVGART (efgartigimod alfa-fcab) and VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for adult patients with generalized myasthenia gravis. ARGX Price Action: Argenx shares were down 15.34% at $786.00 during premarket trading on Thursday, according to Benzinga Pro data. Read Also: US Housing Affordability Nears Worst Level Since Financial Crisis as J.P. Morgan Says Market Is Effectively ‘Frozen’ Photo by Wirestock Creators via Shutterstock