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ARGX News
ARGX Events
Argenx Announces New Data from Phase 3 Study of Vyvgart Hytrulo
Argenx announced that new data from the Phase 3 study evaluating Vyvgart Hytrulo in patients with autoimmune myositis, focused on immune-mediated necrotizing myopathy, or IMNM, and dermatomyositis, or DM, will be featured as a late-breaking oral presentation during the American College of Rheumatology, or ACR, Convergence 2026 from November 6-11, 2026, in Orlando, Florida. The Phase 3 ALKIVIA study met its primary endpoint, achieving a 15.4-point greater improvement in mean Total Improvement Score, or TIS, versus placebo at Week 52 in the combined IMNM and DM population. Improvements in disease activity for the combined IMNM and DM population were observed as early as Week 4 and were sustained through the full 52 weeks of treatment, even with steroid tapering. A greater proportion of IMNM as well as DM patients achieved a mean total improvement score of 40 or more when treated with efgartigimod versus placebo. The median time to reach TIS greater than or equal to 40 was also shorter with efgartigimod for both subtypes and was sustained through the full 52 weeks of treatment. Efgartigimod was well-tolerated in the study. The observed safety profile of efgartigimod was consistent with prior studies and the known safety profile of efgartigimod.
Argenx Shares Drop 14.4% to $795.00
Argenx is down -14.4%, or -$133.44 to $795.00.
Immunovant Shares Down 6% to $30.05
Shares of Immunovant (IMVT), which has an ongoing Phase 2b Sjogren's disease study, are down 6% to $30.05 in morning trading.
Argenx Shares Down 12.4% to $813.25
Argenx is down -12.4%, or -$115.19 to $813.25.
Argenx Announces Phase 2 Study Results for FB102
Argenx announced topline results from the Phase 2 study evaluating FB102, a CD122 inhibitor, in adults with celiac disease. These results represent the first clinical readout of FB102 following Argenx's acquisition of Forte Biosciences in August. Patients treated with FB102 demonstrated a statistically significant and clinically relevant treatment effect compared to placebo. The study met its primary endpoint of change from baseline in the ratio of villus height-to-crypt depth at day 78 versus placebo in adults with celiac disease undergoing a gluten challenge. Broad efficacy measures, including intraepithelial lymphocyte, or IEL, density, villus height-to-crypt depth intraepithelial lymphocyte, or VCIEL, composite score, and symptoms, were consistent with the primary endpoint, providing additional evidence of effect across histologic, inflammatory, and clinical measures. The observed safety profile was consistent with prior studies and the known safety profile of FB102, with no new safety signals identified.
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