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argenx reports Phase 3 ALKIVIA study met primary endpoint with 15.4-point TIS improvement vs placebo
ARGXArgenx SE
The global Phase 3 ALKIVIA study evaluating VYVGART Hytrulo (efgartigimod) in patients with autoimmune myositis, specifically immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM), met its primary endpoint. The treatment achieved a statistically significant 15.4-point greater improvement in mean Total Improvement Score (TIS) versus placebo at Week 52 in the combined population (47.95 vs. 32.56; p=0.0011). Improvements were observed as early as Week 4 and sustained through 52 weeks, even with corticosteroid tapering. A greater proportion of patients achieved a TIS of 40 or more, indicating noticeable clinical benefit. The drug demonstrated a well-tolerated safety profile consistent with prior studies. These results will be presented as a late-breaking oral presentation at the American College of Rheumatology (ACR) Convergence 2026 on November 11. argenx is an immunology innovation company focused on developing treatments for underserved diseases through novel biology and antibody fragment technologies.