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On August 17, 2026, argenx SE announced positive topline results from the Phase 3 ALKIVIA trial of efgartigimod…
ARGXArgenx SE
On August 17, 2026, argenx SE announced positive topline results from the Phase 3 ALKIVIA trial of efgartigimod (VYVGART Hytrulo) for autoimmune myositis. The study met its primary endpoint in the combined immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM) population, showing a statistically significant 15.4-point greater improvement in mean Total Improvement Score at Week 52 versus placebo (p=0.0011). Efgartigimod also demonstrated a clinically meaningful benefit in the IMNM subtype with no approved therapy, achieving statistical significance (p=0.0048) and a 14.8-point improvement over placebo. The treatment effect was rapid, sustained through one year, and consistent across muscle and skin measures. argenx is a global immunology innovation company developing antibody-based medicines for severe autoimmune diseases.