Argenx's Efgartigimod Meets Primary Endpoint in Phase 3 Autoimmune Myositis Trial

• argenx’s Phase 3 ALKIVIA trial met primary and key secondary endpoints for efgartigimod in combined immune-mediated necrotizing myopathy (IMNM) and dermatomyositis populations.
• IMNM patients showed statistically significant, clinically meaningful improvement; the disease has no approved treatments.
• Dermatomyositis patients experienced clinically meaningful benefits, but results did not reach statistical significance in the smaller cohort.
• An FDA supplemental biologics license application for IMNM is planned by year-end 2026, supported by Breakthrough Therapy Designation.
• Results will be presented at American College of Rheumatology Convergence on November 11, 2026.

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