Argenx's efgartigimod meets primary endpoint in Phase 3 autoimmune myositis trial
ARGX•Argenx said its Phase 3 ALKIVIA trial met primary and key secondary endpoints in the combined autoimmune myositis population. IMNM patients improved significantly versus placebo, while dermatomyositis results did not reach statistical significance; a US filing for IMNM is planned by the end of 2026.
1. Trial results
Argenx reported that its Phase 3 ALKIVIA trial of efgartigimod met primary and key secondary endpoints in the combined autoimmune myositis population. Patients with immune-mediated necrotizing myopathy (IMNM) showed significant, sustained improvement versus placebo, while dermatomyositis patients showed clinically meaningful improvement that did not reach statistical significance in the smaller group.
2. Filing plans
Argenx plans a US filing for IMNM by the end of 2026, supported by FDA Breakthrough Therapy Designation. The results are scheduled for presentation at ACR Convergence on November 11, 2026, from 9:15 to 9:30 a.m. ET.
