argenx to present Phase 3 ALKIVIA myositis data at ACR Convergence 2026

argenx SE said on October 19, 2026 that new data from the Phase 3 ALKIVIA study of VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) will be presented as a late-breaking oral session at the American College of Rheumatology Convergence 2026, held November 6-11 in Orlando, Florida. The company describes ALKIVIA as the first registrational study of an FcRn blocker in autoimmune myositis, focused on immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM).¹

The study reached its primary endpoint. In the combined IMNM and DM population, efgartigimod produced a 15.4-point greater improvement in mean Total Improvement Score (TIS) than placebo at Week 52, with scores of 47.95 versus 32.56 and a p-value of 0.0011.¹ Benefits in that combined population appeared as early as Week 4 and persisted through the full 52-week treatment period, including during a required steroid taper.¹ A larger share of patients in both IMNM and DM subtypes reached a TIS of 40 or higher on efgartigimod than on placebo, and they reached that threshold faster, with the effect holding through 52 weeks.¹ The company said efgartigimod was well tolerated, with a safety profile consistent with earlier studies.¹

ALKIVIA was a global, randomized, double-blind, placebo-controlled, operationally seamless Phase 2/3 trial that enrolled 265 patients on background treatment, randomized 1:1 to weekly efgartigimod PH20 SC or matched placebo; 175 patients were treated in the Phase 3 portion, which included a mandated corticosteroid taper, with TIS at Week 52 as the primary endpoint.¹

The trial ran across North America, Europe, and Asia-Pacific including China and Japan, with Zai Lab recruiting Chinese patients under its exclusive license with argenx for VYVGART and VYVGART Hytrulo in Greater China.¹ The lead author for the presentation is Dr. Rohit Aggarwal, with the session scheduled for 9:15-9:30 a.m. ET on November 11.