Efgartigimod - (ALKIVIA)

October 19, 2026: argenx SE (Euronext/NASDAQ: ARGX) reported Phase 3 ALKIVIA results for VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc; efgartigimod PH20 SC) in autoimmune myositis, focused on immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM), and said the data will be presented as a late-breaking oral at ACR Convergence 2026 on November 11, 2026.

In the Phase 3 study, efgartigimod met the primary endpoint in the combined IMNM and DM population, with a 15.4-point greater improvement versus placebo in mean Total Improvement Score at Week 52 (47.95 vs. 32.56; p=0.0011). Improvements were seen as early as Week 4 and were sustained through 52 weeks, including during protocol-mandated steroid tapering. A greater proportion of IMNM and DM patients achieved TIS ≥40 versus placebo, and median time to TIS ≥40 was shorter with efgartigimod for both subtypes. Safety was described as consistent with prior studies and the known safety profile.

ALKIVIA was a global randomized, double-blind, placebo-controlled, operationally seamless Phase 2/3 trial; 265 patients were randomized overall, and 175 patients received treatment in Phase 3.