17 August 2026 | 7:36AM BST Equity Research Argenx SE (ARGX.BR): Myositis Phase 3 ALKIVIA readout a significant positive with DM representing upside As a reminder, as outlined at ARGX's July R&D event, in the ALKIVIA trial immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM) were assessed as separate populations allowing for filing in one or both of the subtypes based on the data generated. As such, the positive IMNM data allows for a regulatory filing where the drug was awarded FDA breakthr ...

This morning, Argenx announced positive topline results from the Phase III ALKIVIA trial of Vyvgart in Myositis, which met its primary endpoint on the overall population, delivering a 15.4-point improvement in mean TIS at Week 52 (47.95 vs 32.56; p=0.0011). More importantly, given Argenx plans to file these results by subtype, the IMNM subgroup saw a statistically significant benefit (p=0.0048) at a 14.8-point improvement (45.05 vs 30.24), whereas while the magnitude of the benefit was consistent across DM ...