Efgartigimod - (ALKIVIA)
- Indication
- Myositis subsets (Immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and dermatomyositis (DM))
- Stage
- phase3
- Event
- Conference Presentation
- Details
October 22, 2026: argenx SE (Euronext, Nasdaq: ARGX) reported Q3 2026 results and a pipeline update. VYVGART/VYVGART Hytrulo generated $1.7 billion in Q3 global net sales, up 54% year over year and 13% quarter over quarter. Regulatory milestones include an sBLA submitted to FDA for VYVGART in ocular myasthenia gravis; FDA priority review acceptance for VYVGART/VYVGART Hytrulo in pediatric gMG with a February 2027 PDUFA date; and positive Phase 3 ALKIVIA results showing consistent, clinically meaningful effects in IMNM and dermatomyositis, supporting a year-end 2026 sBLA for VYVGART Hytrulo in IMNM and an additional registrational study in DM. Primary ITP Phase 3 ADVANCE-NEXT topline is expected in 1H 2027; Phase 3 Graves’ disease VitaliThy studies are ongoing.
Empasiprubart (anti-C2): Phase 3 EMPASSION topline in MMN is expected in December 2026; Phase 3 EMVIGORATE and EMNERGIZE in CIDP are expected in 2H 2027; Phase 2 ADAPT-Forward in gMG is ongoing.
Other pipeline: FB102 will advance to Phase 3 in celiac disease after positive Phase 2 results; adimanebart Phase 3 in congenital myasthenic syndromes is expected to start in 2026, with Phase 2 in SMA ongoing; ARGX-121 Phase 2 in IgA nephropathy is ongoing; TSP-101, ARGX-118, and ARGX-125 are in Phase 1.
- Source
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