Clinical Read2026-09-30

Efgartigimod - (ALKIVIA)

argenx SEARGX
Indication
Myositis subsets (Immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and dermatomyositis (DM))
Stage
phase3
Event
Topline Data
Details

July 23, 2026: argenx SE (Euronext/Nasdaq: ARGX) reported half-year 2026 results and provided a 2Q26 business update, highlighting $1.516B in 2Q26 global product net sales (up 60% YoY; up 17% QoQ), driven by the VYVGART franchise.

VYVGART / VYVGART Hytrulo (efgartigimod; FcRn blocker): The company said it launched an expanded U.S. label now covering all adult generalized myasthenia gravis (gMG) serotypes, including anti-AChR+, anti-MuSK+, anti-LRP4+, and triple seronegative. Upcoming/ongoing catalysts include plans to expand into ocular MG following positive ADAPT OCULUS results; registrational ALKIVIA (autoimmune myositis) topline in 3Q26; registrational ADVANCE-NEXT (primary ITP) topline in 1H27; registrational UNITY (Sjogren’s disease) topline in 2H27; and an ongoing registrational Graves’ disease study. An SC autoinjector is positioned to launch in 2027. Pipeline follow-ons: ARGX-213 is described as Phase 3 ready; ARGX-124 Phase 1 expected to complete by end-2026.

Empasiprubart (anti-C2): Registrational EMPASSION (MMN) topline expected 4Q26; registrational EMVIGORATE and EMNERGIZE (CIDP) topline expected 2H27; Phase 2 VARVARA (delayed graft function) showed a 52-week signal supporting further evaluation; ADAPT-Forward combo study in gMG ongoing.

Early pipeline: adimanebart Phase 2 in SMA ongoing; registrational CMS study expected to begin in 2026; ARGX-121 Phase 2 in IgA nephropathy expected to start in 2026; TSP-101 Phase 1 ongoing; ARGX-118 and ARGX-125 on track to enter Phase 1 in 2026.