Empasiprubart - (VARVARA)

February 26, 2026: argenx (Euronext/Nasdaq: ARGX) reported full-year 2025 financial results and provided a Q4 business update, highlighting VYVGART franchise growth (Q4 2025 net sales $1.286B; FY2025 net sales $4.151B; total operating income FY2025 $4.248B) and $1.054B operating income in 2025 (first year of operating profitability).

VYVGART (efgartigimod; IV and SC): The company cited positive Phase 3 ADAPT OCULUS topline results for VYVGART SC pre-filled syringe in adult ocular myasthenia gravis (oMG), meeting the primary endpoint (Week 4 improvement vs placebo in MGII PRO ocular score; p=0.012) with no new safety concerns. These data support a planned sBLA to expand the label into oMG. For anti-AChR antibody–negative (“seronegative”) gMG (MuSK+, LRP4+ and triple seronegative), the FDA PDUFA target action date is May 10, 2026 (priority review referenced). Additional VYVGART timelines: primary ITP (ADVANCE-NEXT) topline in Q4 2026; ALKIVIA (autoimmune inflammatory myopathies/myositis) topline in Q3 2026; UNITY (Sjogren’s) topline in 2H 2027; Graves’ disease registrational study expected to start in 2026; SC autoinjector launch expected in 2027.

Empasiprubart (anti-C2): Phase 3 in MMN and CIDP; EMPASSION (MMN) topline expected Q4 2026; EMVIGORATE/EMNERGIZE (CIDP) topline expected 2H 2027; Phase 2 VARVARA (DGF) decision expected mid-2026 after 52-week efficacy analysis; ADAPT-Forward combination study ongoing (empasiprubart add-on to efgartigimod).

Adimanebart (MuSK agonist): Phase 3 registrational study in congenital myasthenic syndromes expected to start Q3 2026; Phase 2a ALS topline did not support continued development.

Earlier-stage programs: next-generation FcRn candidates in 2026 (ARGX-213 to enter patient studies; ARGX-124 to complete Phase 1); ARGX-121 Phase 2 in IgA nephropathy expected to start in 2026; ARGX-109 entering patient studies; three new Phase 1 entrants expected in 2026 (ARGX-118, ARGX-125, TSP-101).