ARGX-119

October 30, 2025: argenx SE (Euronext & NASDAQ: ARGX) reported Q3 2025 global product net sales of $1.13B for VYVGART (efgartigimod; IV and SC), and provided multiple regulatory/clinical catalysts across its immunology pipeline.

VYVGART (efgartigimod): Approved in gMG and CIDP globally and primary ITP in Japan. Japan approved a VYVGART SC prefilled syringe for self-injection (Sept 2025); a Canada approval decision is expected by end of 2025. A supplemental BLA for VYVGART in AChR-Ab seronegative gMG subtypes (MuSK+, LRP4+, triple seronegative) is on track for FDA submission by year-end 2025. Registrational topline readouts expected: ADAPT-OCULUS (ocular MG) in 1H26; ADVANCE-NEXT (primary ITP) in 2H26; ALKIVIA (myositis subsets IMNM/ASyS/DM) in 2H26; UplighTED (thyroid eye disease) in 2H26. A registrational study in Graves’ disease is planned to start in 1H26. Phase 2 lupus nephritis data do not support advancing to registrational study.

Empasiprubart (anti-C2 mAb): Registrational EMPASSION (MMN) topline expected 2H26; registrational CIDP studies EMVIGORATE/EMNERGIZE ongoing; Phase 2 VARVARA (delayed graft function) topline expected around year-end 2025. Development in dermatomyositis stopped due to enrollment challenges.

ARGX-119 (MuSK agonist): Registrational CMS study to start in 2026; Phase 2a ALS topline expected 1H26; SMA proof-of-concept study to start by end of 2025.

Other: Expanded manufacturing partnership with FUJIFILM to add a North Carolina site. Next dated update: Feb 26, 2026 (full-year 2025 results/Q4 update).