ARGX-213 - (FcRn)

July 31, 2025: argenx SE (Euronext & NASDAQ: ARGX) reported half-year 2025 results and a Q2 2025 business update, highlighting $949 million in Q2 2025 global product net sales for VYVGART/VYVGART SC (97% operational growth year-over-year; 19% vs Q1 2025). The company said the VYVGART SC launch in CIDP is progressing with >2,500 patients on treatment globally, and noted first patient dosed in Germany following European Commission approval for VYVGART-SC (vial and prefilled syringe) in CIDP. Decisions on prefilled syringe approval for gMG and CIDP are expected in Japan and Canada by end of 2025.

Pipeline catalysts/timelines:

• Efgartigimod: ADAPT-SERON (seronegative gMG) topline data expected 2H 2025; ADAPT OCULUS (ocular MG) topline expected 1H 2026; lupus nephritis proof-of-concept topline expected Q4 2025. Registrational readouts: ALKIVIA (myositis subsets) and UplighTED (TED) expected 2H 2026; UNITY (Sjögren’s) expected 2027; ADVANCE-NEXT (primary ITP) topline expected 2H 2026 to support an FDA submission for VYVGART IV.
• Empasiprubart: delayed graft function (DGF) topline expected 2H 2025; dermatomyositis (DM) topline expected 1H 2026; EMPASSION (MMN) topline expected 2H 2026; EMVIGORATE (CIDP) ongoing.
• ARGX-119: to start a registrational study in congenital myasthenic syndromes (CMS) in 2026 following positive Phase 1b proof-of-concept data; ALS Phase 2a topline expected 1H 2026; SMA proof-of-concept study planned to start by end of year; R&D webinar scheduled Sept 16, 2025.
• Early pipeline: Phase 1 results expected 2H 2025 for ARGX-109 (IL-6) and 1H 2026 for ARGX-213 (FcRn) and ARGX-121 (IgA); collaboration announced with Unnatural Products to expand into oral peptides.