Empasiprubart

February 27, 2025 — argenx SE reported full-year 2024 financial results and a fourth-quarter business update, highlighting strong growth of its VYVGART franchise (efgartigimod). Global product net sales (VYVGART IV and VYVGART SC) were $737.0 million in Q4 2024 and $2.186 billion for full-year 2024 (vs. $374.4 million Q4 2023 and $1.191 billion FY 2023). Total operating income was $2.252 billion in 2024, with an operating loss of $21.7 million; profit for 2024 was $833.0 million, driven by a deferred tax benefit of $802 million, including a one-time $725 million recognition of previously unrecognized deferred tax assets.

Business/regulatory updates: argenx received a positive CHMP recommendation for a VYVGART SC pre-filled syringe (PFS) for generalized myasthenia gravis (gMG), enabling EU launch; FDA review for PFS in gMG and CIDP remains on track with a PDUFA date of April 10, 2025. The company plans to run 10 Phase 3 and 10 Phase 2 studies in 2025 across efgartigimod, empasiprubart, and ARGX-119, supporting pipeline expansion and commercialization; it guided 2025 combined R&D and SG&A expenses of ~$2.5 billion.