Argenx SE (ARGX) has reported encouraging fourth-quarter and full-year 2025 results, marked by significant growth in global product net sales and continued expansion of the VYVGART franchise.
In a separate announcement, the company also released positive topline results from the Phase 3 ADAPT OCULUS trial in ocular myasthenia gravis (oMG), reinforcing its strategy to broaden the reach of its FcRn-based therapies.
For the fourth quarter of 2025, argenx generated $1.3 billion in global product net sales, up from $736.9 million in the same quarter of 2024.
Total operating income for the quarter increased to $1.32 billion compared with $761.2 million a year earlier.
For the full year of 2025, global product net sales reached $4.15 billion, nearly doubling from $2.19 billion in 2024.
Total operating income for 2025 was $4.25 billion, up from $2.25 billion in the prior year.
The company reported operating profit of $1.05 billion for 2025, marking its first profitable year, compared with an operating loss of $21.7 million in 2024. Full-year profit increased to $1.29 billion from $833.0 million a year earlier.
The company noted that more than 19,000 patients globally received VYVGART in 2025 across generalized myasthenia gravis (gMG), chronic inflammatory demyelinating polyneuropathy (CIDP) and for primary immune thrombocytopenia (ITP) in Japan.
The company has sought to expand the label of VYVGART to include the treatment of adults with acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia gravis, and the FDA decision date is due on May 10, 2026.
In a separate announcement, argenx reported that its Phase 3 ADAPT OCULUS trial of VYVGART met its primary endpoint in Ocular Myasthenia Gravis. The therapy was well tolerated, and no new safety concerns were identified. The results support a planned sBLA to the U.S. FDA for the treatment of ocular myasthenia gravis, a condition with no approved therapies.
Argenx continues to advance its "Vision 2030" strategy, which aims to treat 50,000 patients globally, secure 10 labelled indications across its approved medicines, and progress five pipeline candidates into Phase 3 development by the end of the decade. The company expects to have four Phase 3 molecules and 10 clinical-stage programs in development by the end of 2026, including next-generation FcRn candidates ARGX-213 and ARGX-124.
The company also anticipates multiple late-stage readouts in 2026 and 2027, including the ADVANCE-NEXT study in primary ITP, the ALKIVIA study in autoimmune inflammatory myopathies, and the UNITY study in Sjogren's disease. A registrational study in Graves' disease is expected to begin in 2026.
ARGX closed Wednesday's session at $816.95 down 2.78%. In premarket trading Thursday, the stock is down 0.39% at $814
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April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.