argenx Posts 63% Q1 Sales Rise to $1.3B, Sees PDUFA May 10
argenx generated $1.3 billion in first quarter product net sales, up 63% year-over-year, driven by VYVGART's 17th consecutive growth quarter. It is awaiting a May 10 PDUFA decision for seronegative gMG, expects myositis and ocular gMG readouts later this year, and advances ten pipeline candidates toward Phase 3 by 2030.
1. First Quarter Financial Results
argenx reported $1.3 billion in global product net sales for Q1 2026, marking a 63% increase year-over-year. Total operating income reached $1.313 billion, up from $807 million in Q1 2025, while research and development expenses totaled $443 million.
2. VYVGART Growth and Label Expansion
VYVGART sustained its 17th consecutive quarter of growth as argenx drives adoption in generalized myasthenia gravis and CIDP. A May 10 PDUFA target date is set for seronegative gMG, with ADAPT OCULUS topline data supporting a planned supplemental BLA for ocular MG.
3. Pipeline Progress and Upcoming Readouts
The company expects topline myositis (ALKIVIA) results in Q3 2026 and primary ITP (ADVANCE-NEXT) data in H1 2027. Empasiprubart’s MMN readout is due Q4 2026, alongside planned registrational studies in Graves’ disease and Sjogren’s by late 2027.
4. Strategic and Leadership Updates
Under its Vision 2030 strategy, argenx aims to treat 50,000 patients, secure ten labeled indications and advance five candidates to Phase 3 by 2030. In May, CEO Karen Massey joined the board and the company established a China affiliate to broaden research collaboration.