Amsterdam, Netherlands- and Boston-based argenx SE (NASDAQ:ARGX), a global immunology company, reported preliminary full-year 2025 global product net sales of $4.15 billion, reflecting strong commercial momentum for its flagship FcRn antagonist VYVGART (efgartigimod) and its subcutaneous formulation VYVGART Hytrulo.
The company estimates that approximately 19,000 patients are currently receiving VYVGART treatment worldwide across approved indications, including generalized myasthenia gravis (gMG), chronic inflammatory demyelinating polyneuropathy (CIDP), and other autoimmune disorders.
Elsewhere, Argenx anticipates several key clinical and regulatory milestones in 2026.
The company expects the first registrational readout for empasiprubart (ARGX-117), its C2 inhibitor, along with topline results from the Phase 3 ocular myasthenia gravis study in the first quarter of 2026.
Additional registrational data are anticipated throughout the year across multiple indications.
By the end of 2026, argenx aims to have 10 molecules in clinical development, including advancement of next-generation FcRn franchise candidates ARGX-213 and ARGX-124.
A supplemental biologics license application (sBLA) for VYVGART in seronegative gMG could support a potential label expansion and commercial launch by year-end 2026, if approved.
The company also noted that proposed management succession plans and other corporate governance changes remain subject to shareholder approval at its annual general meeting scheduled for May 2026.
Final audited financial results for the fourth quarter and full year 2025, along with detailed guidance and pipeline updates, will be provided in argenx's upcoming earnings release.