Immunology pioneer argenx (NASDAQ:ARGX) delivered its first-ever year of operating profitability in 2025, powered by a massive commercial expansion of its flagship FcRn blocker, VYVGART.
The company reported full-year product net sales of $4.2 billion, a nearly 90% increase over the previous year, resulting in approximately $1.1 billion in operating income.
The financial milestone underscores the rapid global adoption of VYVGART across its approved indications, including generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP).
By year-end, the company was reaching approximately 19,000 patients globally, nearly doubling its reach from 2024.
Beyond the balance sheet, argenx cleared significant clinical and regulatory hurdles.
The company announced positive topline results from the Phase 3 ADAPT OCULUS trial in ocular myasthenia gravis (oMG), which met its primary endpoint with statistically significant improvements in patient-reported outcomes.
Furthermore, the FDA has set a PDUFA target action date of May 10, 2026, for the company’s supplemental Biologics License Application (sBLA) for seronegative gMG—a subset of patients currently lacking targeted therapeutic options.