argenx SE (ARGX) announced that the U.S. FDA has approved a label expansion for VYVGART (efgartigimod alfa-fcab) and VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG).
VYVGART Hytrulo was initially approved by the FDA on June 20, 2023, for subcutaneous use in gMG, following the original intravenous formulation approval in December 2021.
The approval extends use of VYVGART and VYVGART Hytrulo to all adult gMG serotypes including anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative patients. Data from the Phase 3 ADAPT SERON study, the largest to date in antibody-negative gMG, showed patients treated with VYVGART experienced rapid, significant and sustained improvements in symptoms such as speech, vision, swallowing, and physical function compared to placebo.
The study met its primary endpoint, demonstrating a statistically significant improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living) total score at week 4 (p=0.0068). Patients achieved a mean 3.35-point improvement from baseline, with benefits observed across subsequent treatment cycles and all serotypes studied. Safety was consistent with the established profile in AChR-Ab positive gMG.
Argenx reported $1.3 billion in global net sales of the VYVGART franchise in Q1 2026, compared with $0.8 billion in Q1 2025 representing 63% year-over-year growth. Full-year 2025 VYVGART generated $4.2 billion, representing 90% growth over $2.2 billion in 2024. The strong uptake of VYVGART IV and VYVGART Hytrulo underscores their commercial momentum alongside regulatory expansion.
With this approval, VYVGART and VYVGART Hytrulo become the first and only therapies available for all gMG patients regardless of antibody status, delivering the broadest MG label to date.
Generalized myasthenia gravis is a rare autoimmune disease that causes debilitating muscle weakness, affecting vision, movement, speech, swallowing, and even breathing. Approximately 20% of patients lack detectable AChR antibodies, making diagnosis and treatment more challenging.
ARGX has traded between $510.05 and $934.62 over the past year. The stock closed Friday's trading (May 8, 2026) at $782.17, down 0.65%. In pre-market trading, the stock is at $802.18, up 2.56%.
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