• VYVGART and VYVGART Hytrulo are the first and only approved treatments for all serotypes of adult patients living with gMG – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative
  • Patients treated with VYVGART in the ADAPT SERON study experienced rapid, significant and sustained symptom improvements that continued with ongoing treatment
  • Approval advances argenx's commitment to address the unique needs of every MG patient, delivering the broadest MG label to date



     

May 8, 2026, 5:20 PM CET

Amsterdam, the Netherlands – argenx SE ((Euronext &, NASDAQ:ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced the U.S. Food and Drug Administration (FDA) 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). The approved supplemental Biologics License Application (sBLA) expands VYVGART's indication to include all serotypes of adult patients living with gMG – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative.

The approval is based on data from the Phase 3 ADAPT SERON study, the largest study to date of patients with gMG who do not have detectable anti-acetylcholine receptor antibodies (AChR-Ab) across three serotypes – anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative. The overall population of patients in the study treated with VYVGART showed rapid, significant and sustained improvements in their gMG symptoms, including speech, vision, physical function and swallowing, among others. In addition, VYVGART was well tolerated across serotypes, with safety consistent with the established profile in patients with anti-AChR-Ab positive gMG.