Study met primary endpoint (p-value = 0.012)First registrational study to specifically evaluate a targeted treatment for patients living with ocular MG Results support planned Supplemental Biologics License Application (sBLA) submission to U.S. Food and Drug Administration (FDA) to expand label into oMG Regulated Information – Inside Information  February 26, 2026, 6:30 AM CET    Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives o ...

Core Insights - The FDA has accepted a supplemental Biologics License Application (sBLA) for VYVGART (efgartigimod alfa-fcab) for treating adults with acetylcholine receptor antibody (AChR-Ab) seronegative generalized myasthenia gravis (gMG), with a target action date of May 10, 2026 [1][2] Company Overview - Argenx SE is a global immunology company focused on improving the lives of individuals suffering from severe autoimmune diseases [1][18] - The company is developing VYVGART, the first approved neonatal Fc receptor (FcRn) blocker, and is exploring its potential across various serious autoimmune diseases [18] Clinical Study Details - The sBLA is supported by data from the Phase 3 ADAPT SERON study, which demonstrated a statistically significant improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score compared to placebo after four weeks [2][3] - The study included 119 participants and evaluated the safety and efficacy of efgartigimod in adults with AChR-Ab seronegative gMG across multiple regions [5] Efficacy and Safety - In the overall population, patients treated with VYVGART showed a clinically meaningful improvement of 3.35 points in MG-ADL total score at week 4 [3] - VYVGART was well-tolerated, with a safety profile consistent with previous studies, and no new safety concerns were identified [4] Patient Population - Approximately 20% of gMG patients are AChR-Ab seronegative, lacking detectable antibodies against AChR, MuSK, or LRP4, and currently have no approved treatments available [7][8]