Amsterdam, Netherlands – Argenx SE, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) injection for subcutaneous (SC) use for the treatment of adult patients with...
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Amsterdam, Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) approved VYVGART (efgartigimod alfa) for intravenous (IV) use in adults with primary immune thrombocytopenia...
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 that the European Commission (EC) approved VYVGART® (efgartigimod alfa) 1000mg for subcutaneous (SC) injection as a monotherapy for the treatment of adult patients...
Amsterdam, Netherlands – Argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for VYVGART Hytrulo (efgartigimod...
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 that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for VYVGART® (IV: efgartigimod...
VYVGART® is first-and-only targeted IgG Fc-antibody fragment for CIDP First novel mechanism of action for CIDP treatment in more than 30 years CHMP positive opinion based on ADHERE data, the largest ever CIDP clinical trial European Commission (EC) decision on marketing authorization application (MAA) expected within approximately two months Amsterdam, the...
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 positive topline data from the pivotal ADAPT SERON study of VYVGART® (IV: efgartigimod alfa-fcab). The study met its primary endpoint (p-value=0.0068), demonstrating that...
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 positive topline results from the Phase 3 ADAPT OCULUS study evaluating VYVGART® (efgartigimod alfa and hyaluronidase-qvfc) in adults with ocular myasthenia gravis (oMG)....
ADAPT-NXT data demonstrate consistent, sustained disease control across dosing schedules, further supporting individualized VYVGART dosing for gMG patients ADHERE+ oral presentation features long-term CIDP data demonstrating VYVGART Hytrulo’s durable efficacy, sustained functional improvements and favorable safety profile argenx continues to advance a robust neuromuscular pipeline of clinical candidates; first-in-human data...
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 presentation of new data further highlighting the efficacy and safety of VYVGART® (IV: efgartigimod alfa-fcab and SC or Hytrulo: efgartigimod alfa and...