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argenx argenx Reports First Quarter 2021 Financial Results and Provides Business Update Japanese Marketing Authorization Application ( J - MAA ) for efgartigimod accepted for review by Japan's Pharmaceuticals and Medical Device Agency ( PMDA ) for generalized myasthenia gravis May 14 , 2021 ( gMG ) Management to host conference call today at 2:30 pm CEST ( 8:30 am ET ) - Breda , the Netherlands argenx ( Euronext & Nasdaq : ARGX ) , a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer , today reported financial results for the first quarter 2021 and provided a business update . " We've had a strong start to 2021 with the acceptance for review of the BLA and J - MAA for efgartigimod in gMG by the regulatory agencies in the U.S. and Japan . The submissions in China and the EU are on track and we are well - positioned for a global launch of our first - in - class FcRn antagonist . We are building an exceptional team with significant launch experience in neurology and rare disease and hope to reach patients this year , " said Tim Van Hauwermeiren , Chief Executive Officer of argenx . " Efgartigimod has the potential to help people living with gMG as well as several other severe autoimmune diseases mediated by IgG autoantibodies . Our team is advancing registrational trials across four indications with plans to start enrollment in two additional efgartigimod indications this year . We are also broadening our reach within autoimmunity with our first - in - class C2 inhibitor , ARGX- 117 , from which we will have Phase 1 data mid - year . To complement our clinical pipeline , we continue to invest in our discovery capabilities through our Immunology Innovation Program and strategic technology partnerships that position us well to generate long - term value for shareholders . We are closer each day to building an integrated , innovative , global immunology organization with the goal of impacting the lives of patients , " concluded Mr. Van Hauwermeiren . FIRST QUARTER 2021 AND RECENT BUSINESS UPDATE Commercial preparations on - track for global launch of IV efgartigimod for gMG , including regulatory submissions , initial salesforce hires and key stakeholder engagement efforts - Biologics License Application ( BLA ) for IV efgartigimod for treatment of gMG accepted for review by U.S. Food and Drug Administration ( FDA ) with target action date of December 17 , 2021 under Prescription Drug User Fee Act ( PDUFA ) J - MAA submitted to Japan's PMDA and accepted for review with anticipated Japan commercial launch in 2022 MAA expected to be filed with European Medicines Agency ( EMA ) in second half of 2021 Zai Lab Limited to discuss potential accelerated regulatory pathway for approval in China with National Medical Products Administration ( NMPA ) Commercial readiness activities on - track , including :