Page 1

argenx argenx Reports Third Quarter 2021 Financial Results and Provides Business Update – U.S. and Japan commercial teams fully staffed ahead of potential launches of efgartigimod in generalized myasthenia gravis ( gMG ) – - Signed partnership agreement with Medison for distribution of efgartigimod in Israel - Wim Parys , M.D. to retire as Chief Medical Officer in March 2022 - Management to host conference call today at 2:30 pm CEST ( 8:30 am ET ) - October 28 , 2021 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 announced its third quarter 2021 financial results and provided a business update and outlook for the remainder of the year . " With three parallel regulatory reviews in our key priority territories of the U.S. , Japan and the EU and the simultaneous build - out of our respective commercial organizations , we are well - positioned for the planned global launch of efgartigimod for the treatment of generalized myasthenia gravis . In order to optimize our strategy to make efgartigimod available to patients in need across the world , we are pursuing innovative partnerships , such as the strategic partnership with Zai Lab in China and the agreement with Medison in Israel which we are excited to announce today , " said Tim Van Hauwermeiren , Chief Executive Officer of argenx . " As part of our commitment to becoming a fully - integrated , global immunology company , we are expanding our efgartigimod development plan to be in at least 15 indications by 2025 while also advancing a series of additional high - potential programs emerging from our Immunology Innovation Program . This includes a first - in - class C2 inhibitor , ARGX - 117 , which is on track to begin the first Phase 2 trial in multifocal motor neuropathy patients by the end of this year . Our growing commercial infrastructure along with our expanding pipeline ambitions provide considerable opportunity for argenx to deliver long - term , sustainable growth , ” concluded Mr. Van Hauwermeiren . THIRD QUARTER 2021 AND RECENT BUSINESS UPDATE Three global regulatory reviews ongoing for FcRn antagonist efgartigimod for the treatment of gMG Biologics License Application ( BLA ) under review with U.S. Food and Drug Administration ( FDA ) with target action date of December 17 , 2021 under Prescription Drug User Fee Act ( PDUFA ) Marketing Authorization Application ( J - MAA ) under review with Japan's Pharmaceuticals and Medical Devices Agency ( PMDA ) with anticipated approval in first quarter of 2022 MAA under review with European Medicines Agency ( EMA ) with anticipated approval in second half of 2022