• Biologics License Application for efgartigimod in generalized myasthenia gravis on track to be submitted to U.S. Food and Drug Administration by end of year
• Full data from ADAPT trial to be presented at upcoming medical meeting in 2020
• Cusatuzumab development strategy aligned with evolving AML treatment landscape to focus on combination with venetoclax and azacitidine
• €1.9 billion in cash and cash equivalents and current financial assets strongly support commercial launch preparation of efgartigimod
• Management to host conference call today at 2:30 pm CEST (8:30 am ET)

July 30, 2020Breda, the Netherlands / Ghent, Belgium – 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 half year 2020 financial results and provided a second quarter business update and outlook for the remainder of the year.

“We are proud of the progress we have made during the first half of 2020 to advance our immunology pipeline and validate our first-in-class FcRn antagonist, efgartigimod. We announced positive topline results from the Phase 3 ADAPT trial, furthering our conviction that efgartigimod has the potential to significantly improve the standard of care for people with gMG as well as several other autoantibody-driven diseases. We are focused on our planned 2021 U.S. commercial launch of efgartigimod to bring this therapy to patients as quickly as possible and to advance on our ‘argenx 2021’ vision,” said Tim Van Hauwermeiren, CEO of argenx.

"We also remain committed to advancing our robust pipeline, including our late-stage efgartigimod trials in additional autoimmune indications and our early-stage candidates from our Immunology Innovation Program. Regarding cusatuzumab, which we are currently developing in a global collaboration with Janssen, as clinical trial sites re-open, we are taking the opportunity to evaluate the most appropriate development strategy given the rapidly evolving treatment landscape, ” continued Mr. Van Hauwermeiren.

SECOND QUARTER 2020 AND RECENT BUSINESS UPDATE

argenx continues to execute on its “argenx 2021” vision to become a fully integrated, global immunology company. The company continues to implement measures across the organization and in the operations of globally run clinical trials to minimize the impact of COVID-19 on employees, patients and their communities, physicians and ongoing business priorities.

Commercial preparations underway to support potential approval and launch of argenx’s first-in-class FcRn antagonist, efgartigimod, in its first indication, generalized myasthenia gravis (gMG).

• Biologics License Application (BLA) on track to be filed with the U.S. Food and Drug Administration (FDA) by the end of 2020 with an expected U.S. commercial launch in 2021
• Japanese Marketing Authorization Application (J-MAA) expected to be filed with the Pharmaceuticals and Medical Devices Agency (PMDA) in the first half of 2021 with an expected efgartigimod launch in gMG in Japan following the U.S. commercial launch
• Commercial infrastructure readiness activities, including with global supply chain, are on track for launch timeline in the U.S. and Japan

In May, argenx reported positive topline data from the Phase 3 ADAPT trial showing efgartigimod was well-tolerated and able to drive responses that support plans to offer individualized dosing to gMG patients.  

• ADAPT met its primary endpoint showing 67.7% of acetylcholine receptor-antibody positive (AChR-Ab+) gMG patients were responders on the Myasthenia Gravis Activities of Daily Living (MG-ADL) score compared with 29.7% on placebo (p