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argenx reports Q3 2021 financial results and provides business update

October 31, 2021
Life sciences

argenx (Euronext & Nasdaq: ARGX), a global immunology companycommitted 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
  • Zai Lab on track with expected regulatory discussions with National Medical Products Administration (NMPA) for approval in China
  • Signed exclusive partnership agreement with Medison to commercialize efgartigimod for gMG in Israel; under agreement, Medison will also be responsible for seeking requisite regulatory approvals
  • Field teams onboard in U.S. and Japan, including 70 U.S. and 24 Japan sales representatives

READ MORE

by argenx, Press Release

Source: argenx.com

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