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     245  0 Kommentare argenx Highlights 2024 Strategic Priorities


    Reported $1.2 billion in preliminary* full-year 2023 global net product sales

    Submitted sBLA to FDA for VYVGART Hytrulo for CIDP with priority review voucher (PRV); if approved, launch expected mid-2024

    Reported positive data from Phase 2 ARDA study establishing proof-of-concept for empasiprubart in MMN

    Data from six Phase 2 proof-of-concept trials expected by end of 2024

    Nominated four new pipeline candidates with IND filings expected by end of 2025

    January 8, 2024, 7:00 AM CET

    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 reported preliminary financial results for the full-year 2023, including global net product sales (inclusive of both VYVGART and VYVGART Hytrulo), and announced its strategic priorities for 2024.

    “In 2023, we reached more than 6,000 patients globally, making VYVGART available to gMG patients around the world,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “We continued to invest in and demonstrate the sustainability of our business by successfully launching our subcutaneous VYVGART product, and are poised for continued expansion in gMG and beyond in 2024. argenx is delivering on its promise to transform how the world understands autoimmunity. It is with this commitment in mind that we submitted our sBLA for VYVGART Hytrulo in CIDP and, if approved, expect to launch in the U.S. in mid-2024. We will continue to be aggressive in advancing our pipeline this year and expect to report efgartigimod data from six Phase 2 studies in 2024, and to further develop empasiprubart in MMN. Through sustained investment in our IIP, we expect to see repeat value creation, and plan to submit four new INDs by the end of 2025.”

    “Two years ago, argenx’s key goal was to launch efgartigimod in the U.S. Today, we have built a formidable global commercial organization with product approvals in over 30 countries worldwide and a vibrant pipeline of promising new therapeutics to address immune-mediated diseases. We have forged important partnerships that support our mission to advance the human understanding of immunology to best benefit patients. argenx is well positioned for sustained growth throughout 2024 and well into the future.” 

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    argenx Highlights 2024 Strategic Priorities Reported $1.2 billion in preliminary* full-year 2023 global net product sales Submitted sBLA to FDA for VYVGART Hytrulo for CIDP with priority review voucher (PRV); if approved, launch expected mid-2024 Reported positive data from Phase 2 ARDA …