ARGX - argenx Highlights 2024 Strategic Priorities | Benzinga
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."
2024 Strategic Priorities
argenx will focus on three strategic priorities in 2024 to drive sustainable long-term growth, including:
- Reach more patients with VYVGART by building upon its strong commercial foundation to address ongoing unmet patient need, broaden the MG opportunity, and expand into CIDP
- Advance its extensive pipeline through new data readouts, creating multiple opportunities to demonstrate transformative clinical benefit
- Leverage its repeatable innovation engine, driving pipeline growth through its Immunology Innovation Program
Reach More Patients with VYVGART
VYVGART (efgartigimod alfa fcab) is a first-in-class antibody fragment targeting the neonatal Fc receptor (FcRn) and is now approved in more than 30 countries globally. VYVGART subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) is approved in the U.S. (as VYVGART Hytrulo) and Europe, making VYVGART the only gMG treatment available as both an IV and simple SC injection. argenx is planning to reach more patients commercially in 2024 through its multi-dimensional expansion efforts. argenx will work to reach patients earlier in the MG treatment paradigm and improve the lives of new MG patient populations through additional global regulatory approvals, and the expansion of uses to treat additional autoimmune indications.
- Regulatory approval decisions of VYVGART for gMG expected in Switzerland, Australia, Saudi Arabia and South Korea by end of 2024
- Through strategic collaboration with Zai Lab, VYVGART to be included on China's 2023 National Reimbursement Drug List (NRDL), starting in January 2024
- Decision on approval of VYVGART SC for gMG in Japan expected in first quarter of 2024 and in China through Zai Lab by end of 2024
- Decision on approval of VYVGART for primary immune thrombocytopenia (ITP) in Japan expected in first quarter of 2024
- Supplemental Biologics License Application (sBLA) submitted to FDA for VYVGART Hytrulo for CIDP with priority review voucher (PRV); if approved, launch expected mid-2024
- Regulatory submissions of VYVGART SC for CIDP in Japan, Europe, China and Canada expected in 2024
- Registrational studies to expand VYVGART label into broader MG populations, including in seronegative patients, to start in 2024
- Update on pre-filled syringe development expected in first half of 2024; ongoing studies to support potential approval in gMG and CIDP in 2024
Advance Current Pipeline through Upcoming Data Readouts
argenx continues to demonstrate breadth and depth within its immunology pipeline and is advancing multiple pipeline-in-a-product candidates. With efgartigimod, argenx is solidifying its leadership in FcRn and ...