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Highlights

  • Generated $790 million in Q1 2025 global net product sales for VYVGART and VYVGART SC
  • Positive regulatory milestones achieved for self-injection PFS in U.S., EU, with decisions pending in Japan and Canada
  • Advancing 20 clinical trials across pipeline programs targeting autoimmune diseases

argenx SE [Euronext & Nasdaq: ARGX], a biotechnology firm focused on autoimmune diseases, announced its financial results for the first quarter of 2025, alongside updates on its expanding pipeline and regulatory progress. The company reported $790 million in global net product sales from VYVGART® and its subcutaneous version, VYVGART SC, reflecting a 99% increase year-over-year and a 7% rise from the previous quarter.

The company’s “Vision 2030” strategy aims to treat 50,000 patients globally across 10 approved indications. As part of this effort, argenx continues to expand the reach of VYVGART, which is currently approved for generalized myasthenia gravis (gMG), primary immune thrombocytopenia (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP) in select markets.

Recent regulatory developments include the approval of VYVGART-SC as a pre-filled syringe (PFS) in the U.S. and EU, enabling patients in both regions to self-administer treatment. The first patients have now received the SC formulation in the U.S. and Germany. Regulatory decisions are expected later this year in Japan and Canada for the same formulation in gMG and CIDP.

argenx is also advancing a broad clinical pipeline, including 10 Phase 2 and 10 Phase 3 trials involving candidates such as efgartigimod, empasiprubart, and ARGX-119. Key data readouts anticipated in 2025 and 2026 include results from studies targeting seronegative, ocular, and pediatric MG, as well as a Phase 4 CIDP switch study evaluating transitions from IVIg to VYVGART SC.

In addition, argenx continues to generate post-marketing evidence across indications to inform future regulatory submissions. For instance, the ADVANCE-NEXT trial, evaluating VYVGART IV in ITP, is expected to deliver topline data in the second half of 2026, supporting a potential submission to the FDA.