argenx SE is a Dutch‑Belgian biotechnology company focused on developing and commercializing antibody‑based therapies for immune‑mediated diseases. Founded in 2008, the company operates from the Netherlands and Belgium and is listed on Euronext Brussels and Nasdaq under the ticker ARGX.
Its lead product is efgartigimod, an FcRn antagonist marketed as VYVGART and VYVGART Hytrulo, approved in multiple regions for the treatment of generalized myasthenia gravis; the subcutaneous co‑formulation (Hytrulo) is also approved in the United States for chronic inflammatory demyelinating polyneuropathy (CIDP). argenx maintains a pipeline of antibody programs targeting autoimmune indications across neurology, hematology, and dermatology, progressing candidates through clinical development and working with external partners for manufacturing and commercialization.
Also known as arGEN-X and argenx SE.
None yet. When a new project in the record names argenx as owner, partner or investor, it shows here.
Adds macrocyclic peptide platform to broaden immunology toolbox, enabling oral and long‑acting drug development; deal up to $1.15 billion.
Phase 3 ALKIVIA met primary and key secondary endpoints in combined IMNM and DM; argenx will file an sBLA for IMNM by end‑2026 following Breakthrough Therapy designation.
VYVGART sales up 54% YoY; sBLA filings and Phase‑3 readouts scheduled through Dec 2026–2027; cash $3.7B and combined R&D+SG&A guide ≈$4B for 2026.
Phase 3 ALKIVIA shows clinically meaningful, rapid improvements in IMNM and dermatomyositis, seen by Week 4 and sustained to Week 52; primary endpoint met (TIS +15.4).
Independent Data Monitoring Committee advised stopping the trial for futility after an interim analysis; safety remained consistent and no new signals were seen.
FB102, a CD122 inhibitor, met the primary histology endpoint (Vh:Cd change; p=0.0176) versus placebo and showed aligned symptom and inflammatory benefits with no new safety signals.
Clinical, long-term and real‑world data show deeper ocular MG responses, one‑year efficacy in AChR‑Ab–negative MG, benefits of earlier treatment, CIDP durability and pipeline progress.
Adds FB102, a first‑in‑class anti‑CD122 with clinical proof‑of‑concept in vitiligo and celiac disease; $77 per‑share tender offer completed and merger closed.
