argenx SE

ARGX

Held by 12 specialist biotech funds

High Convergence

12 funds opened new positions. Next phase2 readout (Azacitidine): Aug 2023. Short interest: 3.3% of float.

BiotechnologyCEO: Timothy Van HauwermeirenIPO: 2017Website ↗

argenx SE, a biotechnology company, engages in the developing of various therapies for the treatment of autoimmune diseases in the United States, Japan, Europe, Middle East, Africa, and China. Its lead product candidate is efgartigimod for the treatment of patients with myasthenia gravis, immune thrombocytopenia, pemphigus vulgaris, generalized myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, thyroid eye disease, bullous pemphigoid, myositis, primary sjögren's syndrome, post-covid postural orthostatic tachycardia syndrome, membranous nephropathy, lupus nephropathy, anca-associated vasculitis, and antibody mediated rejection; ENHANZE SC; Empasiprubart for multifocal motor neuropath, delayed graft function, and dermatomyositis; and ARGX-119 for congenital myasthenic syndrome and amyotrophic lateral sclerosis. The company is developing ARGX-213 targets FcRn; ARGX-121 and ARGX-220 targets immune system; ARGX-109 targets IL-6; ARGX-118 for inflammation; and ARGX-109, as well as cusatuzumab, ARGX-112, ARGX-114, and ARGX-115. It owns VYVGART; VYVGART HYTRULO; VYVDURA; ARGENX; ABDEG; NHANCE; SIMPLE ANTIBODY; and ARGENXMEDHUB. The company has strategic partnership with AbbVie S.À.R.L., Zai Lab Limited, and LEO Pharma A/S; and collaboration and license agreement with Genor Biopharma Co. Ltd, Université Catholique de Louvain, Sopartec S.A., NYU Langone Health, Leiden University Medical Center, AgomAb Therapeutics NV, Broteio Pharma B.V., VIB vzw, University of Texas, BioWa, Inc., and Shire International GmbH. It has collaboration agreement with Genmab A/S to discover, develop, and commercialize novel therapeutic antibodies with applications in immunology and oncology, as well as a strategic collaboration with IQVIA Holdings Inc. to provide safety systems and services. argenx SE was incorporated in 2008 and is based in Amsterdam, the Netherlands.

Catalysts

Phase 2Aug 15, 2023AzacitidineLeukemia, Myeloid, AcuteNCT04023526

Phase 3Q2 2025Efgartigimod IVGeneralized Myasthenia Gravis, g MG, Myasthenia Gravis, GeneralizedNCT06298552

Phase 2Q4 2025ARGX-117Delayed Graft FunctionNCT05907096

Phase 3Q1 2026Myasthenia Gravis, OcularNCT06558279

Phase 2Q3 2026EfgartigimodEpidermolysis Bullosa (EB), Epidermolysis Bullosa Acquisita, Recessive Dystrophic Epidermolysis BullosaNCT07011589

Phase 2Q3 2026ARGX-119Amyotrophic Lateral SclerosisNCT06441682

Phase 3Q3 2026Efgartigimod PH20 SCGeneralized Myasthenia GravisNCT06392386

Primary: Efgartigimod serum concentrations as input for compartmental, model-driven analysis to determine age and size dependency of Clearance (CL) (Up to 12 weeks)Enrollment:Target 12Sites: 20NA, TREATMENT

Phase 3Q3 2026EmpasiprubartMultifocal Motor Neuropathy (MMN), MMNNCT06742190

Phase 3Q4 2026efgartigimod PH20 SCPrimary Immune ThrombocytopeniaNCT04812925

Phase 2Q4 2026Empasiprubart IVDermatomyositis, MyositisNCT06284954

Phase 3Q4 2026EFG PH20 SCActive Idiopathic Inflammatory Myopathy, Myositis, DermatomyositisNCT05523167

Phase 2Q4 2026Efgartigimod AlfaOptic NeuritisNCT06453694

Primary: Recruitment Rate (2 years)Enrollment:Target 20Sites: 2RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Jan 6, 2027efgartigimod administrationMyasthaenia GravisNCT06765161

Phase 2Q1 2027Systemic Sclerosis (SSc)NCT06655155

Phase 3Q1 2027Efgartigimod IVGeneralized Myasthenia GravisNCT04833894

Phase 2Q2 2027Efgartigimod PH20 SCChronic Inflammatory Demyelinating Polyneuropathy (CIDP)NCT04280718

Primary: Incidence of treatment-emergent adverse events and serious adverse events (Up to 48 weeks per cycle (each cycle is 48 weeks) until the end of the study)Enrollment:229/229Sites: 147NA, TREATMENT

Phase 3Q3 2027Efgartigimod PH20 SCPrimary Sjogrens DiseaseNCT06684847

Phase 3Q3 2027empasiprubartChronic Inflammatory Demyelinating Polyneuropathy, CIDP, CIDP - Chronic Inflammatory Demyelinating PolyneuropathyNCT06920004

Phase 2Q3 2027Antibody-mediated RejectionNCT06503731

Phase 3Q4 2027Empasiprubart IVChronic Inflammatory Demyelinating Polyneuropathy, CIDP, Chronic Inflammatory Demyelinating PolyradiculoneuropathyNCT07091630

Phase 2Q1 2028Efgartigimod IVACh R-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis, MGNCT07284420

Phase 3Q2 2028Efgartigimod IVPrimary Immune Thrombocytopenia (ITP)NCT06544499

Phase 3Q2 2028Efgartigimod PH20 SCGraves' Disease, Graves DiseaseNCT07570316

Phase 3Q3 2028Efgartigimod PH20 SCMyositis, Active Idiopathic Inflammatory Myopathy, DermatomyositisNCT05979441

Phase 3Q4 2028Efgartigimod IVImmune Thrombocytopenia (ITP), ITP - Immune Thrombocytopenia, ITPNCT07194850

Phase 2Q2 2029ARGX-119 IVSpinal Muscular Atrophy (SMA)NCT07287982

Phase 3Q3 2029Efgartigimod IV or Efgartigimod PH20 SCGeneralized Myasthenia Gravis, g MGNCT05374590

Phase 2Q3 2029ARGX-117Multifocal Motor Neuropathy (MMN)NCT05405361

Recent News & Research

PubMed

Structure-function analysis of empasiprubart, a calcium- and pH-dependent clinical phase complement C2 blocking antibody.

I don't have access to this specific article (published December 2026), so I cannot provide an accurate summary of its findings or clinical implications for empasiprubart. To give you actionable analysis, I would need either: - The article text or abstract - Key data points (efficacy, safety, mechanism details) - Clinical trial results or competitive positioning discussed If you can share the article or its abstract, I can provide a focused 2-3 sentence summary addressing the mechanism's significance for empasiprubart's commercial potential and how it positions argenx relative to other C2 inhibitors in development.

Dec 1, 2026

PubMed

Effectiveness and safety of efgartigimod in myasthenia gravis: A meta-analysis of different antibody subtypes.

# Summary for ARGX Investors This meta-analysis evaluates efgartigimod's effectiveness and safety profile across different antibody subtypes in myasthenia gravis (MG), argenx's lead commercial indication. The findings provide comparative efficacy/safety data that could support label expansion, inform patient stratification strategies, or strengthen reimbursement arguments by demonstrating consistent benefit across MG patient populations. **Investor relevance:** Meta-analyses strengthen the clinical evidence base for approved drugs and can unlock additional patient segments or geographic markets, potentially expanding the commercial opportunity beyond the current approved indication and supporting premium pricing arguments.

May 7, 2026

PubMed

Single-institution experience with efgartigimod in patients with GFAP astrocytopathy: Treatment response and adverse events.

# Investment Summary: Efgartigimod in GFAP Astrocytopathy This single-institution case series evaluates efgartigimod (argenx's lead asset) in GFAP astrocytopathy, a rare autoimmune neurological disorder distinct from its FDA-approved indication in myasthenia gravis. The data on treatment response and safety profile in this off-label use case could inform potential label expansion opportunities, though single-institution experience carries limited statistical weight for regulatory decisions. For argenx investors, this represents exploratory evidence for efgartigimod's broader utility in IgG-mediated autoimmune conditions, but commercial impact depends on larger, controlled trials and regulatory pathway clarity in this niche indication. **Key caveat**: Investors should await multi-center evidence and commercial viability assessment before assigning material value to potential GFAP astrocytopathy expansion.

May 1, 2026

PubMed

Real-world evidence on utilization and clinical outcomes of efgartigimod in patients with generalized myasthenia gravis.

# Investment Summary: Efgartigimod Real-World Evidence in gMG This real-world evidence study demonstrates clinical outcomes and usage patterns of argenx's efgartigimod (Vyvgart) in generalized myasthenia gravis patients outside controlled trial settings, providing validation of efficacy durability and patient population characteristics that inform market penetration. Real-world data strengthens reimbursement arguments, supports label expansion discussions, and helps establish efgartigimod's competitive position against both standard of care and emerging gMG therapies. The utilization patterns documented will be critical for revenue modeling accuracy and understanding which patient subgroups derive greatest benefit—directly impacting peak sales forecasts for argenx's lead commercial asset.

Apr 19, 2026

PubMed

Efgartigimod as Rescue Therapy for PD-1 Inhibitor-Associated Myasthenia Gravis, Myocarditis, and Myositis (MMM) Syndrome: A 2-Case Report and Literature Review.

# Investment Summary: Efgartigimod in Checkpoint Inhibitor-Associated Autoimmunity This case report documents efgartigimod's potential utility as a rescue therapy for serious immune-related adverse events (irAEs) induced by PD-1 inhibitors, specifically the rare myasthenia gravis-myocarditis-myositis syndrome. The finding is clinically significant because these irAEs currently lack established treatment protocols and can be life-threatening, creating an addressable unmet need in oncology patients receiving immunotherapy. For argenx, this represents a potential label expansion opportunity that could broaden efgartigimod's commercial applicability beyond its approved MG indication into the growing oncology-immunotherapy space, though validation would require larger prospective studies given the case report format. **Investor note:** This is exploratory data with limited immediate commercial impact, but successful development in this indication could represent

Apr 16, 2026

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