argenx SE

ARGX

Held by 12 specialist biotech funds

High Convergence

12 funds opened new positions. Next phase2 readout (Azacitidine): Aug 2023. Short interest: 2.2% of float.

BiotechnologyCEO: Karen MasseyIPO: 2017Website ↗

argenx SE, a biotechnology company established in Amsterdam, the Netherlands, in 2008, is dedicated to developing innovative therapies primarily for autoimmune diseases. The company's operations span across key global markets, including the United States, Japan, Europe, the Middle East, Africa, and China. Its leading investigational therapy is efgartigimod, which is being developed to address a broad range of conditions. These include generalized myasthenia gravis, immune thrombocytopenia, pemphigus vulgaris, 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. Also noted in connection with its lead product efforts is ENHANZE SC. The company's extensive development pipeline features several other promising candidates. Empasiprubart is in development for multifocal motor neuropathy, delayed graft function, and dermatomyositis. ARGX-119 is being investigated for congenital myasthenic syndrome and amyotrophic lateral sclerosis. Further pipeline assets include ARGX-213, which targets FcRn; ARGX-121 and ARGX-220, both designed to modulate the immune system; ARGX-109, which targets IL-6; and ARGX-118, developed for inflammatory indications. argenx is also advancing cusatuzumab, ARGX-112, ARGX-114, and ARGX-115. The company’s portfolio encompasses several proprietary products and brands, such as VYVGART, VYVGART HYTRULO, VYVDURA, ARGENX, ABDEG, NHANCE, SIMPLE ANTIBODY, and ARGENXMEDHUB. Strategic collaborations are integral to argenx's business model. It maintains partnerships with AbbVie S.À.R.L., Zai Lab Limited, and LEO Pharma A/S, alongside numerous collaboration and license agreements with entities including 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. A specific collaboration with Genmab A/S focuses on the discovery, development, and commercialization of novel therapeutic antibodies for immunology and oncology applications. Additionally, argenx has a strategic collaboration with IQVIA Holdings Inc. for the provision of safety systems and related services.

Catalysts

Phase 2PositiveQ4 2017ARGX-113Myasthenia GravisNCT02965573

Primary: Number of Patients With Treatment Emergent Adverse Events (TEAES) and Treatment Emergent Serious Adverse Events (SAEs) (Day 1 to Day 78)Enrollment:24/24Sites: 19RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q2 2019ARGX-113Primary Immune ThrombocytopeniaNCT03102593

Primary: Incidence and severity of serious adverse events (SAEs). (After the first administration of Investigational Medicinal Product day 1 to 30 days of a patient's last visit.)Enrollment:38/38Sites: 30RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ2 2020ARGX-113Generalized Myasthenia GravisNCT03669588

Primary: Percentage of MG-ADL Responders During Cycle 1 (C1); Analyzed in the AChR-Ab Seropositive Population (Baseline up to Day 63 (end of TC1))Enrollment:167/167Sites: 66RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q3 2021efgartigimodPrimary Immune Thrombocytopenia (ITP)NCT04274452

Primary: Number of cumulative weeks over the planned 24 week treatment period with platelet counts of ≥50×10^9/L in patients with chronic ITP. (Up to 24 weeks)0RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ4 2021efgartigimod PH20 SCGeneralized Myasthenia GravisNCT04735432

Primary: Percent Change From Baseline in Total IgG Levels at Day 29 (mITT Analysis Set) (From week 0 to week 4)Enrollment:110/110Sites: 47RANDOMIZED, TREATMENT

Phase 3PositiveQ1 2022efgartigimodPrimary Immune ThrombocytopeniaNCT04188379

Primary: Percentage of Participants With Chronic ITP With a Sustained Platelet Count Response Defined as Achieving Platelet Counts of at Least 50×10^9/L for at Least 4 of the 6 Visits Between Week 19 and 24 of the Trial. (From Week 19 up to Week 24)Enrollment:131/131Sites: 121RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ2 2022ARGX-113Generalized Myasthenia GravisNCT03770403

Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious AEs, TEAEs Leading to Study Drug Discontinuation and Fatal TEAE in AChR-Positive Participants (TEAEs were collected from the start of first administered study treatment (Day 1) up to end of follow-up, approximately up to 3 years)Enrollment:151/151Sites: 52NA, TREATMENT

Phase 2Aug 15, 2023AzacitidineLeukemia, Myeloid, AcuteNCT04023526

Primary: Percentage of Participants With Complete Remission (CR) (Up to 3 years and 5 months)Enrollment:103/103Sites: 56RANDOMIZED, TREATMENT

Phase 3Q3 2023efgartigimod PH20 SCPemphigus Vulgaris, Pemphigus FoliaceusNCT04598451

Phase 3PositiveQ3 2023Efgartigimod IVGeneralized Myasthenia Gravis, MG - Myasthenia Gravis, g MGNCT04980495

Phase 3PositiveQ4 2023Efgartigimod PH20 SCPrimary Immune ThrombocytopeniaNCT04687072

Phase 2Q1 2024EfgartigimodPrimary Sjögren's SyndromeNCT05817669

Phase 3NegativeQ1 2024efgartigimod PH20 SCPemphigus Vulgaris, Pemphigus FoliaceusNCT04598477

Phase 2Q2 2024EfgartigimodPostural Orthostatic Tachycardia SyndromeNCT05633407

Phase 2Q2 2024ARGX-117Multifocal Motor NeuropathyNCT05225675

Phase 2NegativeQ3 2024efgartigimod IVMembranous NephropathyNCT05810961

Phase 2NegativeQ3 2024EfgartigimodPost-COVID Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia SyndromeNCT05918978

Phase 3Q3 2024efgartigimod PH20 SCBullous PemphigoidNCT05267600

Phase 3Q4 2024efgartigimod PH20 SCGeneralized Myasthenia GravisNCT04818671

Phase 2Q1 2025EfgartigimodPrimary Sjögren's SyndromeNCT06203457

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

Primary: MG-ADL Total Score Change From Baseline (Up to 29 days in part A)Enrollment:119/119Sites: 91RANDOMIZED, DOUBLE, TREATMENT

Phase 2Q4 2025ARGX-117Delayed Graft FunctionNCT05907096

Primary: eGFR at 24 weeks posttransplant (Up to 24 weeks)Enrollment:103/103Sites: 45RANDOMIZED, TRIPLE, TREATMENT

Phase 3NegativeQ4 2025Thyroid Eye DiseaseNCT06307613

Phase 3NegativeQ4 2025Thyroid Eye DiseaseNCT06307626

Phase 3Q1 2026Myasthenia Gravis, OcularNCT06558279

Primary: MGII (PRO) ocular score change from baseline to day 29 in part A (Up to 29 days)Enrollment:141/141Sites: 102RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q1 2026efgartigimodPrimary Immune ThrombocytopeniaNCT04225156

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

Primary: Reduction in serum C7 antibody levels (26 weeks)Enrollment:Target 18Sites: 1NA, TREATMENT

Phase 2Q3 2026ARGX-119Amyotrophic Lateral SclerosisNCT06441682

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

Primary: Change from baseline in grip strength (4-week average) in the most affected hand at week 24 (Up to 24 weeks)Enrollment:154/154Sites: 109RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q4 2026efgartigimod PH20 SCPrimary Immune ThrombocytopeniaNCT04812925

Primary: Incidence, frequency, and severity of adverse events (AEs), AEs of special interest (AESIs), and serious AEs (SAEs) (216 weeks)Enrollment:173/173Sites: 83NA, TREATMENT

Phase 2Q4 2026Empasiprubart IVDermatomyositis, MyositisNCT06284954

Primary: Incidence of adverse events (AEs) (Up to 90 weeks)Enrollment:3/3Sites: 28RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q4 2026Efgartigimod AlfaOptic NeuritisNCT06453694

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

Phase 3Jan 6, 2027efgartigimod administrationMyasthaenia GravisNCT06765161

Primary: MG-ADL (a sustained decrease persistent for at least 4 consecutive weeks over the 26 week period)Enrollment:Target 30Sites: 1NA, TREATMENT

Phase 2Q1 2027Systemic Sclerosis (SSc)NCT06655155

Primary: Change from baseline in mRSS at week 24 (Up to 24 weeks)Enrollment:Target 81Sites: 79RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3Q1 2027Efgartigimod IVGeneralized Myasthenia GravisNCT04833894

Primary: Efgartigimod concentrations as input for compartmental, model-driven analysis to determine (age and size dependency of) Clearance (CL) (up to 26 weeks)Enrollment:Target 12Sites: 25NA, TREATMENT

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 3Q3 2027Efgartigimod 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: 22NA, TREATMENT

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

Phase 2Q4 2027Empasiprubart IVACh R-Ab Seropositive Generalized Myasthenia Gravis, Myasthenia Gravis (MG), MG - Myasthenia GravisNCT07673627

Phase 2Q4 2027Antibody-mediated RejectionNCT06503731

Phase 2Q1 2028Empasiprubart IVGuillain-Barré Syndrome (GBS)NCT07821762

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

Phase 3Q2 2028Empasiprubart IVChronic Inflammatory Demyelinating Polyradiculoneuropathy, CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy), CIDPNCT07638566

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

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

Phase 3Q2 2028efgartigimod PH20 SCGraves DiseaseNCT07596849

Phase 2Q3 2028efgartigimod PH20 SCSjogrens Disease, Primary Sjögren's Syndrome Painful Sensory NeuropathiesNCT07760818

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

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

Phase 2Q4 2029ARGX-121Immunoglobulin A Nephropathy (Ig AN)NCT07773727

Phase 2Q3 2030Efgartigimod PH20 (ARGX-113) SCAutoimmune Encephalitis (AE)NCT07583641

Phase 3Q4 2030Adimanebart IVCongenital Myasthenic Syndrome, CMSNCT07746089

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

Cost comparison of intravenous immunoglobulin and subcutaneous efgartigimod in patients with chronic inflammatory demyelinating polyneuropathy.

# Investment Summary: Efgartigimod Cost Analysis in CIDP **Clinical/Commercial Implications:** This health economics analysis compares efgartigimod (argenx's FcRn antagonist) against IV immunoglobulin (IVIg) in chronic inflammatory demyelinating polyneuropathy (CIDP), likely demonstrating cost-effectiveness or total cost of care advantages for the subcutaneous treatment option. If efgartigimod shows favorable economics despite higher drug costs, it could support broader adoption and reimbursement coverage by reducing administration burden, infusion center visits, and indirect costs associated with IVIg—key commercial drivers for market penetration in a disease where IVIg is standard of care. **Why It Matters:** Publication of favorable health economics data strengthens argenx's value proposition to payers and healthcare systems, potentially accelerating formulary placement and expanding the eligible patient

Dec 1, 2026

PubMed

Efgartigimod in the treatment of severe Guillain-Barre syndrome with overlapping autoantibody syndrome: a case report and updated clinical review.

# Efgartigimod Case Report Summary for ARGX Investors **Clinical Finding:** This case report documents efgartigimod's potential efficacy in severe Guillain-Barré syndrome (GBS) with concurrent autoantibody overlap, suggesting the FcRn inhibitor may address treatment-resistant presentations beyond the approved indication. **Investment Relevance:** While case reports have limited evidentiary weight, this adds to the clinical evidence supporting efgartigimod's mechanism in severe neuromuscular autoimmune conditions and could inform discussions around potential label expansions or off-label adoption patterns in severe/refractory GBS—a small but underserved patient population where treatment options are limited. **Note:** Monitor for any formal trials in severe/refractory GBS; single case reports typically do not drive commercial opportunity unless followed by prospective clinical data.

Oct 8, 2026

PubMed

Efficacy and Safety of Double-Filtration Plasmapheresis Versus Efgartigimod in Generalized Myasthenia Gravis: A Single-Center Retrospective Study.

# Investment Summary: ARGX Clinical Comparison Study This retrospective study compares efgartigimod (argenx's approved MG therapeutic) against double-filtration plasmapheresis (DFPP), a standard of care treatment, in generalized myasthenia gravis patients. The findings are material because they directly benchmark efgartigimod's efficacy and safety profile against an established comparator, providing real-world evidence relevant to market positioning and reimbursement discussions. If efgartigimod demonstrates superior or comparable efficacy with better tolerability/convenience versus DFPP, it strengthens the commercial case for market penetration and displacement of plasmapheresis in MG management. **Note:** The 2026 publication date suggests this is a hypothetical article. Actual efficacy comparisons and real-world utilization patterns will be critical to monitoring argenx's MG revenue trajectory and competitive positioning

Oct 1, 2026

PubMed

Maintenance of Minimal Manifestation Status with Individualized-Interval Efgartigimod in Generalized Myasthenia Gravis: Study Protocol for a Single-Arm, Open-Label Clinical Trial.

# Investment Summary: argenx Efgartigimod Maintenance Trial This study evaluates whether efgartigimod can maintain long-term disease control in generalized myasthenia gravis (gMG) patients using individualized dosing intervals rather than fixed schedules, potentially reducing treatment burden and improving patient compliance. Success would expand the addressable patient population beyond acute responders to include maintenance therapy, a commercially valuable recurring revenue stream that could differentiate efgartigimod from competitors in the gMG market. The individualized-interval approach addresses a key real-world clinical question about durability and dosing optimization that regulators and payers increasingly scrutinize for chronic immunotherapy indications.

Sep 24, 2026

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