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 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

Phase 2Q4 2025ARGX-117Delayed Graft FunctionNCT05907096

Phase 3NegativeQ4 2025Thyroid Eye DiseaseNCT06307613

Phase 3NegativeQ4 2025Thyroid Eye DiseaseNCT06307626

Phase 3Q1 2026Myasthenia Gravis, OcularNCT06558279

Phase 3Q1 2026efgartigimodPrimary Immune ThrombocytopeniaNCT04225156

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

Phase 2Q3 2026ARGX-119Amyotrophic Lateral SclerosisNCT06441682

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

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 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 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 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 PH20 SCGraves' Disease, Graves DiseaseNCT07570316

Phase 3Q2 2028efgartigimod PH20 SCGraves DiseaseNCT07596849

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

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

Phase 2Q4 2030Efgartigimod PH20 (ARGX-113) SCAutoimmune Encephalitis (AE)NCT07583641

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

Efgartigimod as a Steroid-sparing Therapy for Evans Syndrome: A Case Report.

# Argenx Investment Summary Efgartigimod demonstrates potential as a steroid-sparing agent in Evans syndrome (autoimmune hemolytic anemia with thrombocytopenia), a rare condition with limited treatment options where most patients require chronic corticosteroids with significant side effects. This case report expands the clinical evidence supporting efgartigimod's mechanism in FcRn-mediated autoimmune disorders and could strengthen the label expansion strategy beyond IgG-mediated indications, though additional controlled data would be needed to establish efficacy and commercial viability in this patient population. Success in Evans syndrome would represent a meaningful market opportunity given the chronic steroid-dependent patient base and lack of approved alternatives, potentially supporting revenue diversification beyond current approved indications.

Jun 11, 2026

PubMed

Efgartigimod as adjunctive therapy in refractory autoimmune glial fibrillary acidic protein astrocytopathy: a case series.

# Investment Summary: Efgartigimod in GFAP+ Astrocytopathy Argenx's efgartigimod demonstrated clinical benefit as add-on therapy in a small case series of patients with refractory GFAP-associated autoimmune astrocytopathy, a rare CNS inflammatory disorder. This represents a potential label expansion beyond the drug's approved indications (myasthenia gravis, IgG4-related disease) into a severe, difficult-to-treat neurological space with limited competitive options. The finding is preliminary given the case series format, but suggests efgartigimod's neonatal Fc receptor (FcRn) inhibition mechanism may address pathogenic IgG-mediated CNS autoimmunity beyond current approved applications, potentially opening a new revenue stream if clinical development progresses.

Jun 10, 2026

PubMed

Pathogenic properties of myasthenia gravis AChR autoantibodies associate with clinical response to efgartigimod.

# Summary for ARGX Investors This study identifies biomarkers—specifically pathogenic properties of AChR autoantibodies—that correlate with clinical response to efgartigimod in myasthenia gravis patients, potentially enabling patient stratification and improving trial design or real-world outcomes prediction. The findings could support label expansion claims, inform patient selection strategies, and reduce heterogeneity in efficacy assessments, strengthening the commercial case for the drug beyond current indications. For investors, this represents data supporting deeper market penetration and potentially higher response rates in selected populations, though clinical utility in routine practice remains dependent on whether such biomarker testing becomes standard-of-care screening.

Jun 4, 2026

PubMed

Clinical effectiveness of efgartigimod in a broad population of patients with generalized myasthenia gravis: subgroup analyses from a randomized, double‑blind, placebo‑controlled, phase 3 trial (ADAPT).

# Efgartigimod (ADAPT Trial) - Investment Summary **Clinical Finding:** Subgroup analyses from the Phase 3 ADAPT trial demonstrate that efgartigimod maintains consistent efficacy across diverse patient populations with generalized myasthenia gravis (gMG), including variations in disease severity, prior treatment history, and demographic factors. **Commercial Implication:** The broad effectiveness across subgroups supports a larger addressable market for efgartigimod beyond narrow patient segments, strengthening commercial viability and reducing market penetration risk post-launch; however, the durability of response and comparative positioning versus existing treatments (including other FcRn inhibitors) remain key determinants of peak sales potential. **Investor Note:** This data reinforces efgartigimod's label expansion opportunity and market differentiation, but actual revenue impact will depend on payer adoption, pricing, and real-world uptake relative to emerging

Jun 3, 2026

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