ARGENX SE (ARGX)

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.

Sector: Biological Products, (No Diagnostic Substances)

Industry: Biotechnology

argenx SE

NASDAQ:ARGXHealthcare · Biotechnology

Mkt Cap$56.15B

Float59.12M

Shares O/S62.89M

Inst Own45.0%

Dilution

-0.55%$892.87

AH$893.30+0.05%vs close

Mkt Cap$56.15B

Float59.12M

O/S62.89M

Vol

$ Vol

RVOL

Inst Own45.0%

Earnings

Dilution

NASDAQ:ARGX$892.87-0.55%

MCap$56.15B

Float59.12M

O/S62.89M

Inst Own45.0%

Dilution

Upcoming Catalysts

empasiprubartREADOUT
Dec 2026~8w8-K
VYVGART HytruloSUBMISSIONsBLA PLANNED
Year-end 2026~8w8-K
VYVGARTPDUFA
pediatric generalized myasthenia gravis
Feb 2027~16w8-K

Phase Distribution

87 lead-sponsored trials·38 active·35 completed

Phase 119

Phase 225

Phase 2/37

Phase 326

Phase 42

Not applicable8

(13 more as collaborator)

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials

Sponsor role

Status

Phase

Phase 4
Completed
A Study to Assess Adults With CIDP Transitioning From IVIg to Efgartigimod PH20 SC
Efgartigimod PH20 SC
Chronic Inflammatory Demyelinating Polyneuropathy
Enrollment
23
Start
Dec 2024
Primary Completion
Feb 2026
Completion
Feb 2026
NCT06637072
Phase 4
Recruiting
A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
Efgartigimod PH20 SC
New Onset Generalized Myasthenia Gravis (gMG)
Enrollment
30
Start
Apr 2025
Primary Completion
Aug 2026est.
Completion
May 2027est.
NCT06909214
Phase 3
Completed
An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
ARGX-113, Placebo
Generalized Myasthenia Gravis
Enrollment
167
Start
Aug 2018
Primary Completion
Apr 2020
Completion
Apr 2020
NCT03669588
Phase 3
Completed
A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.
ARGX-113
Generalized Myasthenia Gravis
Enrollment
151
Start
Mar 2019
Primary Completion
Jun 2022
Completion
Jun 2022
NCT03770403
Phase 3
Completed
A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).
efgartigimod
Primary Immune Thrombocytopenia
Enrollment
131
Start
Dec 2019
Primary Completion
Feb 2022
Completion
Feb 2022
NCT04188379
Phase 3
Completed
A Long-term Study to Assess the Safety and Efficacy of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).
efgartigimod
Primary Immune Thrombocytopenia
Enrollment
101
Start
Jun 2020
Primary Completion
Mar 2026
Completion
Mar 2026
NCT04225156
Phase 3
Withdrawn
A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP)
efgartigimod
Primary Immune Thrombocytopenia (ITP)
Enrollment
0
Start
Jun 2020
Primary Completion
Sep 2021est.
Completion
Sep 2021est.
NCT04274452
Phase 3
Completed
A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)
efgartigimod PH20 SC, prednisone
Pemphigus Vulgaris, Pemphigus Foliaceus
Enrollment
222
Start
Dec 2020
Primary Completion
Aug 2023
Completion
Aug 2023
NCT04598451
Phase 3
Terminated
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)
efgartigimod PH20 SC, prednisone
Pemphigus Vulgaris, Pemphigus Foliaceus
Enrollment
183
Start
Jul 2021
Primary Completion
Mar 2024
Completion
Mar 2024
NCT04598477
Phase 3
Completed
A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
Efgartigimod PH20 SC
Primary Immune Thrombocytopenia
Enrollment
207
Start
Dec 2020
Primary Completion
Oct 2023
Completion
Oct 2023
NCT04687072
Phase 3
Completed
Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis
efgartigimod PH20 SC, efgartigimod IV
Generalized Myasthenia Gravis
Enrollment
110
Start
Feb 2021
Primary Completion
Nov 2021
Completion
Dec 2021
NCT04735432
Phase 3
Active, not recruiting
A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
efgartigimod PH20 SC
Primary Immune Thrombocytopenia
Enrollment
173
Start
Nov 2021
Primary Completion
Oct 2027est.
Completion
Oct 2027est.
NCT04812925
Phase 3
Completed
Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis
efgartigimod PH20 SC
Generalized Myasthenia Gravis
Enrollment
184
Start
Apr 2021
Primary Completion
Dec 2024
Completion
Dec 2024
NCT04818671
Phase 3
Completed
An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis
Efgartigimod IV
Generalized Myasthenia Gravis, MG - Myasthenia Gravis +1
Enrollment
69
Start
Dec 2021
Primary Completion
Aug 2023
Completion
Oct 2025
NCT04980495
Phase 3
Terminated
A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid
efgartigimod PH20 SC, Prednisone
Bullous Pemphigoid
Enrollment
64
Start
Mar 2023
Primary Completion
Mar 2025
Completion
Mar 2025
NCT05681481
Phase 3
Enrolling by invitation
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy
Efgartigimod PH20 SC
Myositis, Active Idiopathic Inflammatory Myopathy +4
Enrollment
240
Start
Sep 2023
Primary Completion
Sep 2028est.
Completion
Sep 2028est.
NCT05979441
Phase 3
Active, not recruiting
A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
Efgartigimod IV
Generalized Myasthenia Gravis, gMG +2
Enrollment
119
Start
Apr 2024
Primary Completion
Jun 2025
Completion
Jun 2028est.
NCT06298552
Phase 3
Terminated
A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease
Efgartigimod PH20 SC, Placebo PH20 SC
Thyroid Eye Disease
Enrollment
102
Start
Mar 2024
Primary Completion
Dec 2025
Completion
Feb 2026
NCT06307613
Phase 3
Terminated
A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease.
Efgartigimod PH20 SC, Placebo PH20 SC
Thyroid Eye Disease
Enrollment
105
Start
Mar 2024
Primary Completion
Dec 2025
Completion
Feb 2026
NCT06307626
Phase 3
Recruiting
A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia
Efgartigimod IV
Primary Immune Thrombocytopenia (ITP)
Enrollment
69
Start
Oct 2024
Primary Completion
Jun 2028est.
Completion
Jun 2028est.
NCT06544499
Phase 3
Active, not recruiting
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis
Efgartigimod PH20 SC, Placebo PH20 SC
Myasthenia Gravis, Ocular
Enrollment
141
Start
Sep 2024
Primary Completion
Jan 2026
Completion
Dec 2027est.
NCT06558279
Phase 3
Active, not recruiting
A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome
Efgartigimod PH20 SC
Primary Sjogrens Disease
Enrollment
631
Start
Jan 2025
Primary Completion
Jul 2027est.
Completion
Jul 2028est.
NCT06684847
Phase 3
Active, not recruiting
A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy
Empasiprubart, IVIG (Intravenous Immunoglobulin)
Multifocal Motor Neuropathy (MMN), MMN
Enrollment
154
Start
Dec 2024
Primary Completion
Sep 2026est.
Completion
Dec 2029est.
NCT06742190
Phase 3
Recruiting
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
empasiprubart, IVIg
Chronic Inflammatory Demyelinating Polyneuropathy, CIDP +1
Enrollment
218
Start
Aug 2025
Primary Completion
Sep 2027est.
Completion
Sep 2030est.
NCT06920004
Phase 3
Recruiting
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
Empasiprubart IV
Chronic Inflammatory Demyelinating Polyneuropathy, CIDP +1
Enrollment
160
Start
Sep 2025
Primary Completion
Oct 2027est.
Completion
Jan 2031est.
NCT07091630

		Drug / Therapy	Title	Conditions	Enrollment				Link
Phase 4	Completed	Efgartigimod PH20 SC	A Study to Assess Adults With CIDP Transitioning From IVIg to Efgartigimod PH20 SC	Chronic Inflammatory Demyelinating Polyneuropathy	23	Dec 2024	Feb 2026	Feb 2026	NCT06637072
Phase 4	Recruiting	Efgartigimod PH20 SC	A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)	New Onset Generalized Myasthenia Gravis (gMG)	30	Apr 2025	Aug 2026est.	May 2027est.	NCT06909214
Phase 3	Completed	ARGX-113, Placebo	An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness	Generalized Myasthenia Gravis	167	Aug 2018	Apr 2020	Apr 2020	NCT03669588
Phase 3	Completed	ARGX-113	A Safety and Tolerability Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness.	Generalized Myasthenia Gravis	151	Mar 2019	Jun 2022	Jun 2022	NCT03770403
Phase 3	Completed	efgartigimod	A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).	Primary Immune Thrombocytopenia	131	Dec 2019	Feb 2022	Feb 2022	NCT04188379
Phase 3	Completed	efgartigimod	A Long-term Study to Assess the Safety and Efficacy of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).	Primary Immune Thrombocytopenia	101	Jun 2020	Mar 2026	Mar 2026	NCT04225156
Phase 3	Withdrawn	efgartigimod	A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP)	Primary Immune Thrombocytopenia (ITP)	0	Jun 2020	Sep 2021est.	Sep 2021est.	NCT04274452
Phase 3	Completed	efgartigimod PH20 SC, prednisone	A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)	Pemphigus Vulgaris, Pemphigus Foliaceus	222	Dec 2020	Aug 2023	Aug 2023	NCT04598451
Phase 3	Terminated	efgartigimod PH20 SC, prednisone	A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)	Pemphigus Vulgaris, Pemphigus Foliaceus	183	Jul 2021	Mar 2024	Mar 2024	NCT04598477
Phase 3	Completed	Efgartigimod PH20 SC	A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia	Primary Immune Thrombocytopenia	207	Dec 2020	Oct 2023	Oct 2023	NCT04687072
Phase 3	Completed	efgartigimod PH20 SC, efgartigimod IV	Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis	Generalized Myasthenia Gravis	110	Feb 2021	Nov 2021	Dec 2021	NCT04735432
Phase 3	Active, not recruiting	efgartigimod PH20 SC	A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia	Primary Immune Thrombocytopenia	173	Nov 2021	Oct 2027est.	Oct 2027est.	NCT04812925
Phase 3	Completed	efgartigimod PH20 SC	Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis	Generalized Myasthenia Gravis	184	Apr 2021	Dec 2024	Dec 2024	NCT04818671
Phase 3	Completed	Efgartigimod IV	An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis	Generalized Myasthenia Gravis, MG - Myasthenia Gravis	69	Dec 2021	Aug 2023	Oct 2025	NCT04980495
Phase 3	Terminated	efgartigimod PH20 SC, Prednisone	A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid	Bullous Pemphigoid	64	Mar 2023	Mar 2025	Mar 2025	NCT05681481
Phase 3	Enrolling by invitation	Efgartigimod PH20 SC	A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy	Myositis, Active Idiopathic Inflammatory Myopathy	240	Sep 2023	Sep 2028est.	Sep 2028est.	NCT05979441
Phase 3	Active, not recruiting	Efgartigimod IV	A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis	Generalized Myasthenia Gravis, gMG	119	Apr 2024	Jun 2025	Jun 2028est.	NCT06298552
Phase 3	Terminated	Efgartigimod PH20 SC, Placebo PH20 SC	A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease	Thyroid Eye Disease	102	Mar 2024	Dec 2025	Feb 2026	NCT06307613
Phase 3	Terminated	Efgartigimod PH20 SC, Placebo PH20 SC	A Study of Efgartigimod PH20 SC Given by Prefilled Syringe in Adults With Thyroid Eye Disease.	Thyroid Eye Disease	105	Mar 2024	Dec 2025	Feb 2026	NCT06307626
Phase 3	Recruiting	Efgartigimod IV	A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia	Primary Immune Thrombocytopenia (ITP)	69	Oct 2024	Jun 2028est.	Jun 2028est.	NCT06544499
Phase 3	Active, not recruiting	Efgartigimod PH20 SC, Placebo PH20 SC	A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis	Myasthenia Gravis, Ocular	141	Sep 2024	Jan 2026	Dec 2027est.	NCT06558279
Phase 3	Active, not recruiting	Efgartigimod PH20 SC	A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome	Primary Sjogrens Disease	631	Jan 2025	Jul 2027est.	Jul 2028est.	NCT06684847
Phase 3	Active, not recruiting	Empasiprubart, IVIG (Intravenous Immunoglobulin)	A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy	Multifocal Motor Neuropathy (MMN), MMN	154	Dec 2024	Sep 2026est.	Dec 2029est.	NCT06742190
Phase 3	Recruiting	empasiprubart, IVIg	A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP	Chronic Inflammatory Demyelinating Polyneuropathy, CIDP	218	Aug 2025	Sep 2027est.	Sep 2030est.	NCT06920004
Phase 3	Recruiting	Empasiprubart IV	A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP	Chronic Inflammatory Demyelinating Polyneuropathy, CIDP	160	Sep 2025	Oct 2027est.	Jan 2031est.	NCT07091630

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