argenx Target Price for 2026 | Analyst Rating & Price

argenx

ENXTBR:ARGX

€ 771,00

€-21,20 (-2,68%)

771,00 €

€-21,20 (-2,68%)

End-of-day quote: 12/05/2025

argenx Stock Value

According to analysts, the current valuation of argenx is Outperform.

Outperform

argenx Company Info

EPS Growth 5Y

21,80%

Market Cap

€47,19 B

Long-Term Debt

€0,00 B

Annual earnings

02/26/2026

Dividend

€0,00

Dividend Yield

0,00%

Founded

2008

Industry

Health Care

Country

Netherlands

Website

argenx

ISIN Number

NL0010832176

Website

http://www.argenx.com

Analyst Price Target

€805,00

4.41%

Last Update: 12/06/2025

Analysts: 13

Highest Price Target €900,00

Average Price Target €805,00

Lowest Price Target €480,00

In the last five quarters, argenx’s Price Target has risen from €364,14 to €649,96 - a 78,49% increase. Eleven analysts predict that argenx’s share price will increase in the coming year, reaching €805,00. This would represent an increase of 4,41%.

Top growth stocks in the health care sector (5Y.)

What does argenx do?

argenx SE (argenx) operates as a commercial-stage, global, fully integrated biopharma company. The company is developing a deep pipeline of differentiated therapies for the treatment of severe autoimmune diseases. By combining its suite of antibody engineering technologies with the disease biology expertise of the company’s research collaborators, it intends to translate immunology breakthroughs into a pipeline of novel antibody-based medicines through its discovery engine, the IIP. The company...

argenx SE (argenx) operates as a commercial-stage, global, fully integrated biopharma company.

The company is developing a deep pipeline of differentiated therapies for the treatment of severe autoimmune diseases. By combining its suite of antibody engineering technologies with the disease biology expertise of the company’s research collaborators, it intends to translate immunology breakthroughs into a pipeline of novel antibody-based medicines through its discovery engine, the IIP. The company developed and is commercializing the first approved FcRn blocker in more than 30 countries, and it is evaluating efgartigimod in multiple serious autoimmune diseases. The company is also advancing its second asset, empasiprubart, a C2 inhibitor, which is in Phase 3. Several earlier stage experimental medicines, including ARGX-119, a MuSK agonist, are in its first patient proof-of-concept studies.

Reach More Patients Globally with VYVGART

VYVGART is approved in the U.S., Japan, the EU, the U.K., Switzerland, Israel, Mainland China, Canada, South Korea, the United Arab Emirates, Australia, and Kuwait (through Genpharm Services FZ-LLC (Genpharm)) for the treatment of gMG. VYVGART is also approved and launched in Japan for the treatment of ITP. VYVGART SC is approved in the U.S., the EU, the U.K., Japan, China (through Zai Lab), Australia, and Kuwait (through Genpharm) for the treatment of gMG and in the U.S., Japan, and China for the treatment of CIDP.

The company filed for the approval of VYVGART for gMG in Saudi Arabia and is expecting a decision on approval in 2025. The company also filed for approval of VYVGART SC for CIDP in the EU, and is expected decision on approval in 2025. It received approval of the PFS for gMG in Europe on February 13, 2025. The company filed for approval of the PFS for gMG and CIDP in the U.S., with a PDUFA Date of April 10, 2025. The company also filed for approval in Canada and Japan, with expected decisions on approval in 2025.

Advance Extensive Pipeline

The company continues to demonstrate breadth and depth within its immunology pipeline and has advanced multiple pipeline-in-a-product candidates. With efgartigimod, the company is furthering its leadership in neonatal Fc receptor (FcRn) and it is continuing its development in more than 10 indications today. Beyond efgartigimod, the company is advancing its other clinical pipeline programs, including empasiprubart (C2 inhibitor), which has shown proof-of-concept in MMN, initiated its first Phase 3 clinical trial, and is in Phase 2 POC clinical trials in delayed graft function (DGF) and DM. The company also announced CIDP as the 4th indication for empasiprubart during its R&D Day on July 16, 2024, and plans to start a registrational study in CIDP evaluating empasiprubart head-to-head versus intravenous IgG (IVIg) in the first half of 2025.

In addition, the company has initiated Phase 1b/2a clinical trials of ARGX-119, a MuSK agonist, in CMS congenital myasthenic syndromes and ALS. Four new pipeline candidates were nominated in 2024 from its immunology innovation program (IIP), including ARGX-213, ARGX-121, ARGX-220, and ARGX-109. Phase 1 results are expected for ARGX-109 in the second half of 2025, and for ARGX-213 and ARGX-121 in the first half of 2026.

Build out the Innovation Ecosystem

In January 2024, the company announced the nomination of four new pipeline candidates, including: ARGX-213 targeting FcRn, furthering argenx’s leadership in this new class of medicine; ARGX-121 targeting Immunoglobulin A (IgA) and ARGX-220, which are first-in-class targets broadening argenx’s focus across the immune system; and ARGX-109, targeting IL-6, which plays an important role in inflammation. Preclinical work is ongoing in each candidate and the first healthy volunteer studies are expected to start in 2025.

Medicines

VYVGART is a first-in-class antibody fragment targeting FcRn. VYVGART is the only gMG treatment available as both an IV and a simple SC injection (VYVGART SC).

VYVGART is approved in more than 30 countries and VYVGART SC is approved in the U.S., the EU, the U.K., Japan, Israel, China, and in Australia for the treatment of gMG. VYVGART SC is also approved in the U.S., China, and Japan (as VYVDURA) for the treatment of CIDP. VYVDURA is also approved for the treatment of ITP in Japan.

Pipeline

efgartigimod is an IgG1 antibody Fc fragment that has been engineered for increased affinity to FcRn compared to endogenous IgG. efgartigimod selectively reduces IgG by blocking FcRn-mediated IgG recycling without impacting antibody production or affecting other parts of the immune system. It is approved in three indications, including gMG, CIDP, and ITP; and is being evaluated in more than 10 additional serious autoimmune indications.

empasiprubart (C2 inhibitor): empasiprubart is a novel complement inhibitor targeting C2, blocking the function of both the classical and lectin pathways while leaving the alternative pathway intact.

ARGX-119 (MusK agonist): ARGX-119 is an agonist SIMPLE ANTIBODY to the MuSK receptor with potential in multiple neuromuscular indications. It is in proof-of-concept studies for CMS (Phase 1b clinical trial), ALS (Phase 2a) and will start in SMA in 2025.

Preclinical Candidates: Four INDs to start Phase 1 studies in 2025:

ARGX-213, targets FcRn, furthering argenx’s leadership in this new class of medicine.

ARGX-121 targeting IgA and ARGX-220 both broadening argenx’s focus across the immune system.

ARGX-109, targets IL-6, which plays an important role in inflammation.

In addition to its wholly-owned pipeline, the company has candidates that emerged from its IIP that it out-licensed to a partner for further development and for which it has milestone, royalty or profit-share agreements. These candidates include, amongst others: cusatuzumab (anti-CD70 antibody – OncoVerity), ARGX-112 (LP-0145 – anti-IL-22R antibody – LEO Pharma), ARGX-114 (AGMB-101 – agonistic anti-MET antibody – Agomab) and ARGX-115 (ABBV-151 – anti-GARP antibody – AbbVie).

Immunology Innovation Program (IIP)

The company's IIP is central to its core business strategy of co-creation and innovation. The IIP also serves as its discovery engine to identify novel targets, and together in collaboration with its scientific and academic partners, to build potential new pipeline candidates. Every current pipeline candidate from both its wholly owned and partnered pipeline emerged from an IIP collaboration. The IIP enables the company to build its broad pipeline of products and product candidates and advance its long-term strategy to be a sustainable, integrated immunology company.

IIP programs include:

efgartigimod emerged from a collaboration with Professor Sally Ward at the University of Texas Southwestern Medical Center and later became one of the blueprints for the company’s IIP collaborations. Professor Ward’s research identified the crucial role that FcRn plays in maintaining and distributing IgGs throughout the body. efgartigimod is a human IgG1 Fc fragment that is equipped with ABDEG mutations, which it in-licensed from the University of Texas Southwestern Medical Center. These proprietary mutations modified efgartigimod to increase its affinity for FcRn while retaining the pH-dependent binding that is characteristic of FcRn interactions with its natural ligand, endogenous IgG.

empasiprubart was built in collaboration with Broteio Pharma B.V. (Broteio). Broteio was launched in 2017 with support from Professor Erik Hack and the University of Utrecht, to conduct research demonstrating preclinical POC of the mechanism of action of empasiprubart. Professor Hack is a renowned researcher in the role of inflammation in disease, specifically in the complement system, and has contributed research and expertise to the approval of two complement inhibitors. His understanding of the mild phenotype associated with a natural C2 deficiency and C2’s unique positioning at the junction of the classical and lectin pathways led to its interest in engineering empasiprubart with the company’s proprietary NHANCE mutations and LALA mutations.

ARGX-119 was built in collaboration with the Leiden University Medical Center (LUMC) and New York University (NYU) with support from teams led by Professor Verschuuren and Professor Steve Burden, respectively. Both groups have world-class expertise in unraveling the biological mechanism of neuromuscular disease and translating these insights from the lab to the patient.

The company brings to the collaboration its unique suite of antibody discovery and antibody engineering technologies, and experience in clinical development, to complement its partners’ expertise in disease and target biology. The company's suite of technologies includes, among others, its SIMPLE ANTIBODY platform technology, NHANCE, ABDEG, POTELLIGENT, and DHS mutations, which focus on engineering the Fc region of antibodies in order to augment their intrinsic therapeutic properties.

Suite of Technologies

Through the company’s IIP, it collaborates with scientific and academic partners to identify immunology breakthroughs and build potential pipeline candidates. This is done through co-creation. The company brings to the collaboration its unique suite of antibody engineering technologies and experience in clinical development to complement its partners’ expertise in disease and target biology.

SIMPLE ANTIBODY platform technology: The company’s proprietary SIMPLE ANTIBODY platform technology, based on the powerful llama immune system, allows it to exploit novel and complex disease biology targets. The platform sources antibody variable regions (V-regions) from the immune system of outbred llamas, each of which has a different genetic background. The llama produces highly diverse panels of antibodies with a high human homology, or similarity, in their V-regions when immunized with targets of human disease. The company’s SIMPLE ANTIBODY platform technology allows the company to access and explore a broad target universe while potentially minimizing the long timelines associated with generating antibody candidates using traditional methods.

NHANCE, ABDEG, POTELLIGENT, and DHS mutations focus on engineering the Fc region of antibodies in order to augment their intrinsic therapeutic properties. In addition, the company obtained a non-exclusive research license and option from Chugai Pharmaceutical Co., Ltd. (Chugai) for the SMART-Ig (‘Recycling Antibody’ and part of ‘Sweeping Antibody’) and ACT-Ig (Antibody half-life extending) technologies. These technologies are designed to enable the company to expand the therapeutic index of its product candidates, which is the ratio between toxic and therapeutic dose, by potentially modifying their half-life, tissue penetration, rate of disease target clearance, and potency. In 2020, the company also entered into a non-exclusive research agreement with the Clayton Foundation under which it may access the Clayton Foundation’s proprietary DHS mutations to extend the serum half-life of therapeutic antibodies.

Programs

VYVGART

Approvals and Regulatory Plan

The company’s two approved medicines, VYVGART and VYVGART SC, are FcRn blockers. VYVGART is approved in more than 30 countries for the treatment of adults with gMG who are anti-acetylcholine receptor (AChR) antibody positive (AChR-AB+) and for the treatment of adults with gMG who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs), including seronegative patients, in Japan. VYVGART is also approved for the treatment of adult patients with ITP in Japan. The company’s second product, VYVGART SC, is a subcutaneous combination of efgartigimod alfa and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme Therapeutics, Inc.’s (Halozyme) ENHANZE SC drug delivery technology. It has been approved for the treatment of adults with gMG who are AChR-AB+ as VYVGART HYTRULO in the U.S. and China, as VYVGART in the EU, and as VYVGART SC in the U.K., Israel. It has also been approved as VYVDURA in Japan for the treatment of adults with gMG who do not have sufficient response to steroids or non-steroidal ISTs, including seronegative patients. VYVGART SC has also been approved for the treatment of adults with CIDP in the U.S. and China as VYVGART HYTRULO and in Japan as VYVDURA.

More approvals and launches of both VYVGART and VYVGART SC in multiple jurisdictions and countries are planned following pricing and reimbursement negotiations.

Commercialization

The company has established its own sales force in the U.S., Japan, Europe, and Canada for VYVGART for the treatment of gMG and CIDP (where approved). It plans to expand its own sales and marketing capabilities and promote its products and product candidates in other regions if it decides there is a business case to do so after regulatory approval has been obtained.

Development and commercialization may also be conducted through collaborations with third parties. In January 2021, the company entered into an exclusive out-license agreement with Zai Lab (Zai Lab Agreement), a commercial-stage biopharmaceutical company, for the development and commercialization of efgartigimod in Greater China (which includes Mainland China, Hong Kong, Taiwan, and Macau, Greater China). Zai Lab announced approval of VYVGART in Mainland China in June 2023 for the treatment of adult gMG patients, and in 2024, Zai Lab also announced the approval of VYVGART SC for gMG and CIDP. Under the Zai Lab Agreement, the company received and continues to be eligible for certain sales-based milestone payments and royalties based on annual product net sales of efgartigimod in Greater China.

In October 2021, the company announced an exclusive distribution agreement with Medison to commercialize efgartigimod for gMG in Israel (Medison Agreement). Medison filed for and obtained approval for VYVGART in April 2023 and for VYVGART SC in September 2024. On June 6, 2022, the company announced an exclusive multi-regional agreement with Medison to commercialize efgartigimod in 14 countries, including Poland, Hungary, Slovenia, the Czech Republic, Romania, Bulgaria, Lithuania, Croatia, Slovakia, Estonia, Latvia, Greece, and Cyprus, for the treatment of adult patients with gMG (Medison Multi-Regional Agreement).

In January 2022, the company entered into a partnership agreement with Genpharm Services FZ-LLC (Genpharm), under which Genpharm shall purchase VYVGART from the company for the resale in the Gulf Cooperation Council (comprising Saudi Arabia, Kuwait, the United Arab Emirates, Qatar, Bahrain, and Oman) on an exclusive basis for Genpharm’s own account and own name (Genpharm Agreement).

In 2023, the company entered into the Handok Agreement for the distribution of VYVGART in South Korea and in 2024 it received approval for VYVGART in South Korea.

The company intends to sign additional distribution partnerships for other territories.

In the U.S., argenx advertises certain products via digital and traditional media channels, including the internet and television.

Pre-Approval Access Program

The company is committed to improving the lives of people suffering from rare diseases. It is driven to discover new treatment approaches, fueled by the resilience of patients to urgently deliver them. The company intends to do this in partnership; it listens to patients, supporters, and advocacy communities, and it hears their stories. Their insights guide the company as it develops its investigational therapies and motivate it to advance the understanding of rare diseases.

The company has a Pre-Approval Access program (PAA) for patients with gMG, which opened on February 21, 2021, for patients who are unable to participate in an ongoing clinical trial. In 2024, it approved access to this PAA for over 403 gMG patients in 14 countries. The PAA program remains open in countries where VYVGART is not yet launched or reimbursed.

efgartigimod (formerly ARGX-113) Development

Mechanism of Action

efgartigimod is a human IgG1 Fc fragment equipped with the company’s ABDEG mutations that is designed to target the FcRn and reduce IgG. FcRn is foundational to the immune system and functions to recycle IgG, extending its serum half-life over other IgGs that are not recycled by FcRn. IgGs that bind to FcRn are rescued from lysosomal degradation. By binding to FcRn, efgartigimod can reduce IgG recycling and increase IgG degradation.

Indication Selection Strategy

The company utilizes the following strategy to select indications for efgartigimod:

The company first starts with a strong, unifying biological rationale. The indications in its pipeline are unified in that there exists a wide range of supportive evidence that demonstrates that each is IgG-mediated. This ranges from published literature, clinical trials with used therapies, such as IVIg, PLEX, or rituximab, and other experiments, such as passive transfer models.

The company also looks at indications where a significant clinical or commercial opportunity exists. These are disease areas where there is a significant unmet need for innovation, as patients are often not well-managed by current therapies and their respective side effects.

Furthermore, for each indication, there is a defined path forward with established precedent for how to run POC and registrational clinical trials with generally accepted clinical and regulatory endpoints.

Formulations

The company is developing two formulations of efgartigimod to address the needs of patients, physicians, and payers across indications and geographies, including efgartigimod IV (VYVGART) and efgartigimod SC (VYVGART SC).

gMG

gMG is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness.

In May 2020, the company announced positive topline results from the pivotal ADAPT clinical trial of efgartigimod for the treatment of gMG. The topline results from the ADAPT clinical trial showed that efgartigimod was well-tolerated, demonstrated clinically meaningful improvements in strength and quality of life measures, and provided the option of an individualized dosing schedule for gMG patients. The full Phase 3 ADAPT results were published in The Lancet Neurology in July 2021. The data from the ADAPT clinical trial and the subsequent OLE (ADAPT+) formed the basis for the regulatory approvals of VYVGART in the U.S., Japan, the EU, Mainland China, Israel, the U.K. and Canada.

On March 22, 2022, the company announced positive topline results from the Phase 3 ADAPT-SC clinical trial, a registrational non-inferiority bridging clinical trial of efgartigimod SC for the treatment of gMG. efgartigimod SC achieved the primary endpoint of total IgG reduction from baseline at day 29, demonstrating statistical noninferiority to VYVGART IV formulation in gMG patients. Based on these results, it received regulatory approval in the U.S., the EU, China, Japan, Switzerland, the U.K., Israel and Australia.

Other Clinical Trials

In 2024, the company initiated registrational clinical trials to expand the VYVGART label into broader MG populations, including in seronegative gMG patients (ADAPT-SERON) and ocular MG patients (ADAPT-OCULUS). The company also has clinical trials ongoing in pediatric gMG patients (ADAPT-JUNIOR) with efgartigimod IV and efgartigimod SC.

CIDP

In July 2023, the company announced positive topline results from the ADHERE clinical trial evaluating VYVGART SC (efgartigimod alfa and hyaluronidase-qvfc) in adults with CIDP. The clinical trial met its primary endpoint (p=0.000039), demonstrating a significantly lower risk of relapse with VYVGART SC compared to placebo (HR: 0.39 95% CI: 0.25; 0.61). 67% of patients in open-label Stage A demonstrated evidence of clinical improvement, indicating that IgG autoantibodies play a significant role in the underlying biology of CIDP.

VYVGART SC was well-tolerated with a safety profile that is consistent with prior clinical trials and the known profile of VYVGART. The most frequent treatment-related adverse event was ISRs, which occurred in a lower percentage of patients than previous VYVGART SC clinical trials (20% in Stage A; 10% in Stage B). All ISRs were mild to moderate and resolved over time. 99% (226/249) of eligible patients continued to the ADHERE-Plus OLE clinical trial.

Based on these results, the company received regulatory approval in the U.S. in June 2024, in China in November 2024 and in Japan in December 2024. Regulatory review is ongoing in other jurisdictions, including in the EU.

Primary ITP

Phase 3 ADVANCE Clinical Trials

In 2019, the first of two registrational clinical trials, the ADVANCE clinical trial, was initiated to evaluate efgartigimod IV (VYVGART) for the treatment of primary ITP. The second registrational ADVANCE-SC clinical trial of efgartigimod SC for the treatment of primary ITP was initiated in 2020.

In May 2022, the company announced positive Phase 3 data from the ADVANCE clinical trial. Primary endpoint was met, demonstrating that a significantly higher proportion of patients with chronic ITP receiving VYVGART (17/78; 21.8%) compared to placebo (2/40; 5%) achieved a sustained platelet response (p=0.0316), defined as having platelet counts greater than or equal to 50x109/L on at least four of the last six scheduled visits between weeks 19 and 24 of treatment.

VYVGART was well-tolerated in this 24-week clinical trial and the observed safety and tolerability profile was consistent with previous clinical trials.

In November 2023, results of the second registrational clinical trial as part of the ongoing ITP development program for VYVGART in adult patients with chronic and persistent ITP were announced. Patients were heavily pre-treated and 75% of patients had received three or more prior ITP therapies. The clinical trial did not meet the primary endpoint of a sustained platelet count response in chronic ITP patients. Secondary endpoints were also not met, including additional endpoints on International Working Group responder status and mean platelet count change from baseline.

VYVGART SC was well-tolerated in ADVANCE-SC; the observed safety and tolerability profile was consistent with ADVANCE-IV and the confirmed safety profile of VYVGART and VYVGART SC.

Based on the results of the ADVANCE-IV clinical trial the company received regulatory approval for VYVGART for the treatment of adults with ITP in Japan in March 2024. The company has initiated ADVANCE-NEXT in the U.S. with efgartigimod IV in ITP in 2024.

Myositis

The company initiated the registrational ALKIVIA clinical trial of efgartigimod SC for the treatment of Myositis in 2022. The clinical trial will enroll approximately 240 patients in three Myositis subtypes, IMNM, ASyS and DM. The clinical trial is being conducted in two Phases, with an analysis of the Phase 2 portion of the clinical trial, including 30 patients of each subtype, followed by conduct of the Phase 3 portion of the clinical trial only if a signal is observed in the Phase 2 portion of the clinical trial.

In November 2024, argenx announced the company’s GO decision to continue clinical development of efgartigimod SC in the seamless phase2/3 ALKIVIA clinical trial (ongoing) in all three Myositis subtypes following analysis of topline data from the Phase 2 portion of the clinical trial. The decision is supported by the efficacy and safety results from the Phase 2 portion of the seamless Phase 2/3 ALKIVIA clinical trial. Overall, the clinical trial met its primary endpoint, demonstrating a statistically significant treatment effect in mean TIS at Week 24, and showed improvement across all six core set measures of the TIS in the favor of efgartigimod SC compared to placebo. The observed safety and tolerability profile was consistent to that demonstrated with other clinical trials.

TED

The UplighTED program aims to evaluate the efficacy and safety of weekly efgartigimod for SC administration in pre-filled syringe, co-formulated with rHuPH20 (efgartigimod PH20 SC) in two randomized, placebo-controlled, double-blinded studies. Adult participants with moderate-to-severe active TED, with controlled baseline autoimmune thyroid pathology are dosed with 1000mg efgartigimod PH20 SC or placebo PH20 SC for 24 weeks and evaluated for proptosis response. At the end of the treatment period, participants will enter a follow-up observational period to assess safety, tolerability, and durability of efgartigimod PH20 SC treatment while off therapy or an open-label treatment period depending on their response to study treatment.

SjD

Phase 2 RHO Clinical Trial (in partnership with IQVIA)

In March 2024, argenx announced its plan to continue the development of efgartigimod to Phase 3 in adults with primary SjD, following the analysis of topline data from the Phase 2 RHO clinical trial.

The decision to advance the clinical development of efgartigimod in SjD was supported by the safety, efficacy and biomarker results from the clinical trial. The observed safety and tolerability profile was consistent with other clinical trials. Efficacy assessments showed a treatment effect across multiple clinical endpoints, which were also consistent with biomarker data.

In the RHO clinical trial, efgartigimod demonstrated increased response on composite endpoints (CRESS, STAR, ESSDAI (22-34%)). A response was observed in four out of five items of CRESS.

The IgG reduction and biomarker data correlated to clinical benefit and efgartigimod was well tolerated and safe similar to other clinical trials.

Phase 3 UNITY Clinical Trial (in partnership with IQVIA)

In 2024, the company initiated a Phase 3 clinical trial evaluating efgartigimod PH20 SC for the treatment of SjD. The Unity clinical trial is a randomized, placebo-controlled, double-blind clinical trial evaluating safety and efficacy of efgartigimod PH20 SC. The clinical trial plans to enroll 480 patients with at least moderate systemic disease (ClinESSDAI =6). Patients have to be on stable background treatment and positive for anti-SSA/Ro. At the end of the 48-week treatment period, participants who complete the clinical trial may roll over into an OLE. The primary endpoint is change from baseline in the clinESSDAI (Clinical ESSDAI). Key secondary endpoints will focus on patient-reported outcomes, ESSDAI (EULAR Sjögrens Syndrome Disease Activity Index), and STAR (Sjögren's Tool for Assessing Response, composite endpoint).

Phase 2 POC Clinical Trial (in partnership with Zai Lab)

In 2023, the company initiated a POC clinical trial to evaluate the efficacy and safety of efgartigimod IV in Chinese patients with active LN. The clinical trial plans to enroll approximately 60 patients with LN class III or IV (with or without class V).

Other efgartigimod Indications

AMR

AMR is an autoimmune disease that affects transplanted organs and can contribute to allograft loss. AMR in kidney allografts is driven by donor specific antibodies, which often target HLA antigens expressed by endothelial allograft cells. Through different mechanism, donor specific antibodies can induce microvascular inflammation, a histopathological hallmark of AMR. Microvascular inflammation leads to loss in organ function which, if continued, can result in allograft loss. The unmet need for an efficacious treatment is very high, as evidenced by AMR being the leading cause of kidney transplant failure. There are no approved therapies for treating AMR.

Phase 2 shAMRock Clinical Trial Design

n the end of 2024, the company initiated a Phase 2 POC study to evaluate efgartigimod PFS in kidney transplant recipients with AMR. The clinical trial will enroll ~30 participants, randomized 1x1x1 across 2 treatment arms and placebo. Primary endpoint is safety and tolerability and secondary endpoints include efficacy endpoints around estimated glomerular filtration rate, kidney biopsy, urine protein creatinine ratio and survival.

Partnerships for efgartigimod Indications

Zai Lab Limited

Pursuant to the Zai Lab Agreement, Zai Lab obtained the exclusive right to develop and commercialize efgartigimod in Greater China. Zai Lab will also contribute patients to the company’s global Phase 3 clinical trials of efgartigimod. The company’s Zai Lab strategic collaboration allows it to accelerate development of efgartigimod into new autoimmune indications with Zai Lab taking operational leadership of selected Phase 2 POC clinical trials.

In 2022, Zai Lab initiated the Phase 2 POC clinical trials in MN and LN, which both fall within the emerging nephrology indications. Zai Lab also completed a Phase 1 PK/PD clinical trial to support the approval of efgartigimod for gMG in Mainland China and to obtain regulatory approvals to enroll Chinese patient into the company’s global Phase 3 clinical trials.

IQVIA

On December 2, 2021, the company entered into a strategic asset development agreement with IQVIA Ltd (IQVIA). Pursuant to the asset development agreement, IQVIA shall perform asset and indication development services for efgartigimod through an advanced outsourcing model. Such services include, but are not limited to, overall product indication development strategy, design of clinical trial protocol, set-up, execution and management of clinical development plans for an indication for efgartigimod selected by the company.

To enable and encourage fast and innovative delivery of the services by IQVIA, the asset development agreement contains an innovative earn-back and bonus plan based upon the performance of IQVIA.

Clinical trials that have been discontinued:

In May 2024, the decision was made to discontinue planned development of efgartigimod in AAV following the risk assessment of all ongoing clinical trials based on learnings from ADDRESS (PV) and ADVANCE SC (ITP) clinical trials.

In June 2024, the company announced results from the Phase 2 ALPHA clinical trial of efgartigimod in PC-POTS. Based on the results, it decided not to move forward development of efgartigimod in PC-POTS.

In October 2024, the company announced the discontinuation of the development of efgartigimod in MN. This decision was based on the observation that no clear signal was seen in the blinded data, which was part of an interim review by the executive data review team and the data and safety monitoring board.

Early January 2025, the company announced its decision to discontinue development in BP based on results from 98 patients in the Phase 2 BALLAD clinical trial.

empasiprubart (ARGX-117) Development

empasiprubart is a differentiated therapeutic mAb targeting C2 equipped with the company’s proprietary NHANCE mutations. By addressing a novel target at the intersection of the complement and lectin pathways of the complement cascade. Activation of the classical and lectin pathway of complement may contribute to tissue damage and organ dysfunction in a number of autoimmune inflammatory diseases and ischemia-reperfusion conditions. Targeting C2 also leaves the alternative pathway of the complement system intact, which is an important component of the innate defense system.

empasiprubart exhibits both pH- and calcium dependent binding. These unique characteristics enable empasiprubart to capture free C2 in circulation and release it in the endosome to be sorted for degradation in the lysosome. empasiprubart is equipped with NHANCE mutations increasing its affinity for FcRn and allowing it to recycle back into circulation to capture more C2.

In addition to an IV formulation, the company has exclusive access to Halozyme’s ENHANZE SC drug delivery technology for the C2 target.

empasiprubart Indications

MMN

Phase 2 POC ARDA Clinical Trial

The Phase 2 POC ARDA clinical trial was a randomized, double-blinded, placebo-controlled multicenter clinical trial to evaluate the safety and tolerability, efficacy, PK, PD, and immunogenicity of two dose regimens of empasiprubart in adults with MMN. The primary endpoint was safety and tolerability. Additional endpoints included time to IVIg retreatment, biomarker analyses of C2 levels, and changes in measurements on key functional scores (modified medical research council -10 sum score, grip strength, MMN-RODS, as well as several patient-reported quality of life outcome measures (fatigue severity score (FSS), chronic acquired polyneuropathy patient-reported index (CAP-PRI), and values of the patient global impression change scale).

Based on these results argenx initiated the EMPASSION Phase 3 clinical trial evaluating empasiprubart in MMN at the end of 2024.

Phase 3 EMPASSION Clinical Trial Design

A Phase 3, randomized, double-blinded, double-dummy clinical trial evaluating the efficacy and safety of empasiprubart versus intravenous immunoglobulin in adults with multifocal motor neuropathy. The clinical trial comprises a screening period of up to 15 weeks, including a minimum of 2 IVIg cycles; a 24-week (6-month), randomized, double-blinded, double-dummy treatment period (part A) evaluating the efficacy and safety of empasiprubart vs IVIg continuation; a 24-month OLE period (part B); and a 15-month safety follow-up period starting after the last dose of IMP. The primary objective is to demonstrate the efficacy of empasiprubart compared to IVIg in improving functional ability. This will be measured by change from baseline in the 25-item MMN-RODS centile score at week 24. Additional key secondary endpoints include changes in measurements on key functional scores (modified medical research council -14 sum score, grip strength) as well as patient-reported quality of life outcome measures (polyneuropathy patient-reported index, and values of the patient global impression change scale and evaluation of manual dexterity using 9HPT.

DGF

Phase 2 POC VARVARA Clinical Trial

The Phase 2 POC VARVARA clinical trial was initiated in 2023 and is a randomized, placebo-controlled, double-blinded clinical trial to evaluate the efficacy, safety and tolerability of empasiprubart in improving allograft function in recipients at risk for DGF. The clinical trial will include approximately 102 recipients of an at-risk deceased donor kidney. After a short screening period of < 24 hours, patients are randomly assigned in a 1:1 ratio to receive two doses of empasiprubart IV or placebo, of which one dose is administered during transplantation and one a week later. Participants receive standardized background induction and maintenance immunosuppression. They are evaluated for 52 weeks, with one additional safety follow-up visit in week 64. The primary endpoint is the estimated glomerular filtration rate at six months. Key secondary endpoints include DGF risk, safety, and PK, PD and immunogenicity.

Phase 2 POC EMPACIFIC Clinical Trial

The EMPACIFIC clinical trial is a Phase 2 POC, randomized, double-blinded, placebo-controlled, multicenter clinical trial to evaluate the safety, tolerability, and efficacy of multiple dose regimens of IV empasiprubart in adults with DM. A total of 56 adult participants with a clinical diagnosis of DM and active muscle disease will be randomized (1:1:1:1) to one of four treatment arms (three empasiprubart dose regimens and one placebo arm). Participants will receive loading doses on days 1 and 8, followed by maintenance doses every four weeks until the end of the 52-week treatment phase. The primary objective is to evaluate safety and tolerability. The secondary objective is to evaluate clinical efficacy, using the mean TIS at weeks 13, 25, and 52 as endpoint.

CIDP

Phase 3 EMVIGORATE Clinical Trial

In July 2024, the company announced its plan to start a head-to-head Phase 3 development of empasiprubart versus IVIg in CIDP in 1H 2025.

ARGX-119 Development

ARGX-119 is a humanized agonist mAb that specifically targets and activates MuSK to promote maturation and stabilization of the neuromuscular junction (NMJ). The company plans to develop ARGX-119 in a range of neuromuscular diseases, including CMS, a rare hereditary subtype of MG, ALS, and SMA, all severe neuromuscular indications.

ARGX-119 is the first and highly specific agonist mAb targeting human MuSK being developed for patients with neuromuscular disease, such as CMS and ALS. This mAb is derived from llamas and discovered using the argenx SIMPLE ANTIBODY platform technology. The company developed ARGX-119 through its IIP program in collaboration with the world leading key opinion leaders on MuSK and the neuromuscular junction, including Professor Steve Burden from NYU and Professor Verschuuren from LUMC. In collaboration with Professor Burden, it was shown that ARGX-119 holds promising preclinical POC data in Dok7 congenital myasthenic syndrome, observed in a mouse model bearing the most common patient mutation and in ALS using ALS patient derived NMJ on-a-chip models. Based on these data, clinical development for ARGX-119 was initiated as activation of MuSK by ARGX-119 may stabilize, mature, and improve the function of the NMJ in patients with CMS or ALS, significantly reducing weakness and fatigability and improving quality of life.

A Phase 1 dose-escalation clinical trial in healthy volunteers was completed in 2024; data support advancement in POC studies.

A Phase 1b and 2a clinical trial in CMS and ALS respectively initiated in 2024 to assess early signal detection in patients. Early January 2025, the company announced SMA as the third indication for ARGX-119 for which it expects to initiate a POC clinical trial in 2025.

ARGX-213, ARGX-121, ARGX-220 and ARGX-109 Development

The company continues to invest in its discovery engine, the IIP, to drive long-term sustainable pipeline growth. Through the IIP, four new pipeline candidates were nominated in 2023, including: ARGX-213 targeting FcRn and furthering argenx’s leadership in this new class of medicine; ARGX-121 targeting IgA and ARGX-220, which broaden argenx’s focus across the immune system; and ARGX-109, targeting IL-6, which plays an important role in inflammation. Preclinical work is ongoing for each candidate and the company expects Phase 1 results in 2025 and 2026.

Antibody Engineering and Other Technology Capabilities

Proprietary SIMPLE ANTIBODY Platform

The company’s proprietary SIMPLE ANTIBODY platform technology sources V-regions from conventional antibodies existing in the immune system of outbred llamas. Outbred llamas are those that have been bred from genetically diverse parents, and each has a different genetic background. The llama produces highly diverse panels of antibodies with a high human homology in their V-regions when immunized with human disease targets. The company then combines these llama V-regions with Fc regions of fully human antibodies, resulting in antibodies that it then produces in industry-validated production cell lines. The company’s SIMPLE ANTIBODY platform technology allows the company to access and explore a broad target universe, including novel and complex targets, while minimizing the long timelines associated with generating antibody candidates using traditional methods.

Antibody Engineering Technologies

Through licensing, the company has obtained access to a broad range of antibody engineering technologies. NHANCE, ABDEG, POTELLIGENT and the DHS mutations focus on engineering the Fc region of antibodies, while SMART-Ig and ACT-Ig technologies allow to make sweeping antibodies.

Fc engineering can augment antibodies interactions with components of the immune system, thereby potentially expanding the therapeutic index of the company’s product candidates by modifying their half-life, tissue penetration, rate of disease target clearance and potency. For example, the company’s NHANCE and ABDEG engineering technologies enable the company to modulate the interaction of the Fc region with FcRn, which is responsible for regulating half-life, tissue distribution and PD properties of IgG antibodies. Similarly, the POTELLIGENT engineering technology modulates the interaction of the antibody Fc region with receptors located on specialized immune cells known as natural killer (NK) cells. These NK cells can destroy the target cell, resulting in enhanced antibody-dependent cell-mediated cytotoxicity (ADCC).

NHANCE and ABDEG: Modulation of Fc Interaction with FcRn.

Serum proteins, including IgG antibodies, are routinely removed from the circulation by cell uptake. Antibodies can bind to FcRn, which serves as a dedicated recycling receptor in the endosomes, which have an acidic environment, and then return to the circulation by binding with their Fc region to FcRn. Unbound antibodies end up in the lysosomes and are degraded by enzymes. Because this Fc/FcRn interaction is highly pH-dependent, antibodies tightly bind to FcRn at acidic pH (pH 6.0) in the endosomes but release again at neutral pH (pH 7. 4) in the circulation.

NHANCE

NHANCE refers to two mutations that the company introduces into the Fc region of an IgG antibody. NHANCE is designed to extend antibody serum half-life and increase tissue penetration. In certain cases, it is advantageous to engineer antibodies that remain in the circulation longer, allowing them to potentially exert a greater therapeutic effect or be dosed less frequently. NHANCE antibodies bind to FcRn with higher affinity, specifically under acidic pH conditions. Due to these tighter bonds, NHANCE FcRn-mediated antibody recycling is strongly favored over lysosomal degradation, although some degradation does occur. NHANCE allows a greater proportion of antibodies to return to the circulation potentially resulting in increased bioavailability and reduced dosing frequency. ARGX-109, empasiprubart and a number of its discovery-stage programs utilize NHANCE.

ABDEG

ABDEG refers to five mutations that the company introduces in the Fc region that increase its affinity for FcRn at both neutral and acidic pH. In contrast to NHANCE, ABDEG-modified Fc regions remain bound to FcRn if the pH changes, occupying FcRn with such high affinity that they deprive endogenous IgG antibodies of their recycling mechanism, leading to enhanced clearance of such antibodies by the lysosomes. Some diseases mediated by IgG antibodies are directed against self-antigens. These self-directed antibodies are referred to as autoantibodies. The company uses its ABDEG technology to reduce the level of these pathogenic autoantibodies in the circulation by increasing the rate at which they are cleared by the lysosomes. ABDEG is a component in a number of its products and product candidates, including efgartigimod.

The company’s ABDEG technology can also be used with its pH-dependent SIMPLE ANTIBODY generated antibodies in a mechanism referred to as sweeping. Certain antibodies generated through the SIMPLE ANTIBODY platform bind to their target in a pH-dependent manner. These antibodies bind tightly to a target at neutral pH while in circulation, and release the target at acidic pH in the endosome. The unbound target is degraded in the lysosome. However, when equipped with the company’s ABDEG technology, the therapeutic antibodies remain tightly bound to FcRn at all pH levels and are not degraded themselves. Instead, they are returned to the circulation where they can bind new targets.

POTELLIGENT

POTELLIGENT modulates the interaction of the Fc region with the Fc gamma receptor IIIa located on specialized immune cells, known as NK cells. These NK cells can destroy the target cell, resulting in enhanced ADCC. POTELLIGENT changes the Fc structure by excluding a particular sugar unit such that it enables a tighter fit with the Fc gamma receptor IIIa. The strength of this interaction is a key factor in determining the killing potential of NK cells. An independent publication reported that the exclusion of this sugar unit of the Fc region increases the ADCC-mediated cell-killing potential of antibodies by 10- to 1000-fold.

SMART-Ig, ACT-Ig and DHS

In 2020, the company entered into a research license and option agreement with Chugai under which it may access Chugai’s SMART-Ig and ACT-Ig. In 2020, the company also entered into a non-exclusive research agreement with the Clayton Foundation under which it may access the Clayton Foundation’s proprietary DHS mutations to extend the serum half-life of therapeutic antibodies.

SC Drug Delivery Technologies

The company has exclusive access to Halozyme’s ENHANZE SC drug delivery technology for the FcRn and C2 targets and four additional targets. ENHANZE has the potential to shorten drug administration time, reduce healthcare practitioner time, and offer additional flexibility and convenience for patients.

In addition, in April 2021, the company entered into the Elektrofi Agreement with Elektrofi to explore new SC formulations utilizing Elektrofi’s high concentration technology for efgartigimod, and up to one additional target.

Strategy

The key elements of the company’s strategy are to maximize the VYVGART opportunity; maximize the empasiprubart opportunity; build a sustainable, diversified portfolio of breakthrough and differentiated antibody-based products; grow a unique, global biotech company by scaling the argenx way; and ensure long-term sustainability.

Manufacturing and Supply

The company utilizes third-party contract manufacturers who act in accordance with the FDA’s current good manufacturing practices (cGMPs) for the manufacture of drug substance and drug product. The company continues to build its global network of contract manufacturers to support the development and commercialization of its products. The company works with Lonza teams based in Slough, the U.K., Portsmouth, the U.S., Singapore and Visp, Switzerland for activities relating to the development of cell banks, development of its manufacturing processes and the manufacturing of drug substance, thereby using validated and scalable systems broadly accepted in its industry. In 2022, the company started its collaboration with FUJIFILM Diosynth Biotechnologies Denmark ApS (Fujifilm) based in Hillerød, Denmark, for activities relating to the large-scale manufacturing of efgartigimod drug substance. The company uses additional contract manufacturers to fill, label, package, store and distribute (investigational) drug products.

Intellectual Property

The company oversees more than 500 pending applications and granted patents.

The company owns various trademark registrations and applications, and unregistered trademarks, including but not limited to VYVGART, VYVGART HYTRULO, VYVDURA, ARGENX, ABDEG, NHANCE, SIMPLE ANTIBODY, ARGENXMEDHUB, MG UNITED, SHINING THROUGH CIDP and its corporate logo.

Platform Technologies

With regard to its platform technologies, the company owns or has intellectual property rights directed to its SIMPLE ANTIBODY discovery platform, the ABDEG and NHANCE technologies.

With regard to its SIMPLE ANTIBODY discovery platform, the company has a broad patent portfolio providing exclusivity on the SIMPLE ANTIBODY platform. The company expects to enjoy exclusivity under this patent portfolio until between 2029 and 2033.

With regard to the ABDEG platform, the company co-owns the technology with the University of Texas Southwestern Medical Center and enjoy certain exclusive license rights. The company has a broad patent portfolio covering the composition of matter and uses of certain FcRn antagonists to achieve certain biological effects. The composition of matter and other relevant patents in the U.S. expire in 2036 whereas in many other countries the base expiry date is 2034.

With regard to the NHANCE platform, the company exclusively licensed two U.S. patents from the University of Texas Southwestern Medical Center, with the composition of matter claims directed to an IgG molecule comprising a variant human Fc domain, and method of use claims directed to a method of blocking FcRn function in a subject by providing such an IgG molecule to the subject. The U.S. patents are expected to expire earliest in 2027 to 2028. The patent family also includes a granted European patent.

Internal Programs

Efgartigimod

efgartigimod incorporates the ABDEG platform technology. The company anticipates several more patient innovations to evolve during development for which it will seek additional patent protection.

ARGX-109 Product Candidate

With regard to the company’s wholly-owned ARGX-109 product candidate, it has one patent family with composition of matter claims directed to ARGX-109. The patent family has a base expiry date in 2033. The company anticipates several more patient innovations to evolve during development for which it will seek additional patent protection. Furthermore, ARGX-109 incorporates or employs the SIMPLE ANTIBODY platform technology and the NHANCE platform technology.

empasiprubart Product Candidate

With regard to the empasiprubart product candidate, the company owns or has rights to multiple patent families (including one in-licensed patent family from Broteio) with several granted patents and pending patent applications in multiple jurisdictions in North America, South America, the EU and Asia, directed to composition of matter claims and method of treatment claims. The in-licensed patent family from Broteio has granted patents in several countries/regions and has a basic expiry date in 2034. Additional patent families have granted patents with basic expiry dates in 2039 and 2040. The company anticipates several more patient innovations to evolve during development for which it will seek additional patent protection. Empasiprubart product candidate incorporates or employs the NHANCE platform technology.

ARGX-119 Product Candidate

With regard to the ARGX-119 product candidate, the company in-licensed patent families from/with NYU Langone Health, a U.S. medical center based in New York, and additional patent families from/with the LUMC, with a U.S. granted patent and several pending applications in multiple jurisdictions.

ARGX-118 Product Candidate

With regard to the ARGX-118 product candidate, the company co-owns a patent portfolio with VIB vzw (VIB), an inflammation research center in Ghent, Brussels, and Ghent University, with one U.S. granted patent and pending patent applications in multiple jurisdictions in North America, South America, the EU and Asia. The patent family has a basic expiry date in 2039.

Partnered Programs

cusatuzumab (ARGX-110) Product Candidate

With regard to the cusatuzumab product candidate, the company has a broad patent portfolio that include claims to the composition of matter, uses of the molecule, and other important inventions. The issued U.S. patents expire in 2032 and 2033, without taking a potential patent term extension into account. cusatuzumab incorporates or employs the SIMPLE ANTIBODY and POTELLIGENT platform technologies.

ARGX-115 (ABBV-151) Product Candidate

With regard to the ARGX-115 (ABBV-151) product candidate that the company co-owns with, and exclusively licenses from, the Ludwig Institute for Cancer Research and UCL, it has a patent portfolio that includes a U.S. patent with a base expiry date in 2034, without taking a potential patent term extension into account. There is a second family with meaningful patent coverage for the composition of matter and epitope claims that are expected to expire in 2036 and 2038. Furthermore, ARGX-115 (ABBV-151) incorporates or employs the SIMPLE ANTIBODY platform technology.

ARGX-112 (LP-0145) Product Candidate

With regard to the ARGX-112 (LP-0145) product candidate, the company has one patent family with composition of matter claims directed to an antibody that binds human IL-22R. The patent family has a base expiry date in 2037. Furthermore, ARGX-112 (LP-0145) incorporates the SIMPLE ANTIBODY platform technology.

The company has entered into multiple collaboration agreements with pharmaceutical partners and license agreements.

OncoVerity for cusatuzumab

In 2022, the company, the University of Colorado Anschutz Medical Campus and the University of Colorado Health (UCHealth) created an asset-centric spin-off, OncoVerity, Inc (OncoVerity), focused on optimizing and advancing the development of cusatuzumab, a novel anti-CD70 antibody, in acute myeloid leukemia (AML). OncoVerity is an entity of co-creation, combining the extensive translational biology insights from Dr. Clayton Smith, M.D. from the University of Colorado with its experience on the CD70/CD27 pathway.

In 2023, the company granted an exclusive license for cusatuzumab to OncoVerity and provided, together with a joint venture of University of Colorado Health and University License Equity Holdings, Inc. on the University of Colorado Anschutz Medical Campus, and funding for ongoing clinical development of cusatuzumab.

In 2024, the company participated in a further funding round to support the continued, ongoing, clinical development of cusatuzumab by OncoVerity.

Strategic Partnership with LEO Pharma for ARGX-112 (LP0145)

In May 2015, the company entered into a collaboration agreement with LEO Pharma A/S (LEO Pharma) to develop and commercialize ARGX-112 (LP0145) for the treatment of dermatologic indications involving inflammation (LEO Pharma Collaboration Agreement). ARGX-112 (LP0145) employs its SIMPLE ANTIBODY technology and blocks the IL-22R in order to neutralize the signaling of cytokines implicated in autoimmune diseases of the skin. LEO Pharma funded more than half of all product development costs up to clinical trial application (CTA) approval of a first product in a Phase 1 clinical trial, with its shares of such costs capped, which was achieved in April 2018. Since then, LEO Pharma has been solely responsible for funding the clinical development of the program. In May 2021, CTA approval of a Phase 2a clinical trial for LP0145 was received.

In September 2022, LEO Pharma, exercised its option to obtain, and was granted an exclusive, worldwide license to further develop and commercialize ARGX-112. LEO Pharma assumed full responsibility for the continued development, manufacture and commercialization of such product and is subject to diligence obligations in respect of continuation of development and commercialization of such product.

Strategic Partnership with Zai Lab for efgartigimod

Strategic Partnership with AbbVie for ARGX-115 (ABBV-151)

In April 2016, the company entered into a collaboration agreement with AbbVie, Inc. (AbbVie) to develop and commercialize ARGX-115 (ABBV-151) as a cancer immunotherapy against the novel target glycoprotein A repetitions predominant (GARP) (the AbbVie Collaboration Agreement). ARGX-115 (ABBV-151) employs the company SIMPLE ANTIBODY technology and works by stimulating a patient’s immune system after a tumor has suppressed the immune system by co-opting immunosuppressive cells, such as regulatory T cells. Under the terms of the AbbVie Collaboration Agreement, the company is responsible for conducting and funding all ARGX-115 (ABBV-151) research and development activities up to completion of IND enabling studies.

AbbVie has exercised its option and obtained a worldwide, exclusive license to the ARGX-115 (ABBV-151) program to develop and commercialize products and has assumed development obligations, including the sole responsibility for all research, development and regulatory costs relating to ARGX-115 (ABBV-151)-based products.

Pursuant to the AbbVie Collaboration Agreement, the company has the right, on a product-by-product basis, to co-promote ARGX-115 (ABBV-151) based products in the European Economic Area (EEA) and Switzerland and to combine the product with its own future oncology programs (if any).

Exclusive License with Elektrofi for efgartigimod

In April 2021, the company entered into the Elektrofi Agreement with Elektrofi to explore new SC formulations utilizing Elektrofi’s high concentration technology for efgartigimod, and up to one additional target. The Elektrofi-enabled formulations are aimed to promote additional optionality for patients through at-home and self-administration capabilities.

Collaboration with Genmab

In 2023, the company entered into a collaboration with Genmab to jointly discover, develop and commercialize novel therapeutic antibodies with applications in immunology, as well as in oncology therapeutic areas.

Non-Exclusive Research License and Option Agreement with Chugai for SMART-Ig and ACT-Ig

In September 2020, the company entered into a non-exclusive research license and option agreement with Chugai, allowing it to access Chugai’s SMART-Ig and ACT-Ig engineering technologies for conducting feasibility clinical trials. These technologies are designed to enable the company to make sweeping antibodies and expand the therapeutic index of its product candidates, which is the ratio between toxic and therapeutic dose, by potentially modifying their half-life, tissue penetration, rate of disease target clearance and potency.

Non-exclusive License with the Clayton Foundation for DHS mutations

In October 2020, the company entered into a non-exclusive research agreement with the Clayton Foundation relating to the non-exclusive in-license for Clayton Foundation’s proprietary DHS mutations to extend the serum half-life of therapeutic candidates.

Exclusive License with Halozyme for ENHANZE

In February 2019, the company entered into an in-license agreement with Halozyme for the use of certain patents, materials and know-how owned by Halozyme and relating to its ENHANZE, for application in the field of prevention and treatment of human diseases (the ENHANZE License Agreement). Pursuant to the ENHANZE License Agreement, the company was granted exclusive rights to apply ENHANZE to biologic products against pre-specified targets, in order to research, develop and commercialize SC formulations of its therapeutic antibody-based product candidates.

The company’s first therapeutic target for which it received an exclusive license from Halozyme was FcRn, which allows it to apply ENHANZE to efgartigimod and any other product candidates selective and specific for FcRn. Moreover, the breadth of the company’s exclusive license to FcRn precludes either Halozyme itself or any of its current or future partners from utilizing ENHANZE in the context of an FcRn-targeted product. The company’s second therapeutic target for which it received an exclusive license from Halozyme was human C2 associated with the product candidate empasiprubart, which is being developed to treat severe autoimmune diseases. Pursuant to the ENHANZE License Agreement, it also has the right to nominate future targets for an exclusive ENHANZE license if the target in question has not already been licensed by Halozyme or is not already being pursued by Halozyme.

In October 2020, the company expanded its collaboration with Halozyme for ENHANZE drug delivery technology to include three additional exclusive targets upon nomination bringing the total to six potential targets. From the effective date of the ENHANZE License Agreement, the company has a seven-year period in which to conduct research and preclinical trials on other target-specific molecules in combination with ENHANZE.

In September 2024, the company expanded the existing global collaboration and license agreement with Halozyme by nominating four additional targets for a total of six, including FcRn and C2.

The royalty rate for all products under the agreement is a tiered low-to-mid-single digit rate based on target and annual net sales until expiration of Halozyme's ENHANZE related patents, when the rate will be reduced in one or more steps. Royalties will be paid for the longer of 10 years from the first commercial sale or until the expiration of the last valid claim of a co-formulation patent.

Pursuant to the ENHANZE License Agreement, the company has the right to grant sublicenses to its subsidiaries and to third parties both for research/preclinical work (for example, to subcontractors) and for development and commercialization. Halozyme provides dedicated specialist support to the company which it has accrued over 10 years of licensing ENHANZE to its collaborators.

The company has diligence obligations with respect to the continuation of development and commercialization of product candidates, but it is not obligated to utilize ENHANZE for every product candidate directed to a given exclusive target(s).

Exclusive License with Agomab for ARGX-114 (AGMB-101)

In March 2019, the company entered into an exclusive out-license with Agomab for the use of certain patent rights relating to the company’s proprietary suite of technologies for the development and commercialization of a series of agonistic anti-MET SIMPLE ANTIBODY generated antibodies, including ARGX-114 (AGMB-101), a halofuginone-mimetic antibody directed against the MET receptor.

Exclusive License with Broteio for empasiprubart

In March 2017, the company entered into a collaboration with Broteio in connection with its IIP, to develop an antibody against a novel target in the complement cascade, empasiprubart (Broteio Agreement). Under the Broteio Agreement, the company has jointly developed the complement-targeted antibody and established preclinical POC using its proprietary suite of technologies. Upon successful completion of these preclinical studies, the company exercised an exclusive option to in-license the program in March 2018 and assumed responsibility for further development and commercialization.

Exclusive License with VIB for ARGX-118

In November 2016, the company entered into a collaboration under its IIP with VIB vzw (VIB) to develop antibodies against Galectin-10, the protein of Charcot-Ley-den Crystals, which play a major role in severe asthma and the persistence of mucus plugs, including ARGX-118 (VIB Agreement). Pursuant to the VIB Agreement, the company is jointly developing antibodies against Galectin-10 using its proprietary suite of technologies. Upon successful completion of this initial research, the company exercised an exclusive option to in-license the program and assumed responsibility for further development and commercialization.

Exclusive License with the University of Texas for NHANCE and ABDEG

In February 2012, the company entered into an exclusive in-license with the Board of Regents of the University of Texas System (UT BoR) for the use of certain patent rights relating to the NHANCE platform for any use worldwide (the UT Agreement). The UT Agreement was amended on December 23, 2014 to also include certain additional patent rights relating to the ABDEG platform.

Non-Exclusive License with BioWa and Non-Exclusive Commercial Licenses with BioWa and Lonza for POTELLIGENT

In October 2010, the company entered into a non-exclusive license agreement with BioWa, Inc. (BioWa) for the use of certain patents and know-how owned by BioWa and relating to its POTELLIGENT platform technology, for use in the field of prevention and treatment of human diseases. Pursuant to the BioWa Agreement, the company is granted a non-exclusive right to use POTELLIGENT to research and develop antibodies and products containing such antibodies using POTELLIGENT.

In 2013 and 2014, the company entered into non-exclusive license agreements for POTELLIGENT CHOK1SV with BioWa and Lonza for the further development, manufacturing and commercialization of ARGX-110 and ARGX-111, respectively (the POTELLIGENT License Agreements).

Upon commercialization of the company’s products developed using POTELLIGENT, it will be obligated to pay BioWa and Lonza a percentage of net sales of a licensed product as a royalty. This royalty varies with net sales volume, ranging in the low single digits, and it is reduced by half if during the following 10 years from the first commercial sale of the product in a country the last valid claim within the licensed patent(s) that covers the product expires or ends.

non-exclusive license with Lonza for Multi-product GS Xceed-License

On February 4, 2015, the company entered into a non-exclusive multi-product in-license agreement with Lonza (the Multi-Product License) for use of Lonza’s proprietary glutamine synthetase gene expression system known as GS Xceed consisting of Chinese hamster ovary cell line and the vectors for the manufacturing of drug substance (the System). The System is used for the manufacturing of, amongst others, efgartigimod, empasiprubart and ARGX-119.

Pursuant to the Multi-Product License, the company has the right to grant sublicenses to certain pre-approved third parties without prior written consent of Lonza, but otherwise it must obtain Lonza’s prior written consent.

Collaboration with Universite Catholique de Louvain (UCL) and Sopartec S.A. (Sopartec) for GARP

In January 2013, the company entered into a collaboration and exclusive product license agreement with UCL and its technology transfer company Sopartec to discover and develop novel human therapeutic antibodies against GARP (GARP Agreement).

In January 2015, the company exercised the option it was granted under the GARP Agreement to enter into an exclusive, worldwide commercial in-license for use of certain GARP-related intellectual property rights owned by UCL and the Ludwig Institute for Cancer Research to further develop and commercialize licensed products, including the GARP-neutralizing antibody ARGX-115 which was discovered under the original collaboration (GARP License).

Exclusive Licenses with NYU Langone Health and LUMC for ARGX-119

In 2019 and 2020, the company entered into collaboration and exclusive license agreements with NYU Langone Health and LUMC, respectively, under its IIP to develop antibodies targeting the MuSK, for the treatment neuromuscular diseases, which play a major role at the neuromuscular junction (NYU and LUMC Agreements). Pursuant to the NYU and LUMC Agreements, the company, NYU and LUMC jointly developed antibodies against MuSK using its proprietary suite of technologies.

Research and Development

The company’s research and development expenses totaled $983 million for the year ended December 31, 2024.

History

argenx SE was founded in 2008. The company was incorporated under the laws of the Netherlands in 2008.

argenx Questions and Answers

Which sectors generate sales and which are the top 3 markets?

Pharmaceutical Sales: 100% (2025) TOP 3 Markets: USA: 60% Europe: 25% Asia: 10% argenx SE is a biopharmaceutical company that focuses on the development of therapies for autoimmune diseases and cancer. The majority of sales come from the pharmaceutical industry, particularly through the sale of dr...

At which locations are the company’s products manufactured?

Production Sites: Mainly in the Netherlands and Belgium (estimated 2025) argenx SE is a biopharmaceutical company that focuses on the development of therapeutics. The production of their products mainly takes place in the Netherlands and Belgium, where they have specialized facilities and partnershi...

What strategy does argenx pursue for future growth?

Research and Development: 40% of the budget (2025) Market Expansion: Targeted expansion in the US and Asian markets (2025) argenx SE pursues a growth strategy that heavily focuses on research and development (R&D). The company invests around 40% of its budget in R&D to develop new innovative...

Which raw materials are imported and from which countries?

Main raw materials: Biotechnological materials, laboratory chemicals Countries of origin: USA, Germany, China argenx SE is a biopharmaceutical company specializing in the development of antibody therapies. For the production and development of their products, the company mainly imports biotechnologi...

How strong is the company’s competitive advantage?

Market share: Estimated at 10% in the field of autoimmune diseases (2025) Research and development investments: 25% of revenue (2024) Patent portfolio: Over 50 active patents (2025) argenx SE has gained a significant competitive advantage through its specialization in novel antibody therapies. The c...

What is the share of institutional investors and insider buying/selling?

Institutional Investor Share: 85% (estimated for 2025 based on trends until 2023) Insider Buys/Sells: No specific current data available for 2025. Historically, there were no significant insider transactions in 2023. The institutional investor share in argenx SE has traditionally been high, indicati...

What percentage market share does argenx have?

Market share of argenx SE: Estimate 3-5% (2025) Main competitors and their market shares: Roche Holding AG: 15% Novartis AG: 14% Johnson & Johnson: 12% Pfizer Inc.: 10% Sanofi: 9% AstraZeneca: 8% Merck & Co., Inc.: 7% GlaxoSmithKline plc: 6% Amgen Inc.: 5% argenx SE: 3-5% Moat of argenx SE...

Is argenx stock currently a good investment?

Revenue growth: 30% (2024) Research and development expenditure: 40% of revenue (2024) Pipeline progress: Several Phase III studies successfully completed (2024) argenx SE recorded an impressive revenue growth of 30% in 2024, attributed to the successful commercialization of their innovative therapi...

Does argenx pay a dividend – and how reliable is the payout?

Dividend: No payout (as of 2025) argenx SE has not paid any dividends in the past and continues this practice in 2025. The company reinvests its profits in research and development to further expand its pipeline of drugs and drive innovations. The reliability of dividend payments is therefore not re...

argenx Stock Value

argenx Company Info

Analyst Price Target

Top growth stocks in the health care sector (5Y.)

What does argenx do?

argenx Questions and Answers

Offer & Services

Service & Collaboration

Company & Legal