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argenx SE — Investor Relations & Filings

Ticker · 1AE ISIN · NL0010832176 LEI · 7245009C5FZE6G9ODQ71 BR Manufacturing
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Filings indexed 667 across all filing types
Latest filing 2024-07-16 Regulatory Filings
Country NL Netherlands
Listing BR 1AE

About argenx SE

https://www.argenx.com/?allow=1

argenx SE is a global immunology company that develops and commercializes antibody-based therapies for severe autoimmune diseases. Its lead product, efgartigimod, is a neonatal Fc receptor (FcRn) antagonist designed to reduce pathogenic Immunoglobulin G (IgG) antibodies. Efgartigimod is marketed as VYVGART and VYVGART Hytrulo for approved indications including generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). The company is investigating efgartigimod for several other autoimmune conditions. Its pipeline also includes other first-in-class candidates, such as empasiprubart, a C2 inhibitor for IgM-driven autoimmune diseases. argenx operates an antibody innovation platform, collaborating with academic partners to translate immunology research into therapeutic candidates.

Recent filings

Filing Released Lang Actions
FORM 6-K
Regulatory Filings
2024-07-16 English
argenx and Zai Lab Announce Approval of Efgartigimod Alfa Injection (Subcutaneous Injection) for Generalized Myasthenia Gravis in China
Regulatory Filings Classification · 100% confidence The document is a press release dated July 16, 2024, announcing that China's National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous injection) for generalized myasthenia gravis (gMG). This type of announcement, detailing a significant regulatory approval and providing clinical context, is characteristic of an Earnings Release (ER) or a general press release regarding business milestones. Since it is a formal announcement of a major business/regulatory event rather than a comprehensive financial report (like 10-K or IR) or a transcript, the most fitting category is Earnings Release (ER), as these often include major operational news alongside financial highlights, or Regulatory Filings (RNS) if it were less specific. Given the content focuses heavily on the approval and its implications, ER is a strong fit for a major operational update, though RNS is also plausible as a general announcement. However, ER is often used for significant product/approval news releases. Since it is not a full financial report, and it is a specific announcement, I will classify it as an Earnings Release (ER) as it functions as a major operational update press release, which often overlaps with ER content structure, or RNS as a fallback. Given the context of major drug approval news, ER is often the intended bucket for such high-impact operational news releases, even if no quarterly numbers are present. I will lean towards RNS as the most neutral category for a specific regulatory approval press release that isn't explicitly an earnings report, but since ER often covers major operational milestones, I will select ER as it is a significant event announcement. Re-evaluating: This is a press release announcing a regulatory approval, which is a key corporate event. It is not a quarterly/annual report, nor a transcript. It fits best as an Earnings Release (ER) if we consider 'Earnings Release' to encompass major operational/product news releases, or RNS as a general regulatory announcement. Given the structure and focus on a specific product milestone, ER is often used for these announcements. I will choose ER.
2024-07-16 English
argenx Highlights Breadth of Autoimmune Pipeline with New Multifocal Motor Neuropathy Data at 2024 Peripheral Nerve Society Annual Meeting
Earnings Release Classification · 95% confidence The document is a press release dated June 25, 2024, announcing new data from clinical studies (ARDA and ADHERE+) for two drug candidates (empasiprubart and VYVGART Hytrulo) presented at the 2024 Peripheral Nerve Society Annual Meeting. It details clinical results, trial designs, and safety information. This content structure—announcing clinical data presentation and providing detailed drug/trial information—is characteristic of an Earnings Release (ER) or a general press release summarizing recent scientific/clinical progress, often issued around earnings periods or major medical conferences. Since it focuses on summarizing key results and updates rather than being a full, comprehensive financial report (10-K/IR) or a transcript (CT), the most fitting category is Earnings Release (ER), as these announcements often accompany or precede quarterly financial reporting to highlight operational/pipeline progress. It is not a formal regulatory filing like a 10-K, nor is it a short announcement of a report (RPA/RNS). Q2 2024
2024-06-26 English
FORM 6-K
Regulatory Filings
2024-06-25 English
FORM 6-K
Regulatory Filings
2024-06-24 English
argenx Announces FDA Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy
Regulatory Filings Classification · 100% confidence The document is a press release titled "argenx Announces FDA Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy." It details a significant regulatory event (FDA approval), provides clinical trial data (ADHERE study), outlines safety information, and announces a conference call to discuss the news. This structure is characteristic of an Earnings Release (ER) or a major corporate announcement that is not a full periodic report (like 10-K or IR). Since it focuses on the immediate announcement of a major event (FDA approval) and includes key financial/operational highlights (the approval itself and the call details), it fits best under the Earnings Release (ER) category, which often encompasses major news releases outside of standard quarterly/annual reporting cycles, especially when a conference call is scheduled to discuss it. It is not a full Annual Report (10-K), an Interim Report (IR), or just a simple announcement of a report being published (RPA).
2024-06-24 English

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