Company Overview - argenx is a global immunology company focused on improving the lives of individuals suffering from severe autoimmune diseases [3] - The company is known for developing and commercializing the first approved neonatal Fc receptor (FcRn) blocker, with ongoing evaluations for its potential in various serious autoimmune diseases [3] Upcoming Events - argenx will host a conference call and audio webcast on May 8, 2025, at 2:30 p.m. CET (8:30 a.m. ET) to discuss its first quarter 2025 financial results and provide a business update [1] - A live webcast of the call will be accessible on the Investors section of the argenx website, with a replay available for approximately one year [2] Contact Information - Media inquiries can be directed to Ben Petok via email at bpetok@argenx.com [4] - Investor relations can be contacted through Alexandra Roy at aroy@argenx.com [4]

Core Viewpoint - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of VYVGART® (efgartigimod alfa) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in adult patients, marking a significant advancement in treatment options for this rare autoimmune disease [1][4]. Company Overview - argenx SE is a global immunology company focused on developing innovative treatments for severe autoimmune diseases, aiming to address significant unmet medical needs [2][9]. - The company has developed VYVGART, the first targeted IgG Fc-antibody fragment for CIDP, which, if approved, would be the first novel treatment for CIDP in Europe in over 30 years [2][5]. Clinical Trial Insights - The CHMP recommendation is based on positive results from the ADHERE clinical trial, which is the largest study of CIDP patients to date, involving 322 participants [3][5]. - In the ADHERE trial, 66.5% of patients treated with VYVGART showed clinical improvement, with a primary endpoint met demonstrating a 61% reduction in the risk of relapse compared to placebo [3][5]. - The trial also indicated significant functional improvements in various clinical assessment tools, with 99% of participants opting to continue in the open-label extension of the study [3][5]. Market Implications - The CHMP's positive opinion serves as a scientific recommendation for marketing authorization, with the European Commission expected to make a decision within approximately two months [4][5]. - If approved, VYVGART will be available for subcutaneous injection, providing a new treatment option for CIDP patients across all 27 EU member states, as well as Iceland, Norway, and Liechtenstein [4][5]. Disease Context - CIDP is a rare autoimmune disease affecting the peripheral nervous system, leading to symptoms such as fatigue, muscle weakness, and loss of sensation, which can significantly impair daily functioning [7]. - There are an estimated 31,413 individuals living with CIDP in the European Union, highlighting the need for effective treatment options [7].

Core Viewpoint - Argenx SE (ARGX) shows potential for significant upside, with a mean price target of $748.09 indicating a 25.8% increase from its current price of $594.65 [1] Price Targets and Analyst Consensus - The average of 22 short-term price targets ranges from a low of $620 to a high of $1,100, with a standard deviation of $89.83, suggesting variability in analyst estimates [2] - The lowest estimate indicates a 4.3% increase, while the highest suggests an 85% upside, highlighting the range of analyst expectations [2] - A low standard deviation indicates strong agreement among analysts regarding the stock's price movement direction [9] Earnings Estimates and Market Sentiment - Analysts have shown increasing optimism about ARGX's earnings prospects, with a positive trend in earnings estimate revisions correlating with potential stock price increases [11] - Over the last 30 days, the Zacks Consensus Estimate for the current year has increased by 0.9%, with two estimates moving higher and one lower [12] - ARGX holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13]

argenex SE (ARGX) shares rallied 4.4% in the last trading session to close at $606.39. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 4% loss over the past four weeks.The stock rallied as optimism grew over the company’s marketed product, Vyvgart Hytrulo (efgartigimod), which is approved for treating adult patients with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy ...

The U.S. Food and Drug Administration (FDA) on Thursday approved a new option for patients to self-inject Argenx SE’s ARGX Vyvgart Hytrulo with a prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive and adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).Vyvgart Hytrulo prefilled syringe for self-injection is approved as a 20-to-30-second subcutaneous inje ...

April 11, 2025, 10:01 PM CET Amsterdam, the Netherlands – argenx SE ((Euronext &amp, NASDAQ:ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the Annual General Meeting of shareholders will be held at 13:00 CET on Tuesday, May 27, 2025 at the Hilton Amsterdam Schiphol at Schiphol Boulevard 701, 1118 BN Schiphol, the Netherlands.The shareholders and all other persons with meeting rights are invited to attend the Annu ...

Core Viewpoint - The FDA has approved argenx's VYVGART® Hytrulo prefilled syringe for self-injection, providing a new treatment option for adult patients with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) [1][2][3] Group 1: Product Approval and Features - The VYVGART Hytrulo prefilled syringe allows for a 20-to-30-second subcutaneous injection, which can be administered by patients, caregivers, or healthcare professionals [2][3] - This self-injection option is designed to enhance patient independence and flexibility in treatment administration, allowing patients to choose where and when to receive their treatment [2][3][4] - The approval is supported by studies demonstrating the bioequivalence of the prefilled syringe to the vial formulation, along with successful human factors validation studies [3] Group 2: Patient Impact and Community Response - The new self-injection option is expected to improve convenience and reduce the time required for treatment, thereby enhancing disease management for patients with gMG and CIDP [3][5] - The Myasthenia Gravis Foundation of America and the GBS-CIDP Foundation have expressed support for the approval, highlighting its significance in providing effective treatment options that reduce the need for frequent clinic visits [4][5] Group 3: Company Commitment and Support Programs - argenx is committed to innovating the patient experience by providing individualized, safe, and effective therapies, as evidenced by the introduction of the VYVGART Hytrulo prefilled syringe [6] - The company offers a patient support program, My VYVGART® Path, which includes resources for disease education, access support, and financial assistance for eligible patients [6][7] - argenx aims to translate immunology breakthroughs into a portfolio of novel antibody-based medicines, reinforcing its position as a leader in the immunology sector [19]

Core Insights - argenx SE presented 15 abstracts at the 2025 American Academy of Neurology Annual Meeting, showcasing long-term data for VYVGART and VYVGART Hytrulo, demonstrating sustained disease control in generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) with a favorable safety profile [1][2][3] Group 1: VYVGART and VYVGART Hytrulo Efficacy - VYVGART and VYVGART Hytrulo show differentiated efficacy and safety profiles, with long-term studies indicating significant quality of life improvements for gMG and CIDP patients [3][5] - ADAPT-NXT data reveal that 75% of gMG patients achieved sustained efficacy, with over 56.5% experiencing minimal symptom expression during the study [7] - ADHERE+ data demonstrate functional improvements in CIDP patients, with significant increases in disability scores and grip strength at week 36 compared to baseline [5][6] Group 2: Ongoing Studies and Pipeline - argenx is conducting label expansion studies for VYVGART in ocular myasthenia gravis (oMG) and seronegative myasthenia gravis (snMG) to reach a broader patient community [2][16] - First-in-human data for ARGX-119, a new clinical candidate targeting neuromuscular junction disorders, show a favorable safety profile, supporting its further development [2][31] - The company aims to address unmet needs in underserved patient communities through its robust neuromuscular pipeline [9][34] Group 3: Commitment to Patient Outcomes - The data presented at AAN reinforce argenx's commitment to the neuromuscular community and solidify VYVGART as a leading biologic for improving patient outcomes [3][4] - The company emphasizes individualized treatment options for gMG patients, showcasing the flexibility of VYVGART dosing schedules [6][7] - Real-world data from the ADHERE Phase 4 study indicate a low rate of CIDP worsening among patients transitioning from IVIg to VYVGART Hytrulo [8]

| Table of Contents | | --- | | UNITED STATES | | SECURITIES AND EXCHANGE COMMISSION | | WASHINGTON, D.C. 20549 FORM 20-F | | (Mark One) | | ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES | | EXCHANGE ACT OF 1934 | | OR | | ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE | | ACT OF 1934 | | For the fiscal year ended December 31, 2024 | | OR | | ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES | | EXCHANGE ACT OF 1934 | | For the tr ...

argenex SE (ARGX) shares ended the last trading session 4.1% higher at $604.96. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 10.8% loss over the past four weeks.The stock rallied as optimism grew over the company’s marketed product, Vyvgart Hytrulo (efgartigimod), which is approved for treating adult patients with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). T ...