ALKIVIA data demonstrate significant improvement in muscle strength and physical function in myositis patients treated with efgartigimodRHO data show efgartigimod achieved sustained reduction in autoantibodies and improved functional outcomes in patients with Sjogren’s disease; program granted U.S. FDA Fast Track designationargenx committed to new therapeutic areas in rheumatology with ongoing Phase 3 studies in myositis (ALKIVIA) and Sjogren’s disease (UNITY) June 11, 2025, 12:01 AM CET Amsterdam, the Net ...

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 of its potential across multiple serious autoimmune diseases [3] Upcoming Event - Karl Gubitz, the Chief Financial Officer of argenx, will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference on June 10, 2025, at 8:40 AM ET in Miami, FL [1] - A live webcast of the presentation will be available on the Investors section of the argenx website, with a replay accessible for approximately 30 days following the event [2]

Core Viewpoint - Argenx SE (ARGX) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in buying or selling pressure that affects stock prices [4]. Recent Performance and Projections - Argenx is projected to earn $13.02 per share for the fiscal year ending December 2025, reflecting a year-over-year increase of 406.6% [8]. - Over the past three months, the Zacks Consensus Estimate for Argenx has risen by 20%, indicating a positive trend in earnings expectations [8]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating [9][10]. - The upgrade of Argenx to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

$790 million in first quarter global product net sales First patients treated with VYVGART Hytrulo pre-filled syringe for self-injection in US and Germany CIDP global expansion with positive CHMP opinion for VYVGART-SC (vial and pre-filled syringe) in EU Management to host conference call today at 2:30 PM CET (8:30 AM ET) May 8, 2025, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe ...

Company Overview - argenx is a global immunology company focused on improving the lives of individuals suffering from severe autoimmune diseases [3] - The company collaborates with leading academic researchers through its Immunology Innovation Program (IIP) to translate immunology breakthroughs into a portfolio of novel antibody-based medicines [3] - argenx has developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker, evaluating its potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines [3] Upcoming Event - Tim Van Hauwermeiren, the Chief Executive Officer of argenx, along with members of the management team, will present at the BofA Securities 2025 Health Care Conference on May 13, 2025, at 4:20 p.m. PT [1] - A live webcast of the presentation will be available on the Investors section of the argenx website, with a replay accessible for approximately 30 days following the event [2]

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]

Company Overview - Argenx SE (ARGX) shares increased by 4.4% to close at $606.39, following a notable trading volume, contrasting with a 4% loss over the past four weeks [1] - The stock's rally is linked to growing optimism regarding its marketed product, Vyvgart Hytrulo (efgartigimod), which is approved for treating adult patients with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) [2] Product Developments - The FDA has recently approved a new self-injection option for Vyvgart Hytrulo using a prefilled syringe for the aforementioned indications [2] - Argenx is also exploring the use of efgartigimod in various serious autoimmune diseases [2] Financial Performance Expectations - The company is projected to report quarterly earnings of $2.20 per share, reflecting a year-over-year increase of 311.5% [3] - Expected revenues are $790.36 million, which is a 91.6% increase compared to the same quarter last year [3] Earnings Estimate Revisions - The consensus EPS estimate for Argenx has been revised 1.6% higher in the last 30 days, indicating a positive trend that typically correlates with stock price appreciation [4] - The stock currently holds a Zacks Rank of 3 (Hold) [4] Industry Context - Argenx is part of the Zacks Medical - Biomedical and Genetics industry, where another company, Viridian Therapeutics, Inc. (VRDN), saw a 10.7% increase in its stock price, closing at $13.30, despite a -24.5% return over the past month [4] - Viridian Therapeutics has an unchanged consensus EPS estimate of -$0.95, representing a -20.3% change from the previous year [5]

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 ...