Core Insights - argenx SE is presenting clinical trial and real-world data for VYVGART and VYVGART Hytrulo at the American Academy of Neurology Annual Meeting in April 2025, highlighting their commitment to improving the lives of patients with severe autoimmune diseases [1][2]. Group 1: Product Efficacy and Safety - VYVGART has demonstrated long-term benefits for patients with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP), achieving minimal symptom expression and rapid symptom reduction with a favorable safety profile [2][4]. - The largest safety data set for FcRn blocking shows a consistent and favorable safety profile for both VYVGART and VYVGART Hytrulo, supporting individualized treatment approaches [4][5]. - New data from the ADAPT-NXT study indicates sustained clinical improvements in gMG through various dosing regimens over 126 weeks, reinforcing the long-term safety and efficacy of VYVGART [5]. Group 2: Clinical Presentations and Studies - Presentations at the AAN will include interim results from the ADHERE+ study, which supports the long-term efficacy and safety of VYVGART Hytrulo in CIDP [3][5]. - The Phase 4 open-label trial is investigating the transition from intravenous immunoglobulin (IVIg) to VYVGART Hytrulo, aiming to establish effective and safe treatment protocols [5][7]. - The program will feature multiple oral and poster presentations detailing the design and results of various studies related to VYVGART and its applications in treating gMG and CIDP [3][6]. Group 3: Company Overview and Commitment - argenx is dedicated to advancing immunology through innovative antibody-based medicines, focusing on severe autoimmune diseases and collaborating with leading academic researchers [29]. - The company has developed the first approved neonatal Fc receptor (FcRn) blocker, VYVGART, which is now being evaluated for its potential in multiple serious autoimmune diseases [29][24].

argenx SE (NASDAQ:ARGX) Q4 2024 Earnings Conference Call February 27, 2025 8:30 AM ET Company Participants Beth DelGiacco - Vice President, Corporate Communications and Investor Relations Tim Van Hauwermeiren - Chief Executive Officer Karl Gubitz - Chief Financial Officer Karen Massey - Chief Operating Officer Conference Call Participants Tazeen Ahmad - Bank of America Alex Thompson - Stifel Derek Archila - Wells Fargo Yaron Werber - TD Cowen Victor Floch - BNP Paribas Rajan Sharma - Goldman Sachs Suzanne v ...

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$737 million in fourth quarter and $2.2 billion in full year global product net sales Received positive CHMP recommendation for VYVGART pre-filled syringe for gMG, enabling launch in the EU; FDA PDUFA (gMG and CIDP) on track for April 10 10 Phase 3 and 10 Phase 2 studies across pipeline ongoing in 2025, positioning for next wave of growth Recognized one-time tax benefit of $725 million related to previously unrecognized deferred tax assets Management to host conference call today at 2:30 PM CET (8:30 AM E ...

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, which is available in multiple regions including the U.S., Japan, Israel, the EU, the UK, China, and Canada [3] - argenx is actively evaluating its drug efgartigimod in various serious autoimmune diseases and is advancing several earlier-stage experimental medicines within its therapeutic franchises [3] Upcoming Events - Tim Van Hauwermeiren, the Chief Executive Officer of argenx, will present at the TD Cowen 45 Annual Healthcare Conference on March 3, 2025, at 11:50 a.m. ET [1] - A live webcast of the presentation will be accessible on the Investors section of the argenx website, with a replay available for approximately 30 days post-presentation [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, which is available in multiple regions including the U.S., Japan, Israel, the EU, the UK, China, and Canada [3] - argenx is actively evaluating its drug efgartigimod for multiple serious autoimmune diseases and is advancing several earlier-stage experimental medicines [3] Upcoming Events - argenx will host a conference call and audio webcast on February 27, 2025, at 2:30 PM CET (8:30 AM ET) to discuss its full year 2024 financial results and provide a fourth quarter business update [1] - The live call can be accessed via the Investors section of the argenx website, and a replay will be available for approximately one year [2] Contact Information - Media inquiries can be directed to Ben Petok via email [4] - Investor relations contacts include Alexandra Roy for the US and Lynn Elton for the EU [4]

Core Viewpoint - Argenx SE (ARGX) shows a significant improvement in earnings outlook, making it an attractive investment option as analysts continue to raise earnings estimates [1][2] Current-Quarter Estimate Revisions - The earnings estimate for the current quarter is $1.50 per share, reflecting a year-over-year increase of +189.29% [4] - Over the last 30 days, the Zacks Consensus Estimate for Argenx has risen by 10.98%, with four estimates moving higher and no negative revisions [4] Current-Year Estimate Revisions - For the full year, the earnings estimate stands at $2.51 per share, indicating a change of +148.64% from the previous year [5] - The consensus estimate has increased by 12.71% over the past month, with three estimates moving higher and no negative revisions [5] Favorable Zacks Rank - Argenx has achieved a Zacks Rank 2 (Buy) due to positive estimate revisions, which is a reliable indicator for investors [6] - Research indicates that stocks with Zacks Rank 1 (Strong Buy) and 2 (Buy) tend to significantly outperform the S&P 500 [6] Bottom Line - The stock has gained 5.4% over the past four weeks, driven by solid estimate revisions, suggesting potential for further growth [7]

Financial Performance - Reported preliminary full-year 2024 global product net sales of $2.2 billion, including $737 million in Q4 sales [1] - As of December 31, 2024, the company had approximately $3.4 billion in cash, cash equivalents, and current financial assets [16] - Expected combined R&D and SG&A expenses in 2025 to be approximately $2.5 billion [18] Strategic Priorities for 2025 - Expand the global VYVGART opportunity by reaching more patients across MG, CIDP, and ITP through additional regulatory approvals and evidence generation [3] - Launch VYVGART SC as a pre-filled syringe to innovate the patient experience and move earlier in the MG and CIDP treatment paradigms [3] - Execute 10 registrational and 10 proof-of-concept studies to fuel pipeline growth across efgartigimod, empasiprubart, and ARGX-119 [3][4] - Advance four new molecules into Phase 1 development, expanding the next wave of innovation [3] Pipeline Development - Efgartigimod is being evaluated in over 15 severe autoimmune diseases, with development discontinued in bullous pemphigoid (BP) based on Phase 2 BALLAD study results [5][9] - Empasiprubart is being evaluated in registrational studies for MMN and CIDP, and proof-of-concept studies in DGF and DM [6][19] - ARGX-119 is being evaluated in CMS, ALS, and SMA, with SMA nominated as a third indication [14][19] - Four new pipeline molecules (ARGX-213, ARGX-121, ARGX-109, ARGX-220) nominated, with IND applications to be filed in 2025 [15] Regulatory and Clinical Milestones - FDA PDUFA target action date for pre-filled syringe approval set for April 10, 2025 [1][13] - Regulatory decisions on VYVGART for gMG expected in Israel (SC), South Korea (IV), and Kuwait (IV) in H1 2025 [13] - Topline results expected for multiple studies, including ALKIVIA (H2 2026), UplighTED (H2 2026), UNITY (2027), and Phase 4 switch study in CIDP [5][13] - Auto-injector development underway with a planned launch in 2027 [13] Vision 2030 - Aim to treat 50,000 patients globally with its medicines by 2030 [11] - Secure 10 labeled indications across all approved medicines by 2030 [11] - Advance five pipeline candidates into Phase 3 development by 2030 [11] Innovation and Investment - Continued investment in the Immunology Innovation Program (IIP) to drive long-term sustainable pipeline growth [8][15] - Focus on first-in-class, antibody-based medicines with pipeline-in-a-product potential [8] - Innovation playbook applied to bring transformational outcomes to more patients by unleashing the next wave of autoimmune indications and therapies [7]

Core Insights - argenx is a global immunology company focused on improving the lives of individuals suffering from severe autoimmune diseases [3] - The CEO, Tim Van Hauwermeiren, will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025 [1] - A live webcast of the presentation will be available on the argenx website, with a replay accessible for approximately 30 days [2] Company Overview - argenx partners with leading academic researchers through its Immunology Innovation Program (IIP) to translate immunology breakthroughs into novel antibody-based medicines [3] - The company has developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker globally, with approvals in the U.S., Japan, Israel, the EU, the UK, China, and Canada [3] - argenx is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier-stage experimental medicines within its therapeutic franchises [3]

VYVDURA® now approved for at-home self-injection in Japan for both generalized myasthenia gravis and CIDP argenx's VYVGART® and VYVDURA portfolio approved in Japan for three indications – first country globally with access across three indications December 27, 2024, 7:00 AM 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 Japan's Ministry of Health ...