argenx(ARGX)

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argenx Announces Annual General Meeting of Shareholders on May 27, 2025
Newsfilter· 2025-04-11 20:01
Core Points - The Annual General Meeting of shareholders for argenx SE is scheduled for May 27, 2025, at 13:00 CET in Amsterdam [1] - The formal notice of the meeting, including details on attendance and e-voting, is available on the argenx website [2] - The company's annual report for the financial year ending December 31, 2024, is now accessible on its investor relations page [3] Agenda Items - The agenda includes the discussion and adoption of the 2024 annual accounts, an advisory vote on the 2024 remuneration report, discharge of directors for their 2024 duties, and authorization for the Board to issue shares [4] - It is proposed to re-appoint Anthony Rosenberg as a non-executive director and to adopt a new remuneration policy [4] Company Overview - argenx is a global immunology company focused on severe autoimmune diseases, partnering with academic researchers to develop novel antibody-based medicines [6] - The company has developed the first approved neonatal Fc receptor (FcRn) blocker and is exploring its potential in various serious autoimmune diseases [6]
argenx Announces FDA Approval of VYVGART Hytrulo Prefilled Syringe for Self-Injection in Generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy
Globenewswire· 2025-04-10 21:47
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]
argenx Highlights VYVGART Data at AAN 2025 Setting New Standard in Sustained Efficacy and Improved Quality of Life Measures for Patients Living with gMG and CIDP
Newsfilter· 2025-04-08 05:00
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]
argenx(ARGX) - 2024 Q4 - Annual Report
2025-03-20 10:46
| 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 ...
argenx(ARGX) - 2024 Q4 - Annual Report
2025-03-20 10:07
Annual Report 2024 Annual Report 2024 2024 Annual Report including the Annual Financial Statements for the year ended December 31, 2024 This Annual Report is filed with the Dutch Authority for the Financial Markets (Stichting Autoriteit Financiële Markten, AFM). The following main items included in our annual report on Form 20-F for the year ended December 31, 2024 (2024 20-F) filed with the United States Securities and Exchange Commission (SEC) on or about the date of this Annual Report have not been inclu ...
Argenx (ARGX) Surges 4.1%: Is This an Indication of Further Gains?
ZACKS· 2025-03-17 14:35
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 ...
argenx Highlights FcRn Leadership with Long-term Data and Transformational Patient Outcomes at the American Academy of Neurology 2025 Annual Meeting
Newsfilter· 2025-03-07 06:00
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(ARGX) - 2024 Q4 - Earnings Call Transcript
2025-02-27 20:17
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 ...
argenx: Vyvgart's Sales Momentum Improves, Clinical Data Updates From A Key Competitor Imminent
Seeking Alpha· 2025-02-27 16:58
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argenx Reports Full Year 2024 Financial Results and Provides Fourth Quarter Business Update
Newsfilter· 2025-02-27 06:00
$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 ...