argenx

argenx SE operates as a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. It operates from the Netherlands, Belgium, the United States of America, Japan, Switzerland, Germany and France. The firm partnering with academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. It evaluates efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. The company was founded by Hans J. W. de Haard, Torsten Dreier, and Tim van Hauwermeiren in 2008 and is headquartered in Breda, the Netherlands.

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argenx SE is a global immunology company, which engages in improving the lives of people suffering from severe autoimmune diseases. It operates through the following geographical segments: United States, Japan, EMEA, and China. The company was founded by Hans J. W. de Haard, Torsten Dreier, and Tim van Hauwermeiren in 2008 and is headquartered in Amsterdam, the Netherlands.

$374 million in fourth quarter and $1.2 billion in full year global net product sales sBLA for VYVGART® Hytrulo for CIDP accepted for priority review by FDA with PDUFA target action date of June 21, 2024 On track to report data from six Phase 2 proof-of-concept trials by end of 2024 Management to host conference call today at 2:30 pm CET (8:30 am ET) February 29, 2024, 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 autoimmune diseases, today reported financial results for the full year 2023 and provided a fourth quarter business update. “argenx reached thousands of new patients and their families in 2023 by delivering on our commitment to make VYVGART available to the global MG community,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

argenx Reports Full Year 2023 Financial Results and Provides Fourth Quarter Business Update

February 22, 2024 Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that it will host a conference call and audio webcast on Thursday, February 29, 2024 at 2:30 PM CET (8:30 AM ET) to discuss its full year 2023 financial results and provide a fourth quarter business update.

argenx to Report Full Year 2023 Financial Results and Fourth Quarter Business Update on February 29, 2024

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Prescription Drug User Fee Act (PDUFA) target action date is June 21, 2024 If approved, VYVGART ® Hytrulo will be the first neonatal Fc receptor (FcRn) blocker to treat CIDP February 20, 2024, 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 autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP). The application has been granted a PDUFA target action date of June 21, 2024.

argenx Announces FDA Acceptance of Supplemental Biologics License Application with Priority Review for VYVGART Hytrulo in Chronic Inflammatory Demyelinating Polyneuropathy

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Vyvgart generated $1.2 billion in net sales in 2023 and is in a good position to continue performing well in 2024 and beyond. Empasiprubart has generated strong results in the first cohort of MMN patients, putting this candidate on investors' radars and offering something other than Vyvgart. Pipeline expansion includes ARGX-213, the next-generation Vyvgart, which could address some of Vyvgart's limitations and extend the patent life of the anti-FcRn franchise.

argenx: Upgrading To 'Strong Buy' On Vyvgart's Q4 Sales, Empasiprubart Data, Pipeline Expansion

Availability of VYVGART ® and self-administered VYVDURA demonstrates continued commitment to providing more choice and flexibility for gMG patients in Japan Jan. 18, 2024, 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 autoimmune diseases, today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) approved VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) injection for subcutaneous (SC) use for the treatment of adult patients with generalized myasthenia gravis (gMG), who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). Following this decision, VYVGART is now approved in Japan for both intravenous (IV) and self-administered SC use.

argenx Announces Approval of VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use in Japan for Generalized Myasthenia Gravis

LOS ANGELES, CA / ACCESSWIRE / January 17, 2024 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of argenx SE ("Argenx" or "the Company") (NASDAQ:ARGX) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

INVESTOR ACTION ALERT: The Schall Law Firm Announces it is Investigating Claims Against argenx SE and Encourages Investors with Losses to Contact the Firm

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Argenx (ARGX) has seen solid earnings estimate revision activity over the past month, and belongs to a strong industry as well.

How Argenx (ARGX) Stock Stands Out in a Strong Industry

LOS ANGELES, CA / ACCESSWIRE / January 12, 2024 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of argenx SE ("Argenx" or "the Company") (NASDAQ:ARGX) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

INVESTIGATION ALERT: The Schall Law Firm Announces it is Investigating Claims Against argenx SE and Encourages Investors with Losses to Contact the Firm

LOS ANGELES, CA / ACCESSWIRE / January 10, 2024 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of argenx SE ("Argenx" or "the Company") (NASDAQ:ARGX) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

IMPORTANT INVESTOR ALERT: The Schall Law Firm Announces it is Investigating Claims Against argenx SE and Encourages Investors with Losses to Contact the Firm

Reported $1.2 billion in preliminary* full-year 2023 global net product sales Submitted sBLA to FDA for VYVGART ® Hytrulo for CIDP with priority review voucher (PRV); if approved, launch expected mid-2024 Reported positive data from Phase 2 ARDA study establishing proof-of-concept for empasiprubart in MMN Data from six Phase 2 proof-of-concept trials expected by end of 2024 Nominated four new pipeline candidates with IND filings expected by end of 2025 January 8, 2024, 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 autoimmune diseases, today reported preliminary financial results for the full-year 2023, including global net product sales (inclusive of both VYVGART® and VYVGART Hytrulo), and announced its strategic priorities for 2024. “In 2023, we reached more than 6,000 patients globally, making VYVGART available to gMG patients around the world,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

argenx Highlights 2024 Strategic Priorities

Amsterdam, the Netherlands – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that Tim Van Hauwermeiren, Chief Executive Officer, will present at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 at 9:00 a.m. PT.

argenx to Present at 42nd Annual J.P. Morgan Healthcare Conference

LOS ANGELES, CA / ACCESSWIRE / December 28, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of argenx SE ("Argenx" or "the Company") (NASDAQ:ARGX) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

INVESTOR ACTION NOTICE: The Schall Law Firm Announces it is Investigating Claims Against argenx SE and Encourages Investors with Losses to Contact the Firm

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argenx's (ARGX) phase III ADDRESS study, evaluating efgartigimod subcutaneous for treating pemphigus, fails to meet primary and secondary endpoints. Stock falls.

argenx (ARGX) Tanks on Top-Line Data From Pemphigus Study

LOS ANGELES, CA / ACCESSWIRE / December 20, 2023 / The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of argenx SE ("Argenx" or "the Company") (NASDAQ:ARGX) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

ONGOING INVESTOR ALERT: The Schall Law Firm Announces it is Investigating Claims Against argenx SE and Encourages Investors with Losses to Contact the Firm

Shares of biotechnology specialist Argenx (NASDAQ: ARGX ) — which focuses on addressing severe autoimmune diseases – suffered a hefty decline on Wednesday following a clinical disappointment. Its Phase 3 study for a disease that causes skin blisters failed to meet its primary and secondary objectives.

Why Is Argenx (ARGX) Stock Down 25% Today?

Argenx SE (NASDAQ: ARGX) says a late-stage trial of its candidate drug for an autoimmune condition failed to meet the primary or secondary endpoints. Its shares are down 25% at writing.

This biotech stock is down 25% on Wednesday: find out why

Shares of argenx plummeted after lead asset Vyvgart (efgartigimod) failed to meet endpoints in a phase 3 trial for the treatment of pemphigus vulgaris and pemphigus foliaceus. The failure also has negative implications for the bullous pemphigoid trial, leading the company to delay a go/no go decision. Despite the setback, argenx's Vyvgart continues to impress with strong global net sales, and the long-term outlook for the stock remains favorable.

argenx: Back To Earth After 2 Clinical Trial Failures

Argenx dived after its antibody therapy for an autoimmune disease that causes skin blisters failed to beat a placebo in a phase 3 trial.

Argenx Dives On Autoimmune Therapy Failure

Argenx stock ARGX, -33.70% ARGX, -0.64% lost a third of its value as the Amsterdam biotech said a late-stage trial did not meet primary or secondary endpoints. The Phase 3 study was of using efgartigimod subcutaneous in adults with pemphigus vulgaris and pemphigus foliaceus.

Argenx stock dives by a third after late-stage trial didn't meet goals

ADDRESS study did not meet primary or secondary endpoints Pemphigus deprioritized as efgartigimod indication Update on BALLAD study GO/NO GO decision Conference call scheduled for today, December 20, 2023, at 8:30am ET (2:30pm CET) Regulated Information – Inside Information December 20, 2023, 7:00am CET AMSTERDAM, THE NETHERLANDS — argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced topline results from the ADDRESS study evaluating efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adults with pemphigus vulgaris (PV) and pemphigus foliaceus (PF). The ADDRESS results show the proportion of PV patients achieving the primary endpoint of complete remission on a minimal dose of steroids (CRmin) was not significantly different between efgartigimod SC and placebo.

argenx Reports Topline Results from ADDRESS Study of Efgartigimod SC in Pemphigus

Argenx stock plummeted Tuesday after the company's drug unexpectedly failed to help patients with a rare blood disorder.

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