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.

argenex SE (ARGX) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might help the stock continue moving higher in the near term.

argenex SE (ARGX) Surges 27.8%: Is This an Indication of Further Gains?

Regulated information — Inside information argenx announces launch of proposed global offering July 17 , 2023 Amsterdam , the Netherlands — argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced today that it has commenced a global offering of $750 million (approximately €668.6 million) of ordinary shares, which may be represented by American Depository Shares (“ADSs”). The global offering will be comprised of an offering of ordinary shares represented by ADSs in the United States and certain other countries outside of the European Economic Area and a simultaneous private placement of ordinary shares in the European Economic Area and the United Kingdom.

argenx announces launch of proposed global offering

Argenx's flagship autoimmune drug hit the primary endpoint in a registrational trial for a progressive nerve disorder. Investors are cheering the news today.

Why Argenx Stock Is on Fire Today

An Argenx drug beat expectations in a study of patients with a progressive nerve disorder and ARGX stock catapulted to a record high.

Argenx Catapults 27% To Record High As It Edges Closer To A New Multibillion-Dollar Market

Argenx (NASDAQ: ARGX ) stock is climbing higher on Monday following the release of data from a Phase 1 clinical trial. The company released results from its ADHERE study of VYVGART Hytrulo in adults with CIDP.

Why Is Argenx (ARGX) Stock Up 27% Today?

Study met primary endpoint (p=0.000039); VYVGART® Hytrulo demonstrated 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in risk of relapse versus placebo IgG autoantibodies shown to play significant role in underlying CIDP disease biology Favorable safety and tolerability profile consistent with previous clinical trials and confirmed safety profile of VYVGART® Conference call scheduled for today, July 17, 2023 at 8:30am ET (2:30pm CET) Regulated information – Inside information Amsterdam, The Netherlands – July 17 , 2023 – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced positive topline results from the ADHERE study evaluating VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The study met its primary endpoint (p=0.000039), demonstrating a significantly lower risk of relapse with VYVGART Hytrulo compared to placebo.

argenx Reports Positive Topline Data from ADHERE Study of VYVGART Hytrulo in Patients with Chronic Inflammatory Demyelinating Polyneuropathy

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China's National Medical Products Administration (NMPA) has approved Zai Lab Limited's and Argenx SE's Biologics License Application (BLA) for VYVGART, a treatment for generalised myasthenia gravis (gMG), muscle-weakening disease, in anti-body positive adults, the Dutch company said on Friday.

China's NMPA approves Argenx's and Zai Lab's BLA for muscle-weakening disease treatment

Amsterdam, the Netherlands— June 30, 2023 -- argenx SE (Euronext & Nasdaq: ARGX) and Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) today announced that China's National Medical Products Administration (NMPA) has approved the Biologics License Application (BLA) for VYVGART® (efgartigimod alfa injection), a first-in-class neonatal Fc receptor (FcRn) antagonist, as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. Zai Lab will now work with the National Healthcare Security Administration (NHSA) for NRDL inclusion to enable broad access for patients.

argenx and Zai Lab Announce Approval of VYVGART® (efgartigimod alfa injection) for Generalized Myasthenia Gravis in China

The U.S. Food and Drug Administration has approved Argenx SE's under-the-skin injection for the treatment of a muscle-weakening genetic disease called generalized myasthenia gravis, the company said on Tuesday.

US FDA approves Argenx's therapy for muscle-weakening disease

VYVGART ® Hytrulo is first FDA - approved subcutaneous (SC) inject able for generalized myasthenia gravis ( gMG ) With this approval, argenx broadens innovative gMG product offering and demonstrates continued commitment to providing more choice and flexibility for patients E fficacy of VYVGART Hytrulo was established by demonstrating a comparable pharmacodynamic (PD) effect to VYVGART ® in Phase 3 ADAPT-SC bridging study Management to host conference call tomorrow at 2:30pm CET (8:30 am ET) Regulated Information/Inside Information Amsterdam , the Netherlands— June 20 , 2023 —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) approved VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc). VYVGART Hytrulo is an injection for subcutaneous (SC) use for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

argenx Announces U.S. Food and Drug Administration Approval of VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Injection for Subcutaneous Use in Generalized Myasthenia Gravis

Independent Data Monitoring Committee recommend ed study continuation based on the favorable safety profile observed in the first dose cohort Early efficacy signals support proof-of-concept of empasiprubart in multifocal motor neuropathy Regulated Information/Inside Information Amsterdam, the Netherlands—June 20, 2023—argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced its plan to advance to a second dose cohort with the Phase 2 ARDA study of empasiprubart (ARGX-117) in multifocal motor neuropathy (MMN). The decision follows a planned interim analysis of the first dose cohort by an Independent Data Monitoring Committee (IDMC) meeting held on June 19, 2023.

argenx Initiates Second Cohort of Phase 2 ARDA Study of Empasiprubart in Multifocal Motor Neuropathy

Argenx could have "one of the biggest biologics of all time," the biotech company contends. Argenx stock now trades at a record high.

Argenx Believes It Might Have 'One Of The Biggest Biologics' Ever — And Shares Are Soaring

argenex SE (ARGX) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

All You Need to Know About argenex SE (ARGX) Rating Upgrade to Buy

argenx SE (NASDAQ:ARGX ) Q1 2023 Earnings Conference Call May 4, 2023 8:30 AM ET Company Participants Beth DelGiacco - Vice President of Corporate Communications and Investor Relations Tim Van Hauwermeiren - Chief Executive Officer Karl Gubitz - Chief Financial Officer Karen Massey - Chief Operating Officer Conference Call Participants Derek Archila - Wells Fargo Tazeen Ahmad - Bank of America Rajan Sharma - Goldman Sachs Yatin Suneja - Guggenheim Akash Tewari - Jefferies Thomas Smith - SVB Security Danielle Brill - Raymond James Joel Beatty - Baird Alex Thompson - Stifel Allison Bratzel - Piper Sandler Yaron Werber - Cowen Samantha Semenkow - Citi Myles Minter - William Blair Niall Alexander - Deutsche Bank Suzanne van Voorthuizen - Kempen & Company Trevor Allred - Oppenheimer Douglas Tsao - HCW Joon Lee - Truist Securities Charles Pitman - Barclays Simon Baker - Redburn Operator Good morning. My name is Rob, and I will be your conference operator today.

argenx SE (ARGX) Q1 2023 Earnings Call Transcript

$218 million in first quarter VYVGART® (efgartigimod alfa-fcab) global net product sales VYVGART received marketing authorization in Israel through partnership with Medison 88 events achieved in ADHERE trial; topline data now expected in July 2023 Enrollment completed in ADVANCE-SC and ADDRESS trials; topline data from both expected in fourth quarter of 2023 Management to host conference call today at 2:30 pm CET (8:30 am ET) Regulated Information/Inside Information May 4 , 202 3 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 its first quarter 2023 financial results and provided a business update. “Throughout the first quarter, we made significant progress advancing our mission to redefine what well-controlled means in the treatment of autoimmune diseases.

argenx Reports First Quarter 2023 Financial Results and Provides Business Update

May 2 , 202 3 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 members of management will participate in a fireside chat at the BofA Securities 2023 Health Care Conference on Tuesday, May 9, 2023, at 8:00 a.m. P.T. in Las Vegas, NV.

argenx to Present at BofA Securities 2023 Health Care Conference

April 27 , 202 3 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, May 4, 2023 at 2:30 pm CET (8:30 am ET) to discuss its first quarter 2023 financial results and provide a business update.

argenx to Report First Quarter 2023 Financial Results and Business Update on May 4, 2023

argenx: Exciting Genmab Partnership, All Eyes On Q1 Earnings And CIDP Readout.

argenx: Exciting Genmab Partnership, All Eyes On Q1 Earnings And CIDP Readout

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Amsterdam, the Netherlands – [0 4 / 18 /2023] argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that it will present six abstracts further demonstrating its long-term commitment to the generalized myasthenia gravis (gMG) community during the 75th American Academy of Neurology (AAN) Annual Meeting, which is taking place from April 22-27, 2023 in Boston, MA. The presentations include clinical and real-world efgartigimod data that demonstrate the potential of neonatal Fc receptor (FcRn) blockade in transforming treatment for gMG and other IgG-mediated autoimmune diseases.

argenx Demonstrates Commitment to Redefining Treatment Goals for Generalized Myasthenia Gravis with Multiple Presentations at American Academy of Neurology 2023 Annual Meeting

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Amsterdam, the Netherlands – 0 4 / 17 /2023 argenx SE (Euronext & Nasdaq: ARGX) and Genmab A/S (Nasdaq: GMAB) announced today that argenx and Genmab have entered into a collaboration agreement to jointly discover, develop and commercialize novel therapeutic antibodies with applications in immunology, as well as in oncology therapeutic areas. The multiyear collaboration will leverage the antibody engineering expertise and knowledge of disease biology of both companies to accelerate the identification and development of novel antibody therapeutic candidates with a goal to address unmet patient needs in immunology and cancer.

argenx and Genmab Enter Partnership to Advance Antibody Therapies in Immunology and Oncology

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Media Release COPENHAGEN, Denmark; April 1 7 , 2023 Genmab and  argenx   have entered a multiyear collaboration bringing together capabilities to jointly discover, develop and commercialize antibody therapies Discovery programs against two differentiated targets are underway    Genmab A/S  (Nasdaq: GMAB) and argenx  (Euronext & Nasdaq: ARGX) announced today that Genmab and  argenx  have entered into a collaboration agreement to jointly discover, develop and commercialize novel therapeutic antibodies with applications in immunology , as well as i n oncology therapeutic areas. The multiyear collaboration will leverage the antibody engineering expertise and knowledge of disease biology of both companies to accelerate the identification and development of novel antibody therapeutic candidates with a goal to address unmet patient needs in immunology and cancer.

Genmab and argenx Enter Partnership to Advance Antibody Therapies in Immunology and Oncology

argenx is a clinical-stage biotech company focused on developing antibody-based therapies for severe autoimmune diseases using its SIMPLE Antibody platform. Efgartigimod, argenx's lead product candidate, is a novel FcRn antagonist approved for the treatment of myasthenia gravis, a chronic autoimmune neuromuscular disorder.

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