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.

$478 million in second quarter global net product sales First CIDP patients treated with VYVGART ® Hytrulo following June 21 st FDA approval On track to begin four additional registrational studies across efgartigimod and empasiprubart by end of 2024 Management to host conference call today at 2:30 PM CET (8:30 AM ET) Regulated Information – Inside Information July 25, 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 its half year 2024 results and provided a second quarter business update. “We were excited to unveil our ambition for the future of argenx – Vision 2030 – last week, outlining our plan to develop and deliver continued and sustainable innovation for patients,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

argenx Reports Half Year 2024 Financial Results and Provides Second Quarter Business Update

July 18, 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, July 25, 2024 at 2:30 PM CET (8:30 AM ET) to discuss its half year 2024 financial results and provide a second quarter business update.

argenx to Report Half Year 2024 Financial Results and Second Quarter Business Update on July 25, 2024

First and only NMPA-approved subcutaneous injectable FcRn blocker for gMG patients in China Consistent clinical benefit and safety profile of efgartigimod SC compared to IV demonstrated in Phase 3 ADAPT-SC study July 16, 2024 6:30am CET Amsterdam, the Netherlands— argenx SE (Euronext & Nasdaq: ARGX) and Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) today announced that China's National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) on July 16, 2024 for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC), 1,000mg (5.6ml)/vial indicated 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. ​​​“The NMPA approval for efgartigimod SC is yet another key milestone on our journey to expand into new patient populations around the world with our transformative medicine.

argenx and Zai Lab Announce Approval of Efgartigimod Alfa Injection (Subcutaneous Injection) for Generalized Myasthenia Gravis in China

Zai Lab Ltd.

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and argenx (Euronext & Nasdaq: ARGX) today announced that China's National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC), 1,000mg (5.6ml)/vial indicated as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine.

Zai Lab and argenx Announce Approval of Efgartigimod Alfa Injection (Subcutaneous Injection) for Generalized Myasthenia Gravis in China

Argenx's shares rose after FDA approval of Vyvgart for the treatment of CIDP. The approval expands the addressable market for Vyvgart, and the company will initially target 12,000 patients in the U.S. who are currently not well controlled on other drugs. The filing with the FDA for the prefilled syringe for Vyvgart was completed, and it represents another potential growth driver in 2025 and a key defensive step in the long-term.

Argenx: Strong Setup For Outperformance In 2025

ARDA study data show potential for empasiprubart to drive functional improvement and reduced risk of relapse for multifocal motor neuropathy (MMN) patients

argenx Highlights Breadth of Autoimmune Pipeline with New Multifocal Motor Neuropathy Data at 2024 Peripheral Nerve Society Annual Meeting

Argenx (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.

Argenx (ARGX) Surges 11.7%: Is This an Indication of Further Gains?

Friday, the FDA approved Argenx SE's ARGX Vyvgart Hytrulo for use in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

Why Is European Drugmaker Argenx Stock Trading Higher On Monday?

Per argenx (ARGX), the label expansion to Vyvgart Hytrulo makes it the first FDA-approved medication with a novel mechanism of action to treat chronic inflammatory demyelinating polyneuropathy.

FDA Expands argenx's (ARGX) Vyvgart Label to Treat Rare Disorder

Argenx stock surged Monday after the FDA approved its drug, Vyvgart Hytrulo, for patients with an autoimmune condition known as CIDP.

Argenx Surges After Its Bread-And-Butter Drug Wins Another FDA Approval

VYVGART® Hytrulo is first and only neonatal Fc receptor (FcRn) blocker approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP)

argenx Announces FDA Approval of VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy

R&D Day presentations to include recent Phase 2 datasets in Sjogren's disease (efgartigimod) and multifocal motor neuropathy (empasiprubart) that support advancement to Phase 3 development

argenx to unveil its ‘Vision 2030: Taking Breakthrough Science to 50,000 Patients' during its Upcoming R&D Day on July 16, 2024

June 4, 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 members of management will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024 at 2:40 PM ET in Miami, FL.

argenx to Present at Goldman Sachs 45th Annual Global Healthcare Conference

argenx SE (NASDAQ:ARGX ) Q1 2024 Earnings Conference Call May 9, 2024 8:30 AM ET Company Participants Beth DelGiacco - Vice President, Global Head 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 Tazeen Ahmad - Bank of America Securities Rajan Sharma - Goldman Sachs Derek Archila - Wells Fargo James Gordon - JPMorgan Akash Tewari - Jefferies Yaron Werber - TD Cowen Brian Conley - Leerink Partners Alex Thompson - Stifel Xian Deng - UBS Vikram Purohit - Morgan Stanley Danielle Brill - Raymond James Samantha Semenkow - Citi Gavin Clark-Gartner - Evercore ISI Yatin Suneja - Guggenheim Victor Floch - BNP Paribas Joel Beatty - Baird Manos Mastorakis - Deutsche Bank Matt Phipps - William Blair Douglas Tsao - H. C. Wainwright Operator Good morning.

argenx SE (ARGX) Q1 2024 Earnings Call Transcript

$398 million in first quarter global net product sales FDA review ongoing for CIDP sBLA with PDUFA target action date of June 21, 2024 On track to submit filing for pre-filled syringe (PFS) in second quarter 2024 Management to host conference call today at 2:30 PM CET (8:30 AM ET) May 9, 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 its first quarter 2024 results and provided a business update. “The team at argenx has made significant progress executing across the ambitious plan we set out at the beginning of the year,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

argenx Reports First Quarter 2024 Financial Results and Provides Business Update

argenx (ARGX) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.

Is a Surprise Coming for argenx (ARGX) This Earnings Season?

May 7, 2024 – 5:30pm ET 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 the results of its Annual General Meeting of shareholders held today. All items on the agenda received a majority of votes in favor except for agenda item 5 (adoption of the remuneration policy).

argenx announces results of Annual General Meeting of Shareholders

argenx stock has decreased by 22% since the last evaluation, reflecting operational challenges and market conditions. The company is facing competition in the clinic, particularly from Immunovant's IMVT-1402 and Johnson & Johnson's nipocalimab. Despite high R&D and SG&A expenses leading to losses, argenx reported substantial revenue growth and maintains a strong cash position.

argenx: Innovation Over Losses In Autoimmune Arena

May 7, 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 members of the management team will participate in a fireside chat at the BofA Securities 2024 Health Care Conference on Tuesday, May 14, 2024 at 10:00 AM PT in Las Vegas, NV.

argenx to Present at BofA Securities 2024 Health Care Conference

May 2, 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, May 9, 2024 at 2:30 PM CET (8:30 AM ET) to discuss its first quarter 2024 financial results and provide a business update.

argenx to Report First Quarter 2024 Financial Results and Business Update on May 9, 2024

ADHERE data show VYVGART ® Hytrulo has potential to be first advancement for CIDP patients in 30 years

argenx Data Highlight Evidence that VYVGART and VYVGART Hytrulo Drive Transformative Outcomes for Patients with Debilitating Autoimmune Disease

RHO study supports proof-of-concept in primary Sjogren's disease Decision informed by favorable safety profile and consistency across efficacy and biomarker measures March 27, 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 its plan to continue the development of efgartigimod to Phase 3 in adults with primary Sjogren's disease (SjD), following the analysis of topline data from the Phase 2 RHO study. Detailed results will be presented at a future medical meeting.

argenx Advances Clinical Development of Efgartigimod in Primary Sjogren's Disease

March 26, 2024 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 Annual General Meeting of shareholders will be held at 13:00 CET on Tuesday, May 7, 2024 at the Hilton Amsterdam Schiphol at Schiphol Boulevard 701, 1118 BN Schiphol, the Netherlands. The shareholders and all other persons with meeting rights are invited to attend the Annual General Meeting of shareholders.

argenx Announces Annual General Meeting of Shareholders on May 7, 2024

VYVGART ® now approved in Japan for both generalized myasthenia gravis and primary immune thrombocytopenia (ITP)

argenx Announces Approval of VYVGART (efgartigimod alfa) in Japan for Adults with Primary Immune Thrombocytopenia

Argenx (ARGX) surges after a Japanese rival posted disappointing results from a late-stage study on its investigational drug for generalized myasthenia gravis.

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