Loading...Loading...Friday, the FDA approved Argenx SE’s ARGX Vyvgart Hytrulo for use in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).Vyvgart Hytrulo is approved for CIDP as a once-weekly 30-to-90-second subcutaneous injection. It is the first and only neonatal Fc receptor (FcRn) blocker approved for CIDP.CIDP is an autoimmune disorder in which the body’s immune system attacks the myelin that insulates and protects the body’s nerves. It causes muscle weakness, numbness, and other s ...

Shares of argenx (ARGX) rose nearly 4% on Friday after management announced that the FDA approved its subcutaneously administered Vyvgart Hytrulo (efgartigimod) for a second indication — chronic inflammatory demyelinating polyneuropathy (CIDP).Vyvgart Hytrulo has been approved as a once-weekly 30-to-90-second subcutaneous injection to treat adult patients with CIDP, a rare autoimmune disease. Per argenx, the approval ofVyvgart Hytrulo makes it the first FDA-approved medication with a novel mechanism of acti ...

Core Insights - The FDA has approved VYVGART Hytrulo as the first and only neonatal Fc receptor (FcRn) blocker for treating chronic inflammatory demyelinating polyneuropathy (CIDP), marking a significant advancement in treatment options for this condition [2][3][5] - VYVGART Hytrulo represents the first novel mechanism of action for CIDP in over 30 years, providing a new therapeutic option for patients who have been waiting for innovative treatments [3][4] - The approval is based on the ADHERE Study, which demonstrated that 69% of patients treated with VYVGART Hytrulo showed clinical improvement, with a 61% reduction in the risk of relapse compared to placebo [5][16] Company Overview - Argenx SE is a global immunology company focused on developing treatments for severe autoimmune diseases, with a commitment to improving patient lives [2][19] - The company has developed VYVGART Hytrulo, which combines efgartigimod alfa and hyaluronidase-qvfc, facilitating subcutaneous injection delivery of biologics [17] - Argenx is also evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier-stage experimental medicines [19] Treatment Context - CIDP is a rare and debilitating autoimmune disease affecting the peripheral nervous system, with significant impacts on patients' mobility and quality of life [3][18] - Current treatment options have been limited to corticosteroids and plasma-derived therapies, which can be burdensome for patients [5][4] - The introduction of VYVGART Hytrulo provides a new, safe, and effective treatment option that may alleviate some of the treatment burdens faced by CIDP patients [5][4] Clinical Study Insights - The ADHERE trial was the largest clinical trial to date for CIDP, enrolling 322 adult patients and demonstrating significant clinical benefits from VYVGART Hytrulo [5][16] - The trial's primary endpoint was met with a statistically significant reduction in relapse risk, affirming the efficacy of VYVGART Hytrulo in treating CIDP [5][16] Patient Access and Support - VYVGART Hytrulo is expected to be available for patients in the U.S. immediately, with a patient support program, My VYVGART Path, established to assist with access and education [7][19] - The annual out-of-pocket cost for patients is expected to be comparable to existing treatments for CIDP and generalized myasthenia gravis [7]

VYVGART® Hytrulo is first and only neonatal Fc receptor (FcRn) blocker approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP) First novel, precision mechanism of action in more than 30 years for patients with CIDP Third approved indication for VYVGART® and VYVGART Hytrulo franchise Management to host conference call on June 21, 2024 at 11:00pm CET (5:00pm ET) June 21, 2024, 4:40pm ET   Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committe ...

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 Next wave of innovative pipeline candidates to be introduced highlighting long-term commitment to transform autoimmunity Decision to not advance development of efgartigimod in PC-POTS based on Phase 2 ALPHA data June 17, 2024, 7:00 AM CET Amsterdam, the Netherlands – argenx SE ((Euronext &amp, NASDAQ:ARGX), a global im ...

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 Next wave of innovative pipeline candidates to be introduced highlighting long-term commitment to transform autoimmunity Decision to not advance development of efgartigimod in PC-POTS based on Phase 2 ALPHA data June 17, 2024, 7:00 AM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immuno ...

June 4, 2024Amsterdam, the Netherlands – argenx ((Euronext &amp, 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. A live webcast of the fireside chat may be accessed on the Investors section of the argenx website at argenx.com/investors. ...

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 - ...

Core Insights - argenx SE reported global net product sales of $398 million in the first quarter of 2024, a significant increase from $218 million in the same period of 2023, reflecting strong growth driven by the VYVGART product line [5][10][12] - The company is preparing for regulatory submissions and trials for its products, including a Supplemental Biologics License Application (sBLA) for CIDP with a PDUFA target action date of June 21, 2024, and a filing for a pre-filled syringe expected in the second quarter of 2024 [5][6][12] - argenx is advancing its pipeline with multiple programs, including registrational trials for efgartigimod in various autoimmune diseases, and aims to solidify its leadership in FcRn biology with expectations of approvals in at least 15 indications by 2025 [6][7][8] Financial Performance - Total operating income for Q1 2024 was $413 million, up from $230 million in Q1 2023, driven by product net sales and collaboration revenue [12][13] - Research and development expenses increased to $225 million in Q1 2024 from $166 million in Q1 2023, reflecting ongoing clinical development efforts [13][14] - The net loss for the period was $62 million, compared to a loss of $29 million in the same period last year, with a basic and diluted loss per share of $1.04 [15][16] Product Development and Regulatory Updates - VYVGART is now approved in over 30 countries for generalized myasthenia gravis (gMG) and has received approval in Japan for primary immune thrombocytopenia (ITP) [4][5] - The company is actively pursuing regulatory approvals for VYVGART and VYVGART SC in additional markets, including Switzerland, Australia, and China [5][6] - argenx is also advancing its pipeline with ongoing studies for efgartigimod in various conditions, including Sjogren's disease and thyroid eye disease, with data readouts expected throughout 2024 [7][8][9] Strategic Initiatives - The company continues to invest in its Immunology Innovation Program (IIP) to drive long-term pipeline growth, with four new pipeline candidates expected to be filed by the end of 2025 [8][20] - argenx has appointed Dr. Brian L. Kotzin as a non-executive director to enhance its research and development capabilities [9] - The company anticipates combined R&D and SG&A expenses to be less than $2 billion in 2024, with a net cash utilization of up to $500 million for operating expenses and capital expenditures [16]

May 7, 2024 – 5:30pm ET 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, 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). As part of the approved resolutions: The Company's annual report and annual accounts for the fina ...