Welcome to our dedicated page for Argenx Se news (Ticker: ARGX), a resource for investors and traders seeking the latest updates and insights on Argenx Se stock.
argenx SE (ARGX) is a global immunology leader developing antibody-based therapies for rare autoimmune diseases and neuromuscular disorders. This page provides real-time news updates on clinical advancements, regulatory milestones, and strategic initiatives shaping the company’s trajectory.
Investors and industry professionals will find a curated collection of press releases, earnings reports, and partnership announcements. Key focus areas include updates on treatments for myasthenia gravis, CIDP, and thyroid eye disease, alongside innovations like subcutaneous formulations enhancing patient care.
Our repository ensures access to verified developments in ARGX’s clinical pipeline, FDA/EMA interactions, and research collaborations. Content is organized for quick scanning while maintaining scientific accuracy, balancing technical detail with investor-centric insights.
Bookmark this page for streamlined tracking of ARGX’s progress in advancing immunology solutions. Check regularly for authoritative updates on trial results, commercialization efforts, and industry recognition driving the company’s global impact.
argenx announced the validation of its marketing authorization application (MAA) for efgartigimod as a treatment for generalized myasthenia gravis (gMG) by the European Medicines Agency (EMA). This marks a significant step in the regulatory process, which began on August 19, 2021, with a decision expected by mid-2022. If approved, efgartigimod will be the first FcRn antagonist in Europe. The application is supported by positive results from the Phase 3 ADAPT trial involving 167 patients across North America, Europe, and Japan. The FDA and Japanese authorities are also reviewing the drug.
argenx (Euronext & Nasdaq: ARGX), a global immunology company, announced its participation in a fireside chat at the 2021 Wedbush PacGrow Virtual Healthcare Conference on August 11, 2021, at 11:30 a.m. ET. A live webcast will be available on the argenx website, with a replay accessible for 90 days post-event. The company is dedicated to developing novel antibody-based treatments for serious autoimmune diseases and cancer.
On July 29, 2021, argenx (ARGX) reported a significant increase in revenue, totaling $470.4 million for the first half of 2021, up from $24.7 million in 2020. The company emphasizes its progress with efgartigimod, targeting a December 17, 2021, BLA approval in the U.S. for generalized myasthenia gravis (gMG), and plans to expand its indications. The 'argenx 2025' vision aims for global availability and a comprehensive immunology pipeline. Cash positions rose to $2.73 billion, supported by previous funding and collaborations.
On July 22, 2021, argenx (Euronext & Nasdaq: ARGX) announced a conference call scheduled for July 29, 2021, at 2:30 p.m. CET to discuss its half-year 2021 financial results and provide a business update for the second quarter. The live call will be accessible via the Investors section on the argenx website, with a replay available for a year. argenx focuses on innovative antibody-based therapies for severe autoimmune diseases and cancer, and is actively evaluating multiple candidates in serious indications.
argenx (Euronext & Nasdaq: ARGX) will host a virtual R&D Day on July 20, 2021, at 3:00 p.m. CET (9:00 a.m. ET) to unveil its 'argenx 2025 vision' and update its immunology pipeline. Key announcements include the introduction of new indications for the FcRn antagonist, efgartigimod, alongside Phase 1 data for ARGX-117. The event features expert discussions, including Dr. Rohit Aggarwal and Dr. Russell P. Hall III. A dedicated microsite will host a live webcast and further resources. Access it through the argenx investors' page.
Argentx announced positive results from the Phase 3 ADAPT trial of efgartigimod, a treatment for generalized myasthenia gravis (gMG). The trial showed that 67.7% of patients treated with efgartigimod experienced significant improvement on the Myasthenia Gravis Activities of Daily Living (MG-ADL) score compared to 29.7% in the placebo group (p<0.0001). Efgartigimod is under FDA review with a PDUFA target action date of December 17, 2021. If approved, it would be the first FcRn antagonist for gMG, aiming to improve the quality of life for patients suffering from this debilitating disease.
On June 7, 2021, argenx SE (ARGX) announced it regained worldwide rights to the anti-CD70 antibody cusatuzumab from Cilag GmbH International. Interim data from the Phase 1b ELEVATE trial shows promising results for cusatuzumab in treating acute myeloid leukemia (AML), with a 48% complete remission rate and an overall response rate of 93%. The trial involves 44 patients, indicating cusatuzumab's potential benefits while being well-tolerated. The collaboration with Janssen was initiated in 2018, bringing in $525 million in payments and investments, but was recently discontinued.
On June 1, 2021, argenx announced the appointment of Mr. Karl Gubitz as Chief Financial Officer, succeeding Eric Castaldi, who will remain until June 30, 2021. Gubitz, with nearly 20 years of experience in global pharmaceutical finance, previously held a Vice President role at Pfizer. His expertise is expected to strengthen argenx's strategic financial direction as the company approaches the anticipated commercial launch of its lead product, efgartigimod. Gubitz's appointment comes during a pivotal time for the company, enhancing its position in the immunology sector.
argenx (Euronext & Nasdaq: ARGX) announced management's participation in several upcoming investor conferences. Key events include the Goldman Sachs 42nd Annual Global Healthcare Conference on June 8, JMP Securities Life Sciences Conference on June 16, J.P. Morgan European Healthcare Conference on June 17, and Raymond James Human Health Innovation Conference on June 22, 2021. The company focuses on developing treatments for severe autoimmune diseases and cancer, including efgartigimod and cusatuzumab.
argenx reported strong first-quarter 2021 results with revenue soaring to $158 million, a significant increase from $21 million in Q1 2020. The company announced that the Japanese Marketing Authorization Application for efgartigimod was accepted for review, following similar FDA acceptance in the U.S. with a target decision date of December 17, 2021. The firm is advancing registrational trials across multiple indications and plans to initiate two additional indications this year. Cash and equivalents reached $2.9 billion, bolstered by a public offering that raised $1.15 billion.
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