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argenx SE (ARGX) is a leading global immunology company dedicated to transforming the lives of individuals suffering from severe autoimmune diseases and cancer. Originating from the Netherlands, argenx focuses on leveraging its advanced antibody engineering technology to address rare and debilitating autoimmune conditions.
One of the company’s landmark achievements is the development and approval of Vyvgart (efgartigimod), a groundbreaking treatment for generalized myasthenia gravis. Vyvgart received approval from the U.S. FDA in December 2021, followed by subsequent approvals in Europe and Japan in 2022. This therapeutic advancement underscores argenx’s commitment to delivering innovative solutions for patients with unmet medical needs.
In addition to Vyvgart, argenx continues to drive forward with several promising projects aimed at expanding its portfolio of antibody-based medicines. The company’s dedication to translating immunology breakthroughs into novel treatments is reflected in its ongoing research and development activities. Notably, argenx is advancing clinical studies on VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), with a focus on delivering effective therapies to a broader patient population.
Financially, argenx is well-positioned to sustain its growth trajectory, backed by strategic partnerships and a solid pipeline of innovative products. The company collaborates with key stakeholders across the healthcare industry to enhance its research capabilities and expedite the development of new treatments.
For the latest updates and more detailed information, investors and media can contact:
Ben Petok - BPetok@argenx.com
Alexandra Roy (US) - ARoy@argenx.com
Lynn Elton (EU) - LElton@argenx.com
May 10, 2022 - argenx SE (Euronext & Nasdaq: ARGX) announced that all resolutions at its Annual General Meeting of Shareholders were passed. Approved resolutions include the endorsement of the annual report for 2021, advisory vote on the remuneration report, and the re-appointment of several directors for varying terms. The Board was authorized to issue shares representing up to 10% of the outstanding capital for the next 18 months. Deloitte Accountants B.V. was appointed as the auditor for the 2022 financial year.
argenx SE reported $21.2 million in net product sales for VYVGART during its initial U.S. commercial launch quarter. The company met its primary endpoint in the Phase 3 ADVANCE trial for treating primary immune thrombocytopenia (ITP). The commercial launch in Japan is set to begin this month, with additional approvals expected in Europe later this year. Despite strong initial sales, argenx faces a significant operating loss of $222.7 million for Q1 2022, largely due to increased R&D expenses and administrative costs. The company continues to invest in expanding its pipeline across multiple autoimmune indications.
argenx announced positive results from the Phase 3 ADVANCE trial of VYVGART (efgartigimod alfa-fcab) for adults with primary immune thrombocytopenia (ITP). The trial met its primary endpoint, showing a higher proportion of patients achieving sustained platelet response compared to placebo (21.8% vs. 5%, p=0.0316). Key secondary endpoints also demonstrated significant benefits. The safety profile of VYVGART was consistent with past trials. The ADVANCE-SC trial, which focuses on subcutaneous administration, is set to deliver topline data in Q1 2023.
argenx (ARGX) will participate in a fireside chat at the BofA Securities 2022 Healthcare Conference on May 11, 2022, at 10:40 a.m. P.T. in Las Vegas, NV. The event will be accessible via a live webcast on the company's Investors section of the argenx website, with a replay available for 90 days post-event. argenx aims to develop innovative antibody-based medicines for severe autoimmune diseases and is known for its pioneering work with the neonatal Fc receptor (FcRn) blocker.
argenx (Euronext & Nasdaq: ARGX) will host a conference call on May 5, 2022, at 2:30 pm CET (8:30 am ET) to discuss its Q1 2022 financial results and provide a business update. Investors can access the live audio webcast on the argenx website. A replay will be available for one year following the call.
Interim data from the ADAPT+ study show that long-term treatment with VYVGART leads to consistent improvements in disease scores for patients with generalized myasthenia gravis (gMG). The treatment demonstrated a favorable safety profile throughout multiple cycles. Conducted by argenx SE (ARGX), the ongoing Phase 3 study involved 139 patients, with an average treatment duration of 363 days. Results indicate repeatable efficacy and a low incidence of serious adverse effects, affirming VYVGART’s potential as a targeted therapy for gMG.
argenx SE (Euronext & Nasdaq: ARGX) announced interim data will be presented from the ADAPT+ study at the American Academy of Neurology Annual Meeting, April 2-7 in Seattle, WA. The ADAPT+ study evaluates the long-term safety, tolerability, and efficacy of VYVGART® (efgartigimod alfa-fcab) in adult patients with generalized myasthenia gravis (gMG). Key presentations include data on treatment burden and baseline characteristics from a pre-approval program. CEO Tim Van Hauwermeiren emphasized their commitment to improving outcomes for the gMG community.
argenx has announced that underwriters have fully exercised their option to purchase an additional 350,000 ordinary shares as part of a global offering, raising the total anticipated gross proceeds to approximately $805 million from 2,683,334 ordinary shares.
The offering, managed by J.P. Morgan and others, follows a filing with the SEC under an automatically effective shelf registration statement. This press release serves as informational and does not constitute an offer to sell securities.
argenx SE, a global immunology company, will hold its annual general meeting of shareholders on May 10, 2022, at Hilton Amsterdam Airport Schiphol. Important agenda items include re-appointments to the Board of Directors, discussion of the 2021 Annual Accounts, and an advisory vote on the 2021 remuneration report. Shareholders are encouraged to use electronic proxy voting. The full agenda and documents related to the meeting are available on the argenx website.
argenx SE has successfully completed a global offering, closing the sale of 2,333,334 ordinary shares for gross proceeds of approximately $700 million (around €637 million). The offering was managed by major financial institutions including J.P. Morgan and Morgan Stanley. The shares are listed on the regulated market of Euronext Brussels. This offering allows argenx to advance its pipeline of antibody-based medicines aimed at severe autoimmune diseases, bolstering its commitment to improving patient lives.
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