argenx SE American Depositary Shares - ARGX STOCK NEWS

argenx announced that its drug efgartigimod received a positive scientific opinion from the MHRA under the EAMS. This allows eligible patients with generalized myasthenia gravis (gMG) in the UK to access the treatment before official marketing authorization. The Medicine and Healthcare products Regulatory Agency granted efgartigimod a Promising Innovative Medicine (PIM) designation in November 2021. The European Medicines Agency is reviewing the marketing authorization application, with a decision expected in the second half of 2022.

argenx SE (Euronext & Nasdaq: ARGX) announced novel translational data from a Phase 2 study of efgartigimod for pemphigus, highlighting its potential role in autoimmune skin blistering disorders. The publication, presented at the Society for Investigative Dermatology Annual Meeting, reveals that efgartigimod treatment led to sustained reduction of antigen-specific B-cells, correlating with clinical improvement. The findings suggest efgartigimod may not only reduce IgG antibodies but also modulate B-cell activity and keratinocyte adhesion, addressing the unmet needs in pemphigus and bullous pemphigoid.

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.