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 company listed on Euronext and Nasdaq that focuses on severe autoimmune diseases through antibody-based medicines. Its news flow centers on clinical data, regulatory milestones, commercial performance and strategic updates related to its FcRn-targeting medicine VYVGART and a broader pipeline of experimental antibodies.
Investors and healthcare observers following ARGX news can read about regulatory interactions such as the U.S. Food and Drug Administration’s acceptance for priority review of a supplemental Biologics License Application (sBLA) for VYVGART in acetylcholine receptor antibody seronegative generalized myasthenia gravis (gMG). Company announcements also cover Phase 3 trial readouts, including the ADAPT SERON study in seronegative gMG and other registrational programs across neuromuscular and autoimmune indications.
argenx regularly reports preliminary and quarterly financial results, highlighting global product net sales from the VYVGART franchise and outlining strategic priorities tied to its long-term "Vision 2030". News items describe the expansion of VYVGART and VYVGART Hytrulo across gMG, chronic inflammatory demyelinating polyneuropathy (CIDP) and immune thrombocytopenia (ITP) in certain regions, as well as progress with pipeline candidates such as empasiprubart and ARGX-119.
Corporate news includes leadership transitions, conference presentations at major medical and investor meetings, and updates from the company’s Immunology Innovation Program (IIP). For readers interested in ARGX stock and the evolution of its immunology franchise, this news feed provides a consolidated view of clinical, regulatory, commercial and corporate developments as disclosed in argenx press releases and related filings.
argenx (Euronext & Nasdaq: ARGX) will host a conference call and audio webcast on May 4, 2023, at 2:30 pm CET to discuss its first quarter 2023 financial results and provide a business update. The event will be available via the Investors section of their website. A replay will be accessible for one year. Dial-in numbers are provided for various countries including the U.S., U.K., and Japan.
As a global immunology company, argenx is focused on severe autoimmune diseases and has partnered with researchers through its Immunology Innovation Program. The company is currently evaluating the therapeutic potential of its approved neonatal Fc receptor (FcRn) blocker and advancing several experimental medicines.
argenx SE plans to present six abstracts at the 75th American Academy of Neurology (AAN) Annual Meeting from April 22-27, 2023, focusing on generalized myasthenia gravis (gMG). These presentations will feature clinical and real-world data regarding efgartigimod, an innovative treatment aimed at enhancing outcomes for gMG patients.
The highlights include findings from long-term extension studies of VYVGART® showcasing consistent reductions in IgG antibody levels and improved clinical results. A new analysis will explore the efficacy of efgartigimod in gMG patients early in their disease progression. Additionally, argenx will share insights on expanding patient support programs to address healthcare access challenges.
argenx and Genmab have formed a multiyear collaboration to jointly discover and commercialize novel antibody therapies targeting immunology and oncology. This partnership leverages both companies' expertise in antibody engineering to accelerate the development of treatments for unmet patient needs. The initial focus will be on two differentiated targets: one in immunology and one in cancer. Both companies will share costs and profits from products developed through this collaboration, aiming to unlock new therapeutic candidates that address patient needs more effectively.
argenx SE (Euronext & Nasdaq: ARGX) announced its Annual General Meeting of shareholders to be held on May 2, 2023, at Hilton Amsterdam Schiphol. The agenda includes the adoption of annual accounts for 2022, an advisory vote on the 2022 remuneration report, and proposals for director reappointments and external auditor appointments. Shareholders will also review the renewal of the Board's authority to issue shares. The annual report for the financial year ending December 31, 2022, is now available on the company's website. All relevant documents can be accessed there, and shareholders are encouraged to vote by proxy.
argenx announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for VYVGART® (efgartigimod alfa-fcab) as an add-on to standard therapy for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. Results from the Phase 3 ADAPT trial showed a significant response rate of 68% in patients treated with VYVGART compared to 30% in placebo (p<0.0001). The company emphasizes collaboration with local authorities to ensure rapid access for eligible patients. VYVGART is the first FcRn blocker approved in the UK for gMG treatment.
argenx has appointed Karen Massey as Chief Operating Officer, effective March 13, 2023. She will succeed Keith Woods, who will transition to an advisory role after supporting the launch of efgartigimod. Massey brings over 20 years of experience in the pharmaceutical sector, having led commercial operations for Ocrevus at Genentech. Her appointment follows a thorough succession planning process crucial for argenx’s growth as an immunology company. The company aims to leverage her expertise to further develop its pipeline and enhance market presence.
argenx reported strong financial results for 2022, with global net product sales of $173 million in Q4 and $401 million for the entire year from its therapy, VYVGART. The company aims to expand its market presence with plans for new regulatory approvals and the anticipated launch of SC efgartigimod for generalized myasthenia gravis (gMG). A PDUFA target action date is set for June 20, 2023. Newly appointed COO Karen Massey is leading a transition as Keith Woods retires. The firm expects to utilize up to $500 million in cash for operating expenses in 2023, emphasizing a robust pipeline with several key data readouts anticipated this year.