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 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.
On February 27, 2023, argenx announced the appointment of Steve Krognes as a non-executive director and chairperson of the Audit and Compliance Committee during an extraordinary general meeting of shareholders. This change is part of the company's long-term succession planning, resulting in the resignation of Werner Lanthaler from his previous roles. CEO Tim Van Hauwermeiren expressed confidence in Krognes’ financial and compliance expertise, and acknowledged Lanthaler's impactful contributions over eight years, which were instrumental in transforming argenx into a global immunology leader.
February 27, 2023 - argenx (Euronext & Nasdaq: ARGX), an immunology company, announced participation in key investor conferences in March. The Cowen 43rd Annual Healthcare Conference will feature a fireside chat on March 6, 2023, at 10:30 a.m. ET in Boston, MA. Additionally, the Raymond James 44th Annual Institutional Investors Conference will host a presentation on March 7, 2023, at 1:05 p.m. ET in Orlando, FL.
Investors can find more details on the argenx website.
argenx (Euronext & Nasdaq: ARGX), a global immunology company, announced a conference call on March 2, 2023, at 2:30 PM CET to discuss its full year 2022 financial results and provide a fourth quarter business update. Investors can access the live call at argenx.com/investors.
Additionally, dial-in options are available for various locations for those who wish to participate.
argenx has announced that the U.S. FDA will extend the review of its Biologics License Application for efgartigimod (1000mg efgartigimod-PH20) for treating generalized myasthenia gravis (gMG) to June 20, 2023. The FDA required this extension due to a major amendment in the information submitted, which necessitates additional review time. No further data or studies have been requested at this point. Luc Truyen, Chief Medical Officer, expressed confidence in the efficacy and safety profile of efgartigimod based on existing data. gMG is a chronic autoimmune disease characterized by debilitating muscle weakness, affecting thousands of patients.
Amsterdam, the Netherlands – On January 16, 2023, argenx SE (Euronext & Nasdaq: ARGX) announced an extraordinary general meeting of shareholders set for February 27, 2023, at the Hilton Amsterdam Schiphol. The meeting's sole agenda item is the proposed appointment of Steve Krognes as a non-executive director and Chair of the Audit and Compliance Committee. Following his appointment, Werner Lanthaler will resign from his director position after a notable eight-year term. The formal notice and further details on the meeting can be found on the argenx website.
argenx reported preliminary global net sales of VYVGART at approximately $402 million for 2022. The company anticipates key clinical developments in 2023, including the expected PDUFA action date of March 20, 2023 for U.S. FDA approval of its subcutaneous efgartigimod for generalized myasthenia gravis (gMG). argenx plans to expand its patient reach for VYVGART and begins a registrational trial in thyroid eye disease later in the year. With approximately $2.2 billion in cash, argenx projects to fund its operations towards profitability amidst ongoing clinical trials and market approvals.