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 operates as a global immunology company developing antibody-based therapies for severe autoimmune diseases and cancer. The company's news flow typically includes updates on clinical trial results, regulatory decisions from agencies like the FDA and European Medicines Agency, and corporate developments related to its therapeutic pipeline and commercialization efforts.
For investors tracking Argenx, news coverage centers on several key areas. Clinical trial announcements provide insight into the company's drug development progress across multiple autoimmune indications, including data readouts from pivotal studies that determine regulatory approval pathways. Regulatory milestones such as approvals, label expansions, or agency feedback represent material events affecting the company's ability to commercialize therapies. Financial reports detail the company's commercial execution, research and development spending, and cash position—critical factors for a specialty biopharmaceutical company balancing product sales with ongoing clinical investments.
The company generates news through scientific presentations at medical conferences, where researchers share clinical data and therapeutic insights with the medical community. These events often precede regulatory submissions or provide updates on ongoing studies. Additionally, corporate announcements regarding partnerships, manufacturing agreements, or strategic initiatives offer perspective on how Argenx structures its operations and allocates resources across its pipeline.
Because Argenx operates in the biotechnology sector focused on rare and severe diseases, its news cycle reflects the lengthy and complex nature of drug development. Investors monitoring this company should pay attention to enrollment milestones in clinical trials, interim data analyses, regulatory interactions, and commercial traction for approved products. The company's position as a foreign issuer means it files reports under different regulatory frameworks than domestic companies, which influences the timing and format of its disclosures.
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.
Amsterdam, January 3, 2023 – argenx (ARGX), a global immunology company focused on severe autoimmune diseases, will have its CEO, Tim Van Hauwermeiren, present at the 41st Annual J.P. Morgan Healthcare Conference on January 9, 2023, at 9:00 a.m. PT. A live webcast of the presentation will be available on the argenx investors page. A replay will be accessible for 30 days post-event.
On December 12, 2022, argenx SE announced the appointment of Ana Cespedes as a non-executive director during its extraordinary general meeting. Cespedes brings extensive experience in commercialization, access, and organizational effectiveness, which could enhance the company's strategic initiatives. Shareholders can find the voting results and related documents on the argenx website. argenx is dedicated to addressing severe autoimmune diseases and has developed the first approved neonatal Fc receptor blocker across the U.S., Japan, and EU.
On December 10, 2022, argenx SE presented promising results from its ADVANCE trial for VYVGART (efgartigimod alfa-fcab) at the 64th American Society of Hematology Annual Meeting. This marks the first plenary selection for immune thrombocytopenia (ITP) in 15 years, highlighting the significant unmet need in this rare autoimmune disease.
VYVGART demonstrated a substantial improvement in platelet counts compared to placebo, with a sustained response observed in 21.8% of treated patients. Topline data from the follow-up ADVANCE-SC trial is expected in the second half of 2023.
argenx has announced its acquisition of a U.S. FDA Priority Review Voucher (PRV) for $102 million. The PRV allows expedited review of a Biologics License Application, potentially accelerating approval times. argenx plans to use this voucher for efgartigimod, a first-in-class drug targeting severe autoimmune diseases. This move reflects the company's commitment to improving treatment options and aims to support its goal of addressing 15 disease targets by 2025. The acquisition is pending customary closing conditions.
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