Argenx Se Stock Price, News & Analysis

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.

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.