Argenx Se Stock Price, News & Analysis

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.

argenx SE (ARGX) announced that the FDA has accepted its Biologics License Application (BLA) for subcutaneous efgartigimod, targeting a PDUFA date of March 20, 2023. This innovative treatment is aimed at adult patients with generalized myasthenia gravis (gMG). The BLA is backed by positive results from the Phase 3 ADAPT-SC study, demonstrating noninferiority in total IgG reduction compared to VYVGART. Efgartigimod reduces IgG autoantibodies, potentially enhancing treatment flexibility. If approved, it will be the second commercial product for argenx.

On November 7, 2022, argenx (ARGX), a global immunology company, announced its participation in several investor conferences throughout November. Key events include:

• Guggenheim Healthcare Talks: Fireside chat on November 14 at 11:20 a.m. ET, New York.
• Stifel 2022 Healthcare Conference: Fireside chat on November 15 at 4:45 p.m. ET, New York.
• Jefferies London Healthcare Conference: Investor meetings on November 16, London.
• Evercore ISI 5th Annual HealthCONx Conference: Virtual chat on November 29 at 10:55 a.m. ET.
• Piper Sandler 34th Annual Healthcare Conference: Fireside chat on November 30 at 1:00 p.m. ET, New York.

Details on these events can be found on the argenx investor website.