argenx SE American Depositary Shares - ARGX STOCK NEWS

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.

argenx SE reported a strong third quarter 2022, achieving $131 million in global net sales from VYVGART® (efgartigimod alfa-fcab). The company filed a Biologics License Application for a subcutaneous formulation for generalized myasthenia gravis (gMG), with a launch expected in the first half of 2023. Despite high revenue, the company recorded a net loss of $235 million for the quarter. argenx is expanding its pipeline, with multiple ongoing clinical trials targeting severe autoimmune diseases. Management emphasizes growth potential and operational strategies moving forward.

argenx (ARGX) will host a conference call and audio webcast on October 27, 2022, at 2:30 pm CET to discuss its third quarter 2022 financial results and provide a business update. The event can be accessed via the Investors section of the argenx website. The company is known for its commitment to developing novel antibody-based medicines for severe autoimmune diseases, including its first-and-only approved neonatal Fc receptor (FcRn) blocker.

argenx SE (ARGX) announced the submission of a Biologics License Application (BLA) for subcutaneous (SC) efgartigimod to the U.S. FDA for treating generalized myasthenia gravis (gMG) in adults. This follows positive results from the Phase 3 ADAPT-SC trial, where SC efgartigimod demonstrated noninferiority to intravenously administered VYVGART in reducing total immunoglobulin G (IgG) levels after 29 days. Key data included a 66.4% mean reduction in total IgG levels for SC efgartigimod compared to 62.2% for VYVGART. The safety profile was consistent with prior studies, with injection site reactions being the most common side effects.

argenx SE (NASDAQ: ARGX) presented new data at the AANEM Annual Meeting, highlighting the effectiveness and safety of VYVGART (efgartigimod alfa-fcab) for treating generalized myasthenia gravis (gMG). Findings from the ADAPT+ study indicate consistent improvements in patient function and strength over multiple years. New pooled data reveal significant disease score improvements in seronegative gMG patients. The presentations emphasize argenx's commitment to innovation in treating autoimmune diseases, supported by 17 scientific abstracts accepted at the meetings.