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argenx SE (ARGX) is a leading global immunology company dedicated to transforming the lives of individuals suffering from severe autoimmune diseases and cancer. Originating from the Netherlands, argenx focuses on leveraging its advanced antibody engineering technology to address rare and debilitating autoimmune conditions.
One of the company’s landmark achievements is the development and approval of Vyvgart (efgartigimod), a groundbreaking treatment for generalized myasthenia gravis. Vyvgart received approval from the U.S. FDA in December 2021, followed by subsequent approvals in Europe and Japan in 2022. This therapeutic advancement underscores argenx’s commitment to delivering innovative solutions for patients with unmet medical needs.
In addition to Vyvgart, argenx continues to drive forward with several promising projects aimed at expanding its portfolio of antibody-based medicines. The company’s dedication to translating immunology breakthroughs into novel treatments is reflected in its ongoing research and development activities. Notably, argenx is advancing clinical studies on VYVGART Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), with a focus on delivering effective therapies to a broader patient population.
Financially, argenx is well-positioned to sustain its growth trajectory, backed by strategic partnerships and a solid pipeline of innovative products. The company collaborates with key stakeholders across the healthcare industry to enhance its research capabilities and expedite the development of new treatments.
For the latest updates and more detailed information, investors and media can contact:
Ben Petok - BPetok@argenx.com
Alexandra Roy (US) - ARoy@argenx.com
Lynn Elton (EU) - LElton@argenx.com
VYVGART™ (efgartigimod alfa), the first and only FcRn blocker, has received approval from Japan's Ministry of Health, Labour and Welfare for treating adults with generalized myasthenia gravis (gMG) unresponsive to standard therapies. This marks the second regulatory approval following its U.S. authorization on December 17, 2021. The approval supports argenx's global strategy to enhance access to this innovative treatment. VYVGART demonstrated significant efficacy in the Phase 3 ADAPT trial, showcasing superior response rates compared to placebo, reinforcing its potential in managing gMG.
argenx has announced the global commercial launch of VYVGART™ for the treatment of generalized myasthenia gravis. The company expects to report data from five registrational trials of efgartigimod by Q1 2023 and plans to initiate trials in four new indications, including lupus nephritis and Sjogren’s syndrome, in 2022. With approximately $2.3 billion in cash as of December 31, 2021, argenx anticipates a busy 2022, focusing on expanding its efgartigimod portfolio and maintaining its leadership in FcRn blockade.
argenx (Euronext & Nasdaq: ARGX), a global immunology company, announced that CEO Tim Van Hauwermeiren will present at the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022, at 7:30 a.m. ET. A live webcast will be available in the Investors section of the argenx website. The company is focused on severe autoimmune diseases and is commercializing VYVGART (efgartigimod alfa-fcab), the first FDA-approved neonatal Fc receptor blocker for generalized myasthenia gravis in adult patients. For more details, visit argenx.com.
argenx SE (Euronext & Nasdaq: ARGX) announced FDA approval for VYVGART™ (efgartigimod alfa-fcab) as the first and only FDA-approved neonatal Fc receptor blocker, targeting generalized myasthenia gravis (gMG) in anti-acetylcholine receptor (AChR) antibody-positive adult patients. In the Phase 3 ADAPT trial, 68% of treated patients were responders on the MG-ADL scale, compared to 30% for placebo (p<0.0001). The company has also secured value-based agreements with several payers and plans to support patient access through its My VYVGART Path program.
On November 10, 2021, argenx announced its participation in several key healthcare conferences aimed at discussing advancements in immunology. The events include:
- Guggenheim Healthcare Talks on November 15, 2021
- Evercore ISI HealthCONx Conference on November 30, 2021
- Piper Sandler Healthcare Conference, with a pre-recorded chat available on November 22, 2021
Details about these conferences can be found on the Investors section of the argenx website.
argenx (ARGX) announced its third-quarter 2021 financial results, highlighting the build-up of its commercial teams in the U.S. and Japan in preparation for the potential launch of efgartigimod for generalized myasthenia gravis (gMG). The company signed a partnership with Medison for the distribution of efgartigimod in Israel and is pursuing innovative collaborations in key markets. Financially, total operating income rose to $494.6 million due to significant collaboration revenue, while operating losses amounted to $117.8 million. Cash resources increased to $2.53 billion, attributed to a recent global offering.
argenx (ARGX), a global immunology company, will hold a conference call on October 28, 2021, at 2:30 PM CET to discuss its Q3 2021 financial results and offer a business update. The call will be accessible via the Investors section of their website, and a replay will be available for a year. argenx is focused on developing innovative antibody-based therapies for severe autoimmune diseases and cancer, actively evaluating its lead product efgartigimod.
argenx (ARGX) announced additional data from the Phase 3 ADAPT trial of efgartigimod for generalized myasthenia gravis (gMG). Key highlights include consistent depth of response and improvements in disease scores across patient subgroups. Notably, efgartigimod treatment does not impact vaccine immune responses. Initial findings from the MyRealWorld® MG research study shed light on the disease's severity and treatment burden on patients. The data will be showcased at upcoming neuromuscular conferences, enhancing the understanding of efgartigimod's potential benefits.
argenx (Euronext & Nasdaq: ARGX), a global immunology company, has announced its participation in several upcoming conferences focused on healthcare and biotechnology. Key events include the KBC Life Sciences & Biotech Virtual Conference on September 7, the Morgan Stanley Global Healthcare Conference on September 10, the BofA Global Healthcare Conference on September 16, and the SVB Leerink CybeRx Series event on September 22. Further details can be found on the Investors section of argenx's website.
argenx announced the validation of its marketing authorization application (MAA) for efgartigimod as a treatment for generalized myasthenia gravis (gMG) by the European Medicines Agency (EMA). This marks a significant step in the regulatory process, which began on August 19, 2021, with a decision expected by mid-2022. If approved, efgartigimod will be the first FcRn antagonist in Europe. The application is supported by positive results from the Phase 3 ADAPT trial involving 167 patients across North America, Europe, and Japan. The FDA and Japanese authorities are also reviewing the drug.
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