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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
argenx reported strong financial results for Q2 2024, with global net product sales of $478 million. The company launched VYVGART Hytrulo for CIDP in the US and received NMPA approval for VYVGART SC in China for gMG. argenx unveiled its 'Vision 2030', aiming to reach 50,000 patients globally and achieve 10 labeled indications across approved assets by 2030. The company is advancing its pipeline, with plans to start four additional registrational studies for efgartigimod and empasiprubart by end of 2024. Financial highlights include total operating income of $489 million for Q2 2024, up from $281 million in Q2 2023. R&D expenses increased to $225 million, while SG&A expenses rose to $256 million. argenx ended Q2 with $3.1 billion in cash and equivalents.
argenx (Euronext & Nasdaq: ARGX), a global immunology company, has announced it will host a conference call and audio webcast on Thursday, July 25, 2024, at 2:30 PM CET (8:30 AM ET) to discuss its half year 2024 financial results and provide a second quarter business update. Investors can access the webcast on the company's website, with a replay available for approximately one year. The company has provided dial-in numbers for various countries, including Belgium, France, Netherlands, United Kingdom, United States, Japan, and Switzerland. Participants are advised to dial in 15 minutes before the live call using the access code 3810049.
Zai Lab (NASDAQ: ZLAB) and argenx announced the approval of efgartigimod alfa injection (subcutaneous injection) by China's NMPA for treating adult generalized myasthenia gravis (gMG) patients who are anti-AChR antibody positive. This marks the first and only NMPA-approved subcutaneous injectable for gMG in China, offering additional flexibility for patients.
The approval is based on the Phase 3 ADAPT-SC study, which demonstrated consistent clinical benefit and safety compared to the IV formulation. Efgartigimod SC showed a 66.4% mean total IgG reduction from baseline at day 29, compared to 62.2% with IV administration. The most common adverse event was mild to moderate injection site reactions.
This approval enhances treatment options for the estimated 170,000 gMG patients in China, allowing for a more individualized approach. Zai Lab reported 2,700 new patients starting VYVGART IV treatment in Q1 2024, highlighting the significant unmet need in the market.
argenx SE presented new data from its autoimmune pipeline at the 2024 Peripheral Nerve Society Annual Meeting. Key highlights include Phase 2 ARDA study results showing empasiprubart's potential to improve function and reduce relapse risk in multifocal motor neuropathy (MMN) patients. The ARDA study is the largest interventional study in MMN, showing a 91% reduction in the risk of IVIg retreatment. Additionally, VYVGART Hytrulo demonstrated sustained efficacy and safety in treating chronic inflammatory demyelinating polyneuropathy (CIDP) with a 61% reduction in relapse risk and consistent functional improvements in the ADHERE and ADHERE+ studies. VYVGART Hytrulo received FDA approval on June 21, 2024.
argenx announced the FDA approval of VYVGART Hytrulo for treating chronic inflammatory demyelinating polyneuropathy (CIDP).
This is the first neonatal Fc receptor (FcRn) blocker approved for CIDP and marks the first novel treatment mechanism in over 30 years for this condition.
The approval is based on the ADHERE study, which showed significant clinical improvements in 69% of patients. The study met its primary endpoint, demonstrating a 61% reduction in the risk of relapse versus placebo.
VYVGART Hytrulo offers a new weekly subcutaneous injection option, providing hope for patients grappling with severe mobility and sensory issues associated with CIDP.
argenx will present its 'Vision 2030: Taking Breakthrough Science to 50,000 Patients' on July 16, 2024, during its R&D Day in New York City.
The event will highlight recent Phase 2 data for Sjogren's disease and multifocal motor neuropathy, supporting their advancement to Phase 3.
However, development for efgartigimod in PC-POTS will not proceed due to lack of clinically meaningful results in Phase 2 studies.
argenx aims to transform the treatment landscape for autoimmune diseases with ongoing advancements in its pipeline, including VYVGART and empasiprubart.
Key agenda items include new pipeline candidates, leadership in FcRn, and broadening indications for myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
argenx, a global immunology company focused on severe autoimmune diseases, will participate in the Goldman Sachs 45th Annual Global Healthcare Conference on June 11, 2024, at 2:40 PM ET in Miami, FL. Management will engage in a fireside chat. The live webcast can be accessed via the argenx website, with a replay available for 90 days post-event.
argenx SE reported $398 million in first quarter global net product sales, with FDA review ongoing for CIDP sBLA and a PDUFA target action date of June 21, 2024. The company is on track to submit a filing for a pre-filled syringe in the second quarter of 2024. VYVGART SC played a significant role in driving growth, expanding prescriber base and reaching new patients. Multiple regulatory decisions are expected in 2024 for VYVGART and VYVGART SC, with plans for further expansion and development of the pipeline.
On May 7, 2024, argenx SE announced the results of its Annual General Meeting of shareholders. The meeting approved the annual report and accounts for the financial year ending December 31, 2023. Dr. Brian L. Kotzin was appointed as a non-executive director, while Peter Verhaeghe and Dr. Pamela Klein were re-appointed. The Board of Directors was authorized to issue shares and amend the articles of association. Deloitte Accountants B.V. and Ernst & Young Accountants LLP were appointed as auditors for the 2024 and 2025 financial years, respectively.
argenx, a global immunology company, will participate in a fireside chat at the BofA Securities 2024 Health Care Conference. The event will take place on May 14, 2024, in Las Vegas, NV, and will be live-streamed on the argenx website. This participation highlights the company's commitment to improving the lives of individuals with severe autoimmune diseases.
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