Welcome to our dedicated page for Argenx Se news (Ticker: ARGX), a resource for investors and traders seeking the latest updates and insights on Argenx Se stock.
argenx SE (ARGX) is a global immunology company listed on Euronext and Nasdaq that focuses on severe autoimmune diseases through antibody-based medicines. Its news flow centers on clinical data, regulatory milestones, commercial performance and strategic updates related to its FcRn-targeting medicine VYVGART and a broader pipeline of experimental antibodies.
Investors and healthcare observers following ARGX news can read about regulatory interactions such as the U.S. Food and Drug Administration’s acceptance for priority review of a supplemental Biologics License Application (sBLA) for VYVGART in acetylcholine receptor antibody seronegative generalized myasthenia gravis (gMG). Company announcements also cover Phase 3 trial readouts, including the ADAPT SERON study in seronegative gMG and other registrational programs across neuromuscular and autoimmune indications.
argenx regularly reports preliminary and quarterly financial results, highlighting global product net sales from the VYVGART franchise and outlining strategic priorities tied to its long-term "Vision 2030". News items describe the expansion of VYVGART and VYVGART Hytrulo across gMG, chronic inflammatory demyelinating polyneuropathy (CIDP) and immune thrombocytopenia (ITP) in certain regions, as well as progress with pipeline candidates such as empasiprubart and ARGX-119.
Corporate news includes leadership transitions, conference presentations at major medical and investor meetings, and updates from the company’s Immunology Innovation Program (IIP). For readers interested in ARGX stock and the evolution of its immunology franchise, this news feed provides a consolidated view of clinical, regulatory, commercial and corporate developments as disclosed in argenx press releases and related filings.
argenx (Euronext & Nasdaq: ARGX), a global immunology company, has announced its participation in three upcoming investor conferences in September 2024:
- 2024 Wells Fargo Healthcare Conference: Fireside chat on September 4 at 1:30 p.m. ET in Boston, MA
- Morgan Stanley 22nd Annual Global Healthcare Conference: Fireside chat on September 5 at 4:50 p.m. ET in New York, NY
- Baird 2024 Global Healthcare Conference: Fireside chat on September 10 at 9:40 a.m. ET in New York, NY
The company, which focuses on improving lives of people with severe autoimmune diseases, will have members of its management team present at these events. Additional information about these conferences will be available on the Investors section of the argenx website.
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.