Argenx Se Stock Price, News & Analysis

argenx reported strong Q3 2024 financial results with global net product sales of $573 million for VYVGART. The company achieved a net profit of $91.4 million for Q3 2024, compared to a loss of $72.6 million in Q3 2023. Total operating income reached $589 million, with cash and equivalents of $3.4 billion as of September 30, 2024.

The company continues to expand globally with CIDP approvals under review in Japan, Europe, China, and Canada. VYVGART is now reimbursed in 11 European countries, with new agreements in France, Luxembourg, and Belgium. The company maintains its guidance of approximately $2 billion for combined selling, general and administrative expenses and research and development expenses.

argenx (Euronext & Nasdaq: ARGX), a global immunology company, has announced it will host a conference call and audio webcast on Thursday, October 31, 2024 at 1:30 PM CET (8:30 AM ET) to discuss its third quarter 2024 financial results and provide a business update. The webcast will be accessible through the Investors section of argenx's website, with a replay available for approximately one year. The company has provided international dial-in numbers for Belgium, France, Netherlands, United Kingdom, United States, Japan, and Switzerland.

argenx announced clinical and real-world data for its immunology pipeline at the 2024 AANEM Annual Meeting and MGFA Scientific Sessions. Key highlights include VYVGART® (efgartigimod alfa-fcab) and VYVGART® Hytrulo demonstrating rapid, deep, and sustained responses in generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART has shown a favorable safety profile with over 8,000 patient years of data, and more than 50% of gMG patients experienced a substantial reduction in steroid use. The company also reported progress in its neurology pipeline, including empasiprubart in MMN and ARGX-119 in ALS and CMS.

argenx SE (Nasdaq: ARGX) announced the publication of the ADHERE Study data in The Lancet Neurology, showcasing the efficacy of VYVGART Hytrulo in treating chronic inflammatory demyelinating polyneuropathy (CIDP). Key findings include:

- 61% reduction in relapse risk vs placebo
- 69% of patients showed clinical improvement
- Rapid onset of action (median 22 days)
- Well-tolerated safety profile

VYVGART Hytrulo, approved by the FDA in June 2024 for CIDP treatment, demonstrated reduced disease progression and relapse risk. The study, involving 322 patients, is the largest CIDP clinical trial to date, advancing scientific knowledge of the disease biology.

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.