argenx SE American Depositary Shares - ARGX STOCK NEWS

Argenx announced the continuation of efgartigimod SC development in the Phase 2/3 ALKIVIA study for idiopathic inflammatory myopathies (IIM) following successful Phase 2 results. The study met its primary endpoint, showing statistically significant improvement in total improvement score (TIS) at Week 24 compared to placebo. The trial will continue enrolling patients across three myositis subtypes: immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and dermatomyositis (DM). The ALKIVIA study aims to enroll 240 patients total, with safety and tolerability profile consistent with previous clinical trials.

VYVGART Hytrulo has received NMPA approval in China for treating adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP), becoming the first and only approved therapy for this condition in the country. The treatment, administered as a weekly 30-to-90 second subcutaneous injection, demonstrated significant efficacy in clinical trials, showing a 69% reduction in relapse risk compared to placebo in Chinese participants. The approval was based on the ADHERE study results, where 78% of Chinese participants showed clinical improvement during the open-label period.

Zai Lab and argenx announced NMPA approval of VYVGART Hytrulo for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in China. This marks the first and only approved CIDP treatment in China, administered as a weekly 30-90 second subcutaneous injection. The approval is based on the ADHERE study, where Chinese participants showed a 69% reduction in relapse risk compared to placebo, with 78% demonstrating clinical improvement. The treatment addresses approximately 50,000 diagnosed CIDP patients in China, offering a new option beyond traditional corticosteroids and plasma-derived therapies.

argenx (Euronext & Nasdaq: ARGX), a global immunology company, has announced its management team's participation in two upcoming investor conferences in November 2024. The company will participate in a fireside chat at the Guggenheim Inaugural Healthcare Innovation Conference on November 12 at 2:30 p.m. ET in Boston, and attend investor meetings at the Jefferies London Healthcare Conference on November 20-21 in London. A live webcast of the Guggenheim fireside chat will be available on the company's website, with a replay accessible for approximately 90 days.

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.