argenx SE reports developments as a global immunology company developing and commercializing antibody-based medicines for severe autoimmune diseases. Its updates center on VYVGART (efgartigimod alfa-fcab) and VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc), including approved use in adult generalized myasthenia gravis and clinical and regulatory work across myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
Recurring announcements also cover product sales, business updates, presentations of neuromuscular data, and pipeline progress for candidates such as empasiprubart, a monoclonal antibody targeting complement factor C2, and adimanebart. Governance items include annual general meeting results, board appointments, and leadership transitions for the Euronext- and Nasdaq-listed foreign issuer.
argenx (Euronext & Nasdaq: ARGX), a global immunology company focused on severe autoimmune diseases, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. Tim Van Hauwermeiren, the company's CEO, will deliver a presentation on Monday, January 13, 2025 at 9:45 a.m. PT.
The presentation will be accessible through a live webcast on the Investors section of the argenx website (argenx.com/investors). A replay option will remain available on the company's website for approximately 30 days after the presentation.
argenx announced that Japan's MHLW has approved VYVDURA for adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The treatment is administered as a weekly 30-90 second subcutaneous injection that can be self-administered at home, making it the first FcRn blocker approved for CIDP treatment in Japan.
The approval is based on the ADHERE Study, which showed that 69% of VYVDURA-treated patients demonstrated clinical improvement, with a 61% reduction in relapse risk versus placebo. The study was the largest clinical trial for CIDP to date, with 99% of participants continuing in the extension phase.
This marks VYVDURA's third approved indication in Japan, following its earlier approval for generalized myasthenia gravis (gMG) in January 2024.
argenx (Euronext & Nasdaq: ARGX), a global immunology company, has announced its management team's participation in three major healthcare conferences this December. The schedule includes presentations at Citi's 2024 Global Healthcare Conference in Miami (December 3), the 7th Annual Evercore I&I HealthCONx Conference in Coral Gables (December 4), and Piper Sandler's 35th Annual Healthcare Conference in New York (December 5). All presentations will be fireside chats, with additional information available on the company's investor relations website.
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.
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.
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.
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.