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 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.
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.