Argenx Se Stock Price, News & Analysis

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.

argenx, a global immunology company, will participate in a fireside chat at the BofA Securities 2024 Health Care Conference. The event will take place on May 14, 2024, in Las Vegas, NV, and will be live-streamed on the argenx website. This participation highlights the company's commitment to improving the lives of individuals with severe autoimmune diseases.

argenx, a global immunology company, will report its first quarter 2024 financial results and provide a business update on May 9, 2024. The company will host a conference call and webcast to discuss the results and future plans. Investors can access the webcast on the company's website. Dial-in numbers are provided for different countries.