VYVGART® SC, first-and-only IgG Fc-antibody fragment which specifically targets the neonatal Fc receptor (FcRn), now approved for use in Europe for CIDPApproval based on ADHERE clinical trial, the largest study of CIDP patients to dateFirst novel mechanism of action for CIDP treatment in more than 30 years June 20, 2025, 7:00 PM CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseas ...

15 May 2025 | 12:57AM HKT China Healthcare Pulse Biotech led valuation re-rating YTD; eyeing on inflection for domestic recovery As we note earlier (Feb 25 and Nov 24), a recovery for China healthcare is underway, with improving investor sentiment and bottoming valuation. China offshore HC saw a pickup at +21% YTD, vs MXCN +12% and is now trading at 15x, 36%tile over last 5y. The YTD strong performance of Biotech (+37%) was driven by licensing-out theme and relative resilience to geopolitical uncertainty, w ...

ALKIVIA data demonstrate significant improvement in muscle strength and physical function in myositis patients treated with efgartigimodRHO data show efgartigimod achieved sustained reduction in autoantibodies and improved functional outcomes in patients with Sjogren’s disease; program granted U.S. FDA Fast Track designationargenx committed to new therapeutic areas in rheumatology with ongoing Phase 3 studies in myositis (ALKIVIA) and Sjogren’s disease (UNITY) June 11, 2025, 12:01 AM CET Amsterdam, the Net ...

Dianthus Therapeutics (DNTH) 2025 Conference June 05, 2025 09:55 AM ET Speaker0 Good morning, everybody. I'm Marino Garcia, CEO for Dianthus. I will be providing a brief update. Oh, here we go. Maury. How you doing? And then we'll open it up for some Q and A. Before I begin, just again, thank you to Jeffries for this opportunity today. I will be making some forward looking statements, so I urge everyone please to go to our website and where you can read all our SEC filings. This is a very exciting time for ...

Core Insights - argenx SE reported $790 million in global product net sales for the first quarter of 2025, marking a 99% increase year-over-year from $398 million in Q1 2024 [4][22] - The company is advancing its "Vision 2030" strategy, aiming to treat 50,000 patients across 10 labeled indications and to progress 10 Phase 2 and 10 Phase 3 studies [2][3] - The recent approval of the VYVGART-SC pre-filled syringe for self-injection in the U.S. and EU is expected to enhance patient access and treatment adoption [4][5] Financial Performance - Total operating income for Q1 2025 was $807 million, up from $413 million in Q1 2024 [15] - Total operating expenses increased to $668 million in Q1 2025 from $506 million in Q1 2024, primarily due to higher research and development costs [16][22] - The company reported a profit of $169 million for Q1 2025, compared to a loss of $62 million in the same period of 2024, resulting in a profit per share of $2.78 [19][22] Product Development and Pipeline - Efgartigimod is being evaluated in 15 severe autoimmune diseases, with ongoing studies in multiple therapeutic areas [6] - Empasiprubart is in registrational studies for multifocal motor neuropathy and CIDP, with proof-of-concept studies in delayed graft function and dermatomyositis [7] - ARGX-119 is being studied for congenital myasthenic syndromes, amyotrophic lateral sclerosis, and spinal muscular atrophy [8] Regulatory and Market Expansion - The company received a positive opinion from the CHMP for VYVGART-SC in the EU, with further approvals expected in Japan and Canada by the end of 2025 [4][5] - The launch of the VYVGART-SC pre-filled syringe is anticipated to support growth in both generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy [4][5] - Ongoing studies aim to expand treatment options for broader patient populations, including seronegative, ocular, and pediatric myasthenia gravis [4][5] Future Outlook - argenx plans to execute 10 registrational and 10 proof-of-concept studies across its pipeline candidates, with key insights expected from various studies by the end of 2025 and into 2026 [2][29] - The company continues to invest in its Immunology Innovation Program, with four new pipeline candidates nominated for development [12][29] - Financial guidance for combined selling, general and administrative expenses and research and development expenses remains unchanged at approximately $2.5 billion [20]

Core Insights - Halozyme Therapeutics, Inc. announced that argenx received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending European Commission (EC) approval of VYVGART® 1000mg for treating chronic inflammatory demyelinating polyneuropathy (CIDP) [1][4] - VYVGART® is the first targeted IgG Fc-antibody fragment for CIDP and represents the first novel mechanism of action for CIDP treatment in over 30 years [2] - The CHMP recommendation is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date [4] Company Overview - Halozyme is a biopharmaceutical company focused on improving patient experiences and outcomes through its ENHANZE® drug delivery technology, which facilitates subcutaneous delivery of injected drugs [5] - The company has licensed its ENHANZE® technology to major pharmaceutical companies including Roche, Takeda, and Pfizer, impacting over one million patients globally [5] - Halozyme also develops drug-device combination products aimed at enhancing patient comfort and adherence [6] Market Implications - The EC decision on the marketing authorization application is expected within approximately two months, which will apply to all 27 EU Member States and additional countries [1][4] - The approval of VYVGART® could provide a groundbreaking treatment option for patients with rare autoimmune diseases across Europe [3]

Core Viewpoint - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of VYVGART® (efgartigimod alfa) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in adult patients, marking a significant advancement in treatment options for this rare autoimmune disease [1][4]. Company Overview - argenx SE is a global immunology company focused on developing innovative treatments for severe autoimmune diseases, aiming to address significant unmet medical needs [2][9]. - The company has developed VYVGART, the first targeted IgG Fc-antibody fragment for CIDP, which, if approved, would be the first novel treatment for CIDP in Europe in over 30 years [2][5]. Clinical Trial Insights - The CHMP recommendation is based on positive results from the ADHERE clinical trial, which is the largest study of CIDP patients to date, involving 322 participants [3][5]. - In the ADHERE trial, 66.5% of patients treated with VYVGART showed clinical improvement, with a primary endpoint met demonstrating a 61% reduction in the risk of relapse compared to placebo [3][5]. - The trial also indicated significant functional improvements in various clinical assessment tools, with 99% of participants opting to continue in the open-label extension of the study [3][5]. Market Implications - The CHMP's positive opinion serves as a scientific recommendation for marketing authorization, with the European Commission expected to make a decision within approximately two months [4][5]. - If approved, VYVGART will be available for subcutaneous injection, providing a new treatment option for CIDP patients across all 27 EU member states, as well as Iceland, Norway, and Liechtenstein [4][5]. Disease Context - CIDP is a rare autoimmune disease affecting the peripheral nervous system, leading to symptoms such as fatigue, muscle weakness, and loss of sensation, which can significantly impair daily functioning [7]. - There are an estimated 31,413 individuals living with CIDP in the European Union, highlighting the need for effective treatment options [7].