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].

Core Viewpoint - Nkarta, Inc. is focused on advancing its engineered natural killer (NK) cell therapy, NKX019, for the treatment of autoimmune diseases, while implementing a restructuring plan to enhance financial stability and extend its cash runway [2][4][12]. Financial Performance - For the full year 2024, Nkarta reported a net loss of $108.8 million, or $1.60 per share, compared to a net loss of $117.5 million in 2023 [12][19]. - The company had cash, cash equivalents, and investments totaling $380.5 million as of December 31, 2024, which is expected to fund operations into 2029 [4][12][19]. - Research and development expenses for 2024 were $96.7 million, while general and administrative expenses were $31.5 million [12][19]. Clinical Development - Nkarta is conducting two clinical trials, Ntrust-1 and Ntrust-2, to evaluate NKX019 in various autoimmune diseases, with initial data expected in the second half of 2025 [4][8]. - The Ntrust-1 trial focuses on lupus nephritis, while Ntrust-2 targets systemic sclerosis, idiopathic inflammatory myopathy, and ANCA-associated vasculitis [5][9]. - The dosing schedule for NKX019 has been harmonized across all trials, with patients receiving treatment on Days 0, 3, and 7 following lymphodepletion [10]. Restructuring Efforts - Nkarta has implemented a restructuring plan that includes a workforce reduction of 34% (53 positions) to prioritize investment in clinical execution and extend its cash runway [2][4][12]. - The restructuring is expected to result in cash payments of approximately $5.5 to $6.5 million [12]. Product Overview - NKX019 is an allogeneic, off-the-shelf CAR NK-cell therapy designed to target CD19-positive cells in autoimmune diseases, offering potential advantages such as rapid B-cell killing and reduced toxicity [2][7][14]. - The therapy is engineered for enhanced targeting and persistence, aiming to provide broad access in outpatient settings [14].