MannKind Shares FUROSCIX® Business Updates

Core Viewpoint - MannKind Corporation has announced significant updates regarding the FUROSCIX product line, including the approval of the FUROSCIX On-body Infusor for pediatric patients and the issuance of new patents for the FUROSCIX ReadyFlow Autoinjector, which is currently under FDA review [1][4]. Group 1: Product Approvals - The FDA has approved a supplemental New Drug Application (sNDA) for the FUROSCIX On-body Infusor, expanding its indication to pediatric patients weighing 43 kg or more [2]. - FUROSCIX was previously approved for adults with edema associated with chronic heart failure (CHF) and chronic kidney disease (CKD) [2][9]. - The approval fulfills all post-marketing requirements under the Pediatric Research Equity Act [2]. Group 2: Intellectual Property Protection - The U.S. Patent and Trademark Office (USPTO) has issued five new patents for the FUROSCIX ReadyFlow Autoinjector, which cover high-concentration liquid compositions of furosemide and associated treatment methods potentially through 2040 [4]. - These patents enhance MannKind's intellectual property position and will be listed in the FDA's Orange Book if the autoinjector is approved [4][5]. Group 3: Potential Impact of New Products - The FUROSCIX ReadyFlow Autoinjector, if approved, could deliver an IV-equivalent diuretic dose in under 10 seconds, allowing patients to manage fluid buildup episodes at home [6][7]. - This innovation is expected to significantly reduce hospital visits, improve quality of life, and lower healthcare costs for patients, providers, and payers [8].