MannKind Corporation (NASDAQ:MNKD) is one of the best NASDAQ stocks to buy in 2026. On December 23, MannKind Corporation secured FDA approval for the FUROSCIX On-body Infusor to treat pediatric patients weighing 43 kg or more. This expands the treatment’s existing reach beyond adults with chronic heart failure/CHF and chronic kidney disease/CKD, providing a home-based option for managing fluid buildup/edema. Earlier on December 1, MannKind Corporation (NASDAQ:MNKD) announced that the US FDA accepted for ...

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].

Core Insights - MannKind Corporation reported a 17% increase in Q3 2025 revenues to $82.1 million compared to Q3 2024, driven by higher royalties and product sales [6][9][14] - The acquisition of scPharmaceuticals is expected to enhance MannKind's commercial capabilities and accelerate revenue growth [2][7] - The FDA has accepted the sBLA for Afrezza in the pediatric population, with a PDUFA date set for May 29, 2026 [6][7] Financial Performance - Q3 2025 revenues reached $82.1 million, a $12.1 million increase from Q3 2024, with royalties up 23% to $33.3 million and Afrezza sales up 23% to $18.5 million [9][12] - Year-to-date revenues for 2025 totaled $237.0 million, reflecting a 14% increase compared to the same period in 2024 [14] - The company reported a net income of $8.0 million for Q3 2025, down from $11.6 million in Q3 2024, while non-GAAP net income increased by 45% to $22.4 million [16][23] Business Developments - The acquisition of scPharmaceuticals was completed on October 7, 2025, which is anticipated to diversify and accelerate revenue growth, particularly through the FUROSCIX product [6][7] - The company initiated a Phase 2 clinical trial for MNKD-201 in idiopathic pulmonary fibrosis (IPF) and plans to enroll the first patient in Q1 2026 [5][6] - MannKind's MNKD-101 Phase 3 trial achieved interim enrollment targets ahead of schedule, with an interim analysis expected mid-year 2026 [6][7] Research and Development - Research and development expenses increased by 9% in Q3 2025, primarily due to ongoing clinical trials and patient enrollment [12][17] - The company is advancing its investigational molecule under collaboration with United Therapeutics and has planned pre-clinical studies for Bumetanide DPI [11][17] Cash and Investments - As of September 30, 2025, MannKind had cash, cash equivalents, and investments totaling $286.3 million, with significant cash utilized for the acquisition of scPharmaceuticals [11][12] - The company reported an impairment of available-for-sale investment of $6.4 million for Q3 2025 due to the write-off of the Thirona investment [16][23]