MannKind Corporation received FDA approval for its FUROSCIX® On‑body Infusor in pediatric patients weighing 43 kg or more, extending the drug’s use beyond the adult chronic heart failure and chronic kidney disease populations. The approval fulfills the Pediatric Research Equity Act requirements and opens a new market segment that was previously inaccessible to the company’s cardiorenal portfolio.
The pediatric approval is expected to add a significant revenue stream. FY 2025 year‑to‑date FUROSCIX revenue reached $47.1 million, a 95 % increase over the same period in 2024, and the company dispensed more than 27,000 doses in Q3 2025, up 153 % from the prior year. The approval is therefore a key driver of the record $82 million Q3 2025 revenue, which was 17 % higher than the prior year and largely powered by strong demand for FUROSCIX in both adult and pediatric indications.
In addition to the regulatory milestone, the U.S. Patent and Trademark Office granted five new patents covering the high‑concentration liquid formulation of furosemide and methods of treatment with the FUROSCIX ReadyFlow Autoinjector. The patents, which are expected to be listed in the FDA Orange Book if the autoinjector receives approval, provide protection through 2040 and reinforce MannKind’s intellectual‑property position for the drug‑device combination.
The pediatric approval comes on the heels of MannKind’s August 2025 acquisition of scPharmaceuticals, which added FUROSCIX to its cardiorenal lineup and positioned the company to pursue the ReadyFlow autoinjector. The autoinjector, still under FDA review with a PDUFA target of July 26 2026, could deliver an IV‑equivalent dose in under 10 seconds and would further expand home‑based treatment options for patients with heart failure or kidney disease.
Chief Medical Officer Dr. Ajay Ahuja said the approval “provides a convenient, home‑based option for pediatric patients who meet the weight criteria, reducing the need for hospital visits.” Analysts noted that the approval, combined with the pending autoinjector and the company’s strong Q3 performance, underpinned a positive market reaction, with investors citing the expanded addressable market and robust IP portfolio as key tailwinds.
The pediatric indication, coupled with the new patents and the pending autoinjector, positions MannKind to diversify its revenue base and capture a broader share of the cardiorenal market. The company’s strategy to leverage its Technosphere platform across multiple therapeutic areas is reinforced by these developments, signaling a continued focus on innovative drug delivery technologies and a commitment to expanding treatment options for patients with chronic conditions.
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