MannKind's SNDA For FUROSCIX ReadyFlow Autoinjector Accepted By FDA

(RTTNews) - MannKind Corporation (MNKD) on Monday announced that the FDA has accepted their supplemental NDA for the FUROSCIX ReadyFlow Autoinjector.

This device is meant to administer subcutaneous furosemide in less than 10 seconds. The application is set to be reviewed by July 26, 2026.

The ReadyFlow Autoinjector aims to provide adults with chronic heart failure or chronic kidney disease a quicker, at-home method to manage fluid buildup, reducing the time needed from five hours, as with the current On-body Infusor, to mere seconds.

This filing is supported by positive study findings, which demonstrate strong bioavailability and comparable clinical effects to IV furosemide.

MNKD is currently trading at $5.38 up $0.03 or 0.56 percent on the Nasdaq.