FUROSCIX ReadyFlow Autoinjector (SCP-111)

July 24, 2026: MannKind Corporation (NASDAQ: MNKD) announced FDA approval of Furoscix ReadyFlow (furosemide injection) to treat edema (fluid overload) in adults with heart failure (HF) or chronic kidney disease (CKD). Furoscix ReadyFlow is a self-administered, ready-to-use autoinjector delivering subcutaneous furosemide with IV-equivalent exposure (based on AUC and pharmacodynamic comparisons), providing an 80 mg/mL dose in a single administration in under 10 seconds; symptom relief may begin in an hour or less.

Approval was supported by clinical data showing the product met its primary pharmacokinetic endpoint and demonstrated equivalent urine output, sodium excretion, and potassium excretion versus IV furosemide at 6, 8, and 12 hours. It was generally well tolerated with a safety profile consistent with oral and IV furosemide.

MannKind said Furoscix ReadyFlow is expected to be commercially available in the U.S. by end of August 2026, reducing administration time versus the currently available Furoscix on-body infusor (approved in HF in 2022 and CKD in 2025). A conference call/webcast is scheduled for July 24, 2026 at 9:00 a.m. ET to discuss the approval.