Seeking approval, MannKind stock jumps on FDA approval

MannKind Corporation (NASDAQ: MNKD) shares rose 6% Friday morning after the company announced FDA approval of Furoscix ReadyFlow and a $50 million private placement.

The FDA approved Furoscix ReadyFlow (furosemide injection) for the treatment of edema in adults with heart failure or chronic kidney disease. The autoinjector delivers an 80 mg/mL furosemide dose in under 10 seconds, with symptom relief potentially beginning in an hour or less.

Furoscix ReadyFlow is the first autoinjector delivering subcutaneous furosemide with IV-equivalent exposure based on comparisons of AUC and PD endpoints. The therapy is designed for self-administration outside hospital settings, providing an at-home treatment option for patients experiencing fluid overload.

The approval is supported by clinical data showing Furoscix ReadyFlow achieved its primary pharmacokinetic endpoint and demonstrated equivalent urine output, sodium excretion and potassium excretion at 6, 8 and 12 hours compared to IV furosemide. The product was generally well tolerated, with a safety profile consistent with oral and intravenous furosemide.