MannKind Corporation (NASDAQ:MNKD) shares climbed around 6% on Friday after the biotechnology company announced U.S. Food and Drug Administration approval for its Furoscix ReadyFlow autoinjector and unveiled a $50 million private placement to strengthen its balance sheet.
The regulatory approval and accompanying financing marked a significant milestone as MannKind prepares to launch the treatment in the U.S. market.
FDA approves new at-home treatment for fluid overload
The FDA approved Furoscix ReadyFlow (furosemide injection) for the treatment of oedema in adults with heart failure or chronic kidney disease.
The device delivers an 80 mg/mL dose of furosemide via a subcutaneous autoinjector in less than 10 seconds, offering a faster and more convenient alternative to existing therapies designed for use outside hospital settings.
According to MannKind, patients may begin experiencing symptom relief within an hour of administration.
Clinical results support approval
MannKind said Furoscix ReadyFlow is the first subcutaneous autoinjector to provide intravenous-equivalent furosemide exposure based on pharmacokinetic and pharmacodynamic comparisons.
Clinical studies demonstrated that the treatment met its primary pharmacokinetic endpoint while producing comparable urine output, sodium excretion and potassium excretion at six, eight and 12 hours versus intravenous furosemide.
The company added that the treatment was generally well tolerated and demonstrated a safety profile consistent with both oral and intravenous formulations of furosemide.
Commercial availability in the United States is expected before the end of August.
Faster delivery aims to improve patient convenience
The new autoinjector significantly reduces treatment time compared with the currently available Furoscix on-body infusor.
While the existing device requires approximately five hours to administer a dose, ReadyFlow delivers treatment in 10 seconds or less, offering patients a more practical option for managing fluid overload at home.
Company raises $50 million through private placement
Alongside the FDA approval, MannKind announced a private placement with institutional investors led by Frazier Life Sciences.
The company agreed to sell 10,440,838 shares of common stock together with pre-funded warrants to purchase up to 2,412,632 additional shares.
The securities were priced at $3.89 per share and $3.88 per pre-funded warrant, with the transaction expected to generate gross proceeds of approximately $50 million.
MannKind said the proceeds will be used for general corporate purposes, including funding the $45 million contingent value rights payment triggered by the FDA approval of Furoscix ReadyFlow.
The financing is expected to close on or about July 24, subject to customary closing conditions.
MannKind Corporation stock price
