(RTTNews) - MannKind Corp. (MNKD), a biopharmaceutical company, announced Friday that it received U.S. FDA approval for Furoscix ReadyFlow to treat edema in adults with heart failure or chronic kidney disease.
The FDA approval was supported by clinical results that showed Furoscix ReadyFlow met its primary pharmacokinetic endpoint, demonstrating intravenous-equivalent drug exposure.
The study also demonstrated comparable urine output, sodium excretion and potassium excretion at 6, 8 and 12 hours versus intravenous Furosemide. Furoscix ReadyFlow was generally well tolerated, with a safety profile consistent with oral and intravenous Furosemide.
MannKind expects to commercially launch Furoscix ReadyFlow autoinjector in the U.S. by the end of August 2026.
According to the company, the approval expands the Furoscix franchise with an at-home treatment option for adults with heart failure or chronic kidney disease experiencing fluid overload.
The previously approved Furoscix on-body infusor, which requires about five hours for administration, was approved by the FDA in 2022 for edema in adults with heart failure, with its label expanded in 2025 to include chronic kidney disease.
The approved autoinjector delivers an 80 mg dose of subcutaneous Furosemide in less than 10 seconds and provides IV-equivalent drug exposure based on pharmacokinetic and pharmacodynamic data. The company also said symptom relief may begin within an hour of administration.
Separately, Mannkind said it has entered into a securities purchase agreement with certain institutional investors in a private placement.
Under the agreement, Mannkind will issue 10.44 million shares of common stock at a price of $3.89 per share and pre-funded warrants to purchase up to 2.41 million shares priced at $3.88 per warrant. The warrants will have an exercise price of $0.01 per share and will remain exercisable until fully exercised.
Mannkind expects gross proceeds of $50 million, which it intends to fund general corporate purposes, along with funding the contingent value rights payment of $45 million, with respect to the FDA approval of Furoscix ReadyFlow.
The Frazier Life Sciences led financing is expected to close on or about July 24, 2026, subject to customary closing conditions.
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