MannKind’s Strategic Acquisition Nears Key Regulatory Milestone

A significant regulatory milestone has been reached for MannKind Corporation following its acquisition of scPharmaceuticals. The U.S. Food and Drug Administration (FDA) has formally accepted for review an application for a new, patient-friendly delivery method of the heart failure drug FUROSCIX. This development represents a pivotal moment for the asset now under MannKind's umbrella.

The agency will review a Supplemental New Drug Application (sNDA) for the FUROSCIX ReadyFlow™ Autoinjector, officially initiating the evaluation process. A target decision date of July 26, 2026, has been set by the regulator.

The potential approval of the autoinjector promises a dramatic shift in how patients receive treatment. The currently approved FUROSCIX infusion pump requires an administration period of approximately five hours. In stark contrast, the ReadyFlow system is designed to deliver the injection in under ten seconds. This innovation could offer adults suffering from chronic heart failure or kidney disease a far more convenient option for managing fluid overload at home, potentially reducing the need for hospital admissions.

Should investors sell immediately? Or is it worth buying scPharmaceuticals?

The Acquisition's Foundation and Financials

This progress stems from MannKind's complete takeover of scPharmaceuticals, finalized on October 7, 2025. The transaction involved MannKind purchasing all outstanding shares for $5.35 per share in cash. Additionally, scPharmaceuticals shareholders received a non-tradeable Contingent Value Right (CVR), which could pay up to an additional $1.00 per share upon achieving specific regulatory and commercial milestones. scPharmaceuticals stock ceased trading upon the deal's completion.

Prior to the acquisition, scPharmaceuticals reported second-quarter 2025 net revenue for FUROSCIX of $16.0 million—a 99 percent increase compared to the same period the previous year. Despite this revenue growth, the company recorded a quarterly net loss of $18.0 million.

The next definitive checkpoint for the FUROSCIX portfolio is the FDA's July 26, 2026, decision deadline. Securing approval for the autoinjector would bolster MannKind's product offerings and reinforce its strategic expansion into the cardiometabolic disease sector.