MannKind Posts Strong 2025 Growth, Eyes FDA Decisions in 2026

Event summary

  • MannKind reported Q4 2025 revenues of $112M, up 46% YoY, driven by Furoscix and Afrezza sales.
  • Furoscix net sales surged 91% YoY to $23M post-acquisition of scPharmaceuticals.
  • Afrezza net sales increased 25% YoY to $23M, with pediatric indication PDUFA date set for May 29, 2026.
  • Full-year 2025 revenues reached $349M, up 22% YoY.
  • Furoscix ReadyFlow Autoinjector PDUFA date set for July 26, 2026.

The big picture

MannKind's strong 2025 performance reflects its strategic pivot towards cardiometabolic and orphan lung diseases, bolstered by the scPharmaceuticals acquisition. The company's focus on innovative drug-device combinations positions it to capitalize on regulatory milestones in 2026, potentially expanding its market reach in both adult and pediatric diabetes care. The ADA's endorsement of inhaled insulin could further accelerate Afrezza's adoption, while the Furoscix ReadyFlow Autoinjector aims to disrupt the diuretic market.

What we're watching

Regulatory Approvals
Whether the FDA will approve the pediatric indication for Afrezza and the Furoscix ReadyFlow Autoinjector by their respective PDUFA dates.
Commercial Execution
How MannKind will leverage the ADA's recommendation for inhaled insulin to drive broader adoption of Afrezza.
Pipeline Progress
The pace at which MannKind advances its Nintedanib DPI program and other development candidates.

Related topics

Acquisition