The company submitted its lead inhaled insulin product for expanded FDA approval and secured $500 million in funding, it said.
First, the Danbury, Connecticut-based company announced that it submitted a supplemental Biologics License Application (sBLA) for Afrezza, its inhaled insulin product, in the pediatric population.
MannKind Director of Medical and Scientific Engagement Joanne Rinker, MS, RDN, BC-ADM, CDCES, LDN, FADCES, told Drug Delivery Business News at ADA 2025 that a submission was on the way for children and adolescents aged 4-17 years old. Further data shared at ADA found Afrezza both safe and effective in that age range.
Afrezza is a fast-acting insulin formulation delivered through an inhaler device. MannKind engineered the mechanical inhaler device to slowly bring powder into the lung. A small compartment opens for the insertion of the insulin cartridge, then the user closes it. The only other component is a mouthpiece for the sake of cleanliness. Then, the inhalation takes just two seconds. It requires no electronics or extra components.
The company expects a review acceptance decision early in the fourth quarter of 2025.
“The submission of our supplemental Biologics License Application (sBLA) for Afrezza in pediatric patients is a meaningful milestone for MannKind and people living with diabetes,” said Michael Castagna, CEO of MannKind Corporation.
Additional funding provides a significant boost for MannKind
MannKind also announced a strategic financing agreement with funds managed by Blackstone worth up to $500 million. The financing provides MannKind with non-dilutive capital to advance its short- and long-term growth strategies.
This senior secured credit facility includes a $75 million initial term loan funded at closing. It then has a $125 million delayed draw term loan available for the next 24 months. Finally, it features an additional $300 million uncommitted delayed draw term loan available at the mutual consent of MannKind and Blackstone.
The facility bears interest at a calculated SOFR variable rate plus 4.75% and matures in August 2030.
“This strategic financing significantly increases our operating flexibility and provides us substantial access to non-dilutive capital on favorable terms, complementing our strong cash position,” said Castagna. “The funding will support the expansion of our commercial team in preparation for the anticipated launch of the pediatric indication for Afrezza, if approved, continued pipeline advancement, potential business development opportunities, and general corporate purposes. Partnering with the Blackstone team on this transaction positions us to accelerate our next phase of growth and innovation.”
