MannKind reports Q2 2026 results with pediatric Afrezza and Furoscix ReadyFlow approvals

MannKind Corporation reported second quarter 2026 results on August 5, 2026, highlighting regulatory and clinical progress across its pipeline. The company said it launched the pediatric indication of Afrezza following FDA approval, had the FUROSCIX ReadyFlow autoinjector approved for treatment of edema in HF and CKD, and reported positive nintedanib DPI Phase 1b data in IPF patients supporting continued Phase 2 advancement.¹

On Afrezza, the FDA approval covers use in children and adolescents ages 6 and older living with diabetes, granted May 29, 2026¹. MannKind also said it received a Breakthrough T1D grant to support "INHALE-1ST," described as a pediatric trial of Afrezza in youth with newly diagnosed type 1 diabetes¹.

For Furoscix, the FDA approved the ReadyFlow autoinjector on July 23, 2026, which the company described as the first and only autoinjector delivering IV-equivalent diuretic therapy for the treatment of edema in adults with heart failure (HF) or chronic kidney disease (CKD)¹, with commercial availability expected in late August.

In the fibrotic lung disease program, MannKind reported a topline data readout from the U.S. Phase 1b INFLO-1 study of nintedanib DPI (MNKD-201) demonstrating safety and tolerability in IPF patients, with site activation and enrollment now underway in the global Phase 2 INFLO-2 study.¹ Separately, ralinepag DPI (MNKD-1501) remains on track for an IND filing by year end¹, and MannKind received a $5 million payment from United Therapeutics to support advancement of ralinepag DPI¹.

On finances, the company reported cash, cash equivalents and investments of $111 million as of June 30, 2026¹, and said it closed a $50 million private placement on July 24, 2026, with proceeds intended to fund a $45 million CVR payment triggered by the FDA approval of Furoscix ReadyFlow.¹ Total revenues for the quarter were $109.4 million, up 43% versus Q2 2025¹.