MannKind Reports 46% Revenue Surge, Targets $450M+ with Afrezza Growth
MannKind reported $350 million revenue in 2025, a 46% increase, and projects over $450 million in 2026 driven by Afrezza pediatric expansion, FUROSCIX auto-injector and Tyvaso DPI royalties. The MNKD-201 inhaled nintedanib Phase 1 trial in IPF patients enrolled four subjects with Phase 2 slated for early Q2 funding completion.
1. 2025 Revenue Growth and 2026 Outlook
MannKind achieved $350 million in total revenue for 2025, reflecting a 46% year-over-year increase, and outlined a framework to exceed $450 million in 2026. Management cited drivers including Afrezza’s pediatric launch, potential FUROSCIX auto-injector approval and royalties from Tyvaso DPI.
2. Afrezza Pediatric Expansion and Trials
Afrezza’s pediatric PDUFA date is May 29, with the INHALE-1ST trial rolling out initial sites focused on insulin-naïve pediatric patients. The company is exploring a 2-unit cartridge for finer titration and emphasizing early glucose-lowering profile data to support broader adoption in pediatric endocrinology.
3. Inhaled Nintedanib (MNKD-201) Phase 1 Initiation
The MNKD-201 program, in development for six to seven years, launched a Phase 1 two-cohort trial in IPF patients in December. Four patients are enrolled and 10 are in screening, with completion of the first 12-person cohort expected in 30–45 days and a fully funded Phase 2 planned for early Q2.
4. FUROSCIX Hospital Adoption and Auto-Injector Plans
MannKind is advancing FUROSCIX hospital protocols to reduce IV Lasix admissions and is pursuing an auto-injector lifecycle extension. The company has invested in hospital channel engagement across quality, finance and pharmacy teams to drive broader clinical adoption.