MannKind (NASDAQ:MNKD) announced a major clinical milestone Monday, enrolling the first patient in its INHALE-1ST study just as it prepares for a transformative FDA decision that could introduce the first needle-free insulin for children in over a century.
The Danbury, Connecticut-based biotech has officially begun the INHALE-1ST trial, a single-arm study evaluating the early initiation of Afrezza (inhaled insulin) in youth aged 10 to 18 who are newly diagnosed with type 1 diabetes.
Unlike previous studies that focused on patients already accustomed to injections, this trial targets the "newly diagnosed" window to see if a needle-free mealtime option can improve the overwhelming transition to life with diabetes.
The study will monitor 100 patients across 10 U.S. sites, with a primary focus on achieving ≥70% time-in-range (70–180 mg/dL) "time-in-range" via continuous glucose monitoring (CGM).
The news comes as MannKind rides a wave of commercial momentum.
The company recently pre-announced a record-breaking fourth quarter of 2025, with net revenue exceeding $100 million for the first time.
This growth is being fueled by a dual-engine strategy: the steady 23% year-over-year rise in Afrezza sales and high-margin royalties from Tyvaso DPI®, the inhaled pulmonary hypertension treatment partnered with United Therapeutics.