Afrezza ADA 2026 Announcement Highlights Pediatric, Pregnancy, and AID Data

Key Takeaways

• Four Afrezza analyses are slated for ADA 2026 across youth diabetes, gestational diabetes, and automated insulin delivery use.
• The pediatric work draws from INHALE-1, comparing inhaled insulin with rapid-acting analogs in youth with baseline HbA1c at or below 9.5%, while the pregnancy item uses a randomized crossover design.
• The youth post hoc analysis uses a validated teen and parent survey among participants who reached HbA1c below 8% at 26 weeks, and the AID evaluation is exploratory and focused on total daily dose.

MannKind announced Afrezza-related presentations at ADA 2026 and said new clinical and real-world data will be presented across a broader program of nine posters. Four highlighted analyses focus on pediatric efficacy and A1c, youth treatment satisfaction, automated insulin delivery algorithm use, and a gestational diabetes comparison. The company also said FDA accepted a supplemental biologics license application for children and adolescents aged 4 to 17 with type 1 or type 2 diabetes. A May 29, 2026, target action date accompanies those scheduled ADA presentations, while pediatric review remains in progress.

One pediatric poster is a subgroup analysis from INHALE-1 comparing inhaled Technosphere insulin with rapid-acting analogs in children and adolescents whose baseline HbA1c was 9.5% or lower. MannKind said the presentation centers on pediatric efficacy and A1c, with 26-week A1c change and continuous glucose monitoring metrics included in the outcomes language. A separate post hoc INHALE-1 analysis focuses on treatment satisfaction among youth who achieved HbA1c below 8% at 26 weeks, using a validated teen and parent survey. The ADA listings present these as a youth efficacy and safety subgroup analysis and a youth satisfaction presentation rather than full result reports.

An exploratory analysis examines inhaled Technosphere insulin used with automated insulin delivery systems. Investigators plan to evaluate how different total daily dose algorithms may affect glycemic outcomes when inhaled insulin is used for prandial and correction dosing. The poster schedule places sessions on June 6, 7, and 8, with late-breaking comparative data listed for June 7. In MannKind's announcement, the automated insulin delivery presentation remains an exploratory evaluation rather than a performance readout.

The pregnancy-related presentation in the ADA poster program is described as a randomized crossover comparison of inhaled Technosphere insulin and rapid-acting analog insulin in gestational diabetes. The study is scheduled under controlled meal conditions, which the company identified as the setting for the comparative assessment. Named endpoints are postprandial glucose responses and hypoglycemia outcomes, without additional dataset details in the announcement. MannKind's ADA preview identifies pregnancy, pediatric care, and automated insulin delivery integration as the main clinical settings for the planned Afrezza presentations.

The ADA Scientific Sessions are scheduled for June 5 through 8, 2026, in New Orleans, and the company provided poster titles, presenter names, and booth information. Booth 909 is listed in the exhibit hall materials alongside the poster schedule and presenter lineup. Pediatric regulatory review also remains in progress after FDA acceptance of the supplemental application described by the company earlier in the announcement. The notice previews what is planned for ADA rather than disclosing the full poster datasets.