MannKind Corp

MannKind Corporation announced positive phase 3 data for Afrezza inhaled insulin in children and adolescents aged 4-17, meeting the primary endpoint of non-inferiority to multiple daily injections. The company plans to request an FDA meeting for a supplemental new drug application in the first half of 2025.

MannKind announced 6-month Phase 3 INHALE-1 study results of Afrezza in children/adolescents, showing non-inferiority to MDI for HbA1c change. No lung function differences noted. Plans for FDA sNDA meeting in 1H 2025.

MannKind's Phase 3 INHALE-1 study showed Afrezza (inhaled insulin) non-inferior to MDI in pediatric diabetes, with a 0.370% HbA1c change difference. No significant lung function or safety differences were observed. MannKind plans to meet FDA for a potential sNDA submission in 1H 2025.

MannKind announced 6-month results from its Phase 3 INHALE-1 study of Afrezza in children and adolescents, showing non-inferiority to MDI in HbA1c change. The company plans to meet with the FDA regarding an sNDA submission in 1H 2025. No significant differences in lung function or safety concerns were observed.

MannKind Corporation initiated its Phase 3 ICoN-1 clinical trial for Clofazimine Inhalation Suspension to treat NTM lung disease, with regulatory clearance in Australia, U.S., Japan, and South Korea, and Taiwan expected by year-end. The trial aims to enroll 230 participants at over 100 sites globally, with a presentation on the study planned for November 1 at the NTM Symposium Australia.

MannKind Corporation received clearance from Japan's PMDA to initiate Phase 3 study (ICoN-1) of Clofazimine Inhalation Suspension for NTM lung disease, with global study clearance in U.S., Japan, South Korea, and Australia, and expected clearance in Taiwan by 4Q 2024. The study aims to develop a potential therapy for NTM lung infections, with the first U.S. patient randomized in September 2024.