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NEWS
MannKind Announces Six-Month Results From Phase 3 INHALE-1 Pediatric Diabetes Trial Utilizing Inhaled Insulin (Afrezza®)
4 minutes ago, 3:05 AM PST
Via GlobeNewswire
Company plans to meet with FDA regarding potential sNDA submission in 1H 2025
Call planned today at 8:30 a.m. (ET) to discuss company's diabetes program progression
4 minutes ago, 3:05 AM PST
Via GlobeNewswire
Company plans to meet with FDA regarding potential sNDA submission in 1H 2025
Call planned today at 8:30 a.m. (ET) to discuss company's diabetes program progression
MannKind (MNKD) announced six-month results from its Phase 3 INHALE-1 study of Afrezza (inhaled insulin) in children and adolescents aged 4-17 years. The 26-week trial involved 230 subjects randomized to either Afrezza or multiple daily injections (MDI) of rapid-acting insulin.
The modified intent-to-treat (mITT) analysis, excluding one non-adherent patient, demonstrated non-inferiority of Afrezza to MDI with a between-group difference of 0.370% in HbA1c change, meeting the primary endpoint's threshold of 0.4%. No significant differences in lung function or safety parameters were observed between groups.
The modified intent-to-treat (mITT) analysis, excluding one non-adherent patient, demonstrated non-inferiority of Afrezza to MDI with a between-group difference of 0.370% in HbA1c change, meeting the primary endpoint's threshold of 0.4%. No significant differences in lung function or safety parameters were observed between groups.
The company plans to meet with FDA regarding a potential supplemental new drug application (sNDA) submission in first half of 2025.
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