MannKind Corporation (NASDAQ:MNKD) are trading lower Monday. The company released its six-month results from its Phase 3 INHALE-1 pediatric diabetes trial. Here's what you need to know.
What To Know: The trial investigated the use of Afrezza (insulin human) Inhalation Powder in children and adolescents aged 4 to 17 years. Its primary endpoint was a non-inferior change in HbA1c levels after 26 weeks of treatment.
The results showed that, while Afrezza met the non-inferiority criteria based on a modified intent-to-treat (mITT) analysis, a full intent-to-treat (ITT) analysis did not meet the predetermined non-inferiority margin, largely due to the variability introduced by one non-compliant patient. Despite this, the mITT analysis supported Afrezza's non-inferiority to multiple daily injections (MDI) of rapid-acting insulin.
The study also showed no significant differences in lung function between the Afrezza and MDI groups, with both treatment groups maintaining stable FEV1 levels over the 26-week period. No major safety concerns, including hypoglycemia, were noted between the two treatment regimens.
Despite the encouraging efficacy and safety outcomes, the stock's decline reflects investor cautiousness, as the company now plans to meet with the U.S. Food and Drug Administration (FDA) in the first half of 2025 regarding a supplemental new drug application (sNDA) for Afrezza's use in pediatric populations. This meeting is crucial for the potential next steps in expanding the treatment's approval, which may contribute to further volatility in the stock price depending on the regulatory response.
MNKD Price Action: MannKind shares were down 4.28% at $6.27 at the time of writing, according to Benzinga Pro.
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