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WESTLAKE VILLAGE, Calif. - The U.S. Food and Drug Administration has accepted MannKind Corporation’s (NASDAQ:MNKD) supplemental biologics license application for Afrezza Inhalation Powder for pediatric patients with diabetes, the company announced Monday. The $1.5 billion market cap company, which InvestingPro analysis shows has achieved impressive 21.48% revenue growth over the last twelve months, continues to expand its innovative diabetes treatment portfolio.
The FDA assigned a Prescription Drug User Fee Act target action date of May 29, 2026, for the application, which seeks approval for Afrezza in children and adolescents aged 4-17 with type 1 or type 2 diabetes. Despite a recent 13.78% decline in share price over the past week, the company maintains strong fundamentals with a healthy 74.91% gross profit margin and solid liquidity, as indicated by a 2.5 current ratio.
If approved, Afrezza would become the first needle-free insulin option for pediatric patients since insulin therapy began over 100 years ago, according to the company’s press release.
The application is based on data from the Phase 3 INHALE-1 study, a 26-week open-label, randomized clinical trial that evaluated Afrezza in combination with basal insulin versus multiple daily injections with basal insulin in pediatric patients. The submission also included safety data from the study’s 26-week extension phase.
"Today’s milestone brings us one step closer to offering young children and teenagers living with diabetes a potential alternative therapy to multiple daily injections or an insulin pump system," said Dr. Kevin Kaiserman, Senior Vice President at MannKind Corporation.
Afrezza was first approved for adults in June 2014 and is currently available in the United States, India, and Brazil. The inhaled insulin product carries a boxed warning regarding the risk of acute bronchospasm in patients with chronic lung disease and is contraindicated in patients with asthma or COPD.
Full results from the INHALE-1 study will be presented at the International Society for Pediatric and Adolescent Diabetes conference in early November. According to InvestingPro, which offers comprehensive analysis and 12 additional expert tips for MNKD, the company’s overall financial health score is rated as GREAT, suggesting strong positioning for future growth opportunities. Discover detailed insights and expert analysis in the exclusive Pro Research Report, available to InvestingPro subscribers.
In other recent news, MannKind Corporation has completed its acquisition of scPharmaceuticals Inc. for $296.5 million. This acquisition adds FUROSCIX, a subcutaneous furosemide injection, to MannKind’s portfolio, which is used for treating edema in patients with chronic heart failure and kidney disease. Furthermore, MannKind has appointed Ajay Ahuja as its new Chief Medical Officer, who brings over two decades of biopharmaceutical experience to the company. In an analyst update, H.C. Wainwright has raised its price target for MannKind to $11, citing the success of Tyvaso in a clinical trial for idiopathic pulmonary fibrosis.
Additionally, MannKind has expanded its collaboration with United Therapeutics, receiving a $5 million upfront payment. This expanded agreement will see MannKind using its Technosphere platform to formulate a new investigational molecule, while United Therapeutics handles other development activities. These developments reflect MannKind’s strategic moves to enhance its product offerings and strengthen its leadership team.
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