MNKD Stock Jumps On Receiving FDA Approval For Afrezza To Treat Diabetes In Children

• Afrezza is the only ultra-rapid-acting inhaled insulin approved by the FDA to improve glycemic control in children and adults.
• Approval is supported by results from the Phase 3 INHALE-1 study in pediatric patients.
• Eligible patients can access Afrezza today for $35 or less per month.

MannKind Corporation (MNKD) share price gained about 5% on Friday after the U.S. Food and Drug Administration approved the expanded use of Afrezza, making it the first and only needle-free, inhaled mealtime insulin available for children and adolescents living with diabetes. 

The approval allows children aged six and older with either type 1 or type 2 diabetes to manage their mealtime blood sugar levels via a portable inhaler. The regulatory milestone marks a major shift for pediatric patients, who have historically relied on subcutaneous injections or insulin pumps for insulin therapy.

"Mealtime insulin can be especially challenging for children because eating and snacking patterns, activity levels, and daily settings like school and sports often vary," said Desmond Schatz, a professor of pediatrics at the University of Florida College of Medicine, in a statement. "With its rapid onset and dosing at the start of a meal, Afrezza may help clinicians better match insulin therapy to how children and families live day to day."

MNKD Pediatric Study Data 

The FDA’s approval was heavily driven by data from MannKind's Phase 3 INHALE-1 clinical trial. The 26-week, open-label, randomized study evaluated the efficacy and safety of Afrezza in combination with basal insulin against multiple daily injections of rapid-acting analog insulin.

The trial enrolled 230 patients between the ages of 4 and 17, most of whom had type 1 diabetes. Results published in the journal Diabetes Care demonstrated that Afrezza met its primary endpoint of noninferiority in changing HbA1c levels compared to traditional injections.

Additionally, pediatric patients utilizing the inhaled treatment reported significantly higher satisfaction rates and experienced less weight gain than those in the injectable comparison group.

MNKD ‘Technosphere’ Technology 

Afrezza utilizes MannKind's proprietary Technosphere technology, which delivers human insulin powder deep into the lungs using a small, breath-powered inhaler.

According to clinical data, the drug dissolves immediately upon inhalation and enters the bloodstream within approximately one minute. The profile peaks between 35 and 45 minutes and returns to baseline within a few hours, closely mimicking the natural mealtime insulin response of a person without diabetes.

MNKD Retail View 

Retail sentiment on Stocktwits was “extremely bullish” with “high” message volumes. 

One user highlighted bullishness by saying other pharma companies would need to inquire about Technosphere. 

https://stocktwits.com/Playthegame06/message/654825272

MNKD stock has lost nearly 34% year-to-date. 

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