In early April the FDA said it would delay its decision for three months and MannKind’s stock lost 11%, dropping to around $6.15. That FDA decision followed by one week the revelation that regulators had voted nearly unanimously to approve the drug for both Type 1 and Type 2 diabetes. That news sent the stock up 80% to around $7.25.
In Friday’s announcement an FDA official noted:
Afrezza is a new treatment option for patients with diabetes requiring mealtime insulin. Today’s approval broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels.
The FDA also noted that Afrezza is not a substitute for long-acting insulin. It must be used in combination with long-acting insulin in patients with type 1 diabetes. The drug is not recommended for the treatment of diabetic ketoacidosis, or in patients who smoke.
Shares traded more than 10% higher in after-hours trading on Friday and opened Monday morning up about 11.5% to post a new 52-week high of $11.48. In early trading, shares traded at $11.18, in a 52-week range of $3.80 to $11.48.
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