FDA approves MannKind's Afrezza to treat diabetes

In a much awaited decision, the US Food and Drug Administration on Friday approved MannKind Corp’s (Nasdaq: MNKD) Afrezza (insulin human [rDNA origin]) Inhalation Powder, a rapid-acting inhaled insulin to improve glycemic control in adults with diabetes mellitus. The news on Friday sent the stock rocketing 80% to around $7.25.

Stock prices normally rise on positive FDA decisions, but not in this case. MannKind’s shares plunged by as much as 20% at one point, before recovering some of those losses, down more than 5% to $10 and then adding 10% to $11 in extended trading.

Afrezza is a rapid-acting inhaled insulin that is administered at the beginning of each meal, or within 20 minutes after starting a meal. It acts more rapidly than injectable insulins such as Eli Lilly’s Humalog and Novo Nordisk's NovoLog. MannKind has taken almost eight years seeking approval of Afrezza since starting late-stage clinical trials, and has cost the company about $18 billion and two previous rejections by the FDA, the last in 2011