Ahead of the Bell: MannKind shares soar

Shares of MannKind nearly doubled before markets opened Wednesday after FDA advisers voted unanimously to recommend approval of the drug Afrezza, a fast-acting insulin, for patients with the most common form of diabetes.

The committee's decision came more than three years after the Food and Drug Administration ordered MannKind to run more clinical studies on Afrezza. The FDA is expected to decide on MannKind's latest application by April 15.

The agency is not required to follow the recommendations of its advisers, but it usually does.

MannKind has no products on the market and lost more than $191 million last year.

Afrezza, an insulin powder, comes in a single-use cartridge and is designed to be inhaled at the start of a meal. MannKind said patients using the drug can achieve peak insulin levels within 12 to 15 minutes. That compares to a wait time of an hour and a half or more after patients inject insulin.

Late Tuesday, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 14-0 to recommend that Afrezza receive marketing approval to help adults with type 2 diabetes control their blood sugar levels. The committee also voted 13 to 1 to recommend that the insulin receive approval for adults with type 1 diabetes.

Diabetes is a chronic condition in which the body either does not make enough insulin to break down the sugar in foods or uses insulin inefficiently. It can lead to blindness, strokes, heart disease or death.

Demand for diabetes treatments are surging globally as the prevalence of obesity explodes.

In type 2 diabetes, the most common form of the disease, the body does not use insulin properly. Type 1 diabetes is usually diagnosed in children and young adults. In those cases, the body does not produce insulin.

Shares of MannKind Corp., based in is the Valencia, Calif., jumped 89 percent, or $3.57, to $7.59 less than an hour before markets opened Wednesday.