MannKind Soars after FDA Approves Study Design

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Shares of MannKind Corp jumped Friday morning, a day after the biotech said the U.S. Food and Drug Administration approved the design of two clinical studies needed to answer lingering concerns about its experimental insulin inhaler Afrezza.

The Valencia company founded by billionaire Alfred Mann said Thursday night that the FDA confirmed protocols for two studies in which the device will be tested on patients with type 1 and type 2 diabetes. Afrezza is taken at the beginning of a meal and dissolves immediately upon inhalation to deliver insulin to the blood stream.

“Our attention now turns to the execution of these trials,” said Chief Executive Mann, who has pumped much of his own fortune into the company as the approval process dragged on. The company has previously said it did not expect the trials to be completed by 2012.

The FDA in January declined to approve the device, complaining that the company had updated the design of the inhaler itself without conducting updated trials about its safety and effectiveness. The second-generation inhaler, dubbed Dreamboat, is smaller than first-generation MedTone inhaler, and MannKind said it included other improvements.

JMP Securities on Friday upgraded Mannkind’s stock to “market outperform” and set a 12-month price target of $7 per share.

Shares were up 39 cents, or 16.5 percent, to $2.76 in midday trading on the Nasdaq after earlier rising as high as 33 percent.

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