Los Angeles Business Journal

MannKind Shares Fall on FDA Delay

By Business Journal Staff Monday, April 7, 2014

Shares of MannKind Corp. fell nearly 8 percent Monday after the company announced that the FDA’s final decision on its inhalable insulin could be delayed beyond an expected April 15 deadline.

The Valencia company said in a press release that the FDA had extended its decision date by three months to July 15 “in order to provide time for a full review of information submitted by MannKind in response to the FDA’s requests.”

The delay comes less than a week after an advisory panel recommended FDA approval of Afrezza, the company’s inhalable insulin product. The stock jumped 74 percent on April 2, the day after the panel’s recommendation.

However, an FDA staff report considered by the panel noted the drug’s potential risk of causing lung infections, bronchial spasms and coughing that caused some patients to stop treatment during clinical trials. Some believe that will prompt the FDA to attach a warning label to the drug.

Simos Simeonidis, an analyst at Cowen & Co. who covers MannKind, called the delay “not a major surprise” given all the data and feedback the agency must process, but he expects approval for Afrezza.

“After attending the panel last week, we came out with the view that the agency wants to make Afrezza available to patients, in great part because of what is viewed as a ‘real need’ for specific patient groups that may not be good candidates for injectable insulins, like patients not willing or able to use injectable insulins due to poor eyesight, lack of manual dexterity, being alone in their homes without a caregiver, needle-phobia, etc.,” he wrote in a note to investors.

Shares of MannKind closed down 54 cents, or 7.9 percent, to $6.33 on the Nasdaq. But they are still up 57 percent since the advisory panel’s recommendation.