BOSTON (Reuters) - MannKind Corp said U.S. regulators need an additional four weeks to complete their review of its experimental diabetes treatment, lifting the hopes of some investors who had expected the drug to be rejected outright and sending the company's stock up 6.4 percent in premarket trading.
The Valencia, California-based company said it was informed on Monday that the U.S. Food and Drug Administration would not make a decision on whether to approve the product, a whistle-sized inhaled insulin device, by its December 29 deadline.
MannKind, whose founder and biggest shareholder is Alfred Mann, an 85-year-old entrepreneur who made his fortune developing solar cells, insulin pumps and implantable technology to help hearing, has plenty of detractors.
As of November 30, roughly 24 percent of the company's regularly traded shares were held "short" by investors betting the stock will fall.
The device, known as Afrezza, has already been turned back once by the FDA, which said in March it would not approve the product until it had received more information. The company believes it has provided that information.
In July, the FDA accepted a resubmission on the product, and it was due to make its decision by Wednesday.
MannKind's shares rose 6.4 percent to $8.48 in premarket electronic trading.
(Reporting by Toni Clarke and Esha Dey, editing by Dave Zimmerman)
