* Says FDA will not be able to complete review by Dec. 29
* Says FDA requires about 4 more weeks to complete review
* Shares rise as much as 11.5 percent
(Adds analyst comment, updates share price)
By Toni Clarke
BOSTON, Dec 28 MannKind Corp (MNKD.O) 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 expected the drug to be rejected
outright and sending the company's stock up as much as 11.5
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 Dec. 29
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 Nov. 30, roughly 24 percent of the company's
regularly traded shares were held "short" by investors betting
the stock would 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 resubmitted application, and it
was due to make its decision by Wednesday.
Analysts said the delay was difficult to interpret.
"The bull case: The delay means that the FDA is taking
MannKind's application seriously," said Avik Roy, an analyst at
Monness Crespi Hardt. "The bear case: The FDA doesn't consider
the Afrezza application to be urgent."
Michael Tong, an analyst at Wells Fargo Securities, said
that the delay should be viewed as a "generally neutral
"Additional approval delays could become problematic but we
think MannKind should be able to fund operations through 2011
with cash and credit currently available."
MannKind's shares were up 7.5 percent at $8.57 in morning
trading on Nasdaq after hitting $8.89 earlier in the session.
(Additional reporting by Esha Dey, editing by Dave Zimmerman)