April 7 MannKind Corp said the U.S.
Food and Drug Administration extended the review date of its
inhaled insulin treatment by three months, sending the company's
shares down as much as 22 percent before the bell.
The news comes less than a week after an advisory panel to
the FDA recommended approving the treatment, Afrezza, but said
longer-term studies would be required to gauge the risk of lung
cancer and other potential side-effects.
MannKind said on Monday the new review date of July 15 was
set to give the FDA time to fully review information it had
Analysts had expected the FDA to delay its decision given
the concerns about Afrezza's safety and efficacy.
Afrezza consists of a whistle-sized inhaler designed to
deliver insulin powder to the lungs, making it more convenient
to use than conventional, injected insulin.
If approved, Afrezza would be the first inhaled insulin
treatment available in the United States since 2006.
MannKind's shares, which doubled the day after the panel's
recommendation, fell as much as 22 percent to $5.36 in premarket
trading on Monday.
(Reporting by Vrinda Manocha in Bangalore, Editing by Savio