May 3 (Reuters) - Alexza Pharmaceuticals Inc said U.S. health regulators failed to approve its experimental treatment to calm patients with schizophrenia or bipolar disorder, sending its shares down as much as 43 percent in extended trade.
This is the second time that the U.S. Food and Drug Administration declined to approve the drug Adasuve, after the regulator issued another complete response letter in October 2010, citing breathing-related side effects.
On Thursday, the FDA said it found certain deficiencies at the company’s Mountain View, California manufacturing facility during an inspection.
Alexza said it believes the deficiencies are medical device specific and are readily addressable. It said it hopes to meet with the FDA soon to resolve these issues.
Shares of the company were trading down at 38 cents, after closing at 61 cents on Thursday on the Nasdaq.