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Alexza says FDA extends review, shares fall 15%

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Alexza Pharmaceuticals (NASDAQ:ALXA) reported Monday that US health regulators extended the review date for the Adasuve new drug application by three months, resulting its stock to plunge nearly 16 percent.

The Food and Drug Administration informed Alexza that its updated risk evaluation and mitigation strategy program has been designated as a major amendment, and pushed the review date for the new drug application to May instead of February.

Shares were in negative territory dropping about 15 percent to trade at 68 cents apiece today on the Nasdaq.

Earlier this month, the drug maker submitted the amendment to its application to address issues discussed in a regulatory advisory committee meeting on the Adasuve application in December.

Alexza's chief executive, Thomas King, said: "We continue to believe that we are on a pathway to gain approval of ADASUVE in the United States."

"We appreciate the efforts of the FDA to complete their review of our NDA and we will continue to support the continued review of the NDA."

Adasuve, which is Alexza’s lead program, is being developed for the acute treatment of agitation in adults with schizophrenia, or bipolar disorder.

The drug combines Alexza’s staccato system – which is a hand-held single dose inhaler that delivers a medication comparable to intravenous administration – with loxapine an antipsychotic available in the US for those with schizophrenia. 

Alexza Pharmaceuticals, a development stage company, focuses on the research, development and commercialization of novel proprietary products for the acute treatment of central nervous system conditions.

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NASDAQ:ALXA
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