MOUNTAIN VIEW, Calif., July 26, 2011 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq:ALXA - News) announced today that it will report financial results for the quarter ended June 30, 2011, on Monday, August 8, 2011, following the close of the U.S. financial markets. Alexza also announced that the resubmission of its AZ-004 New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) is now planned for Monday, August 8, 2011. The Company completed the writing of the NDA sections earlier this week. The documents have been transferred to Alexza's electronic submission vendor who is assembling and processing the files for eCTD (electronic Common Technical Document) submission to the FDA.
"The entire Alexza organization has worked diligently toward the resubmission of our AZ-004 NDA," said Thomas B. King, Alexza President and CEO. "Our employees have combined their skills with those of some outstanding outside consultants and advisors, who are experts in the key areas of focus of our resubmission. In addition to the data in our original NDA, our resubmitted NDA contains data from our successfully completed human factors study, stability data from new production batches manufactured late last year, and a comprehensive REMS proposal and draft labeling for AZ-004."
On Monday, August 8, at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time, the Company will host an investor conference call and live webcast to provide a company update, as well as to discuss the financial results. The conference call, live webcast and archived replay are open to all interested parties.
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