Navigation Links
Alexza to Announce 2011 Second Quarter Financial Results on Monday, August 8, 2011
Date:7/26/2011

MOUNTAIN VIEW, Calif., July 26, 2011 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) 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.

To access the conference call via the Internet, go to www.alexza.com, under the "Investor Relations" link.  Please join the call at least 15 minutes prior to the start of the call to ensure time for any software downloads that may be required.  Interested parties may also pre-register to avoid pre-call delays at https://www.theconferencingservice.com/prereg/key.process?key=P844VRMWL.

To access the live conference call via phone, dial 888-713-4213.  International callers may access the live call by dialing +1-617-213-4865.  The reference number to enter the call is 68061440.

The replay of the conference call may be accessed via the Internet, at www.alexza.com, or via phone at 888-286-8010 for domestic callers or +1-617-801-6888 for international callers.  The reference number for the replay of the call is 14135984.  A replay of the call will be available for two weeks following the event.

About Alexza Pharmaceuticals, Inc.

Alexza is a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions.  Alexza's technology, the Staccato® system, vaporizes unformulated drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation.  The drug is quickly absorbed through the lungs into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous administration, but with greater ease, patient comfort and convenience. (Click here to see an animation of how the Staccato system works.)

AZ-004 (Staccato loxapine) is Alexza's lead program, which is being developed for the rapid treatment of agitation in schizophrenic or bipolar disorder patients.  Alexza has completed and announced positive results from both of its AZ-004 Phase 3 clinical trials and submitted the AZ-004 NDA in December 2009.  In October 2010, the Company received a Complete Response Letter, or CRL, from the FDA, regarding its NDA for AZ-004.  A CRL is issued by FDA's Center for Drug Evaluation and Research indicating that the NDA review cycle is complete and the application is not ready for approval in its present form.  The Company completed an end-of-review meeting with the FDA in late December 2010 and a Risk Evaluation and Mitigation Strategy (REMS) guidance meeting with the FDA in April 2011.  

For more information about Alexza, the Staccato technology or the Company's development programs, please visit www.alexza.com.

Safe Harbor Statement

The anticipated news release and conference call will contain forward-looking statements that involve significant risks and uncertainties. Any statement describing the Company's expectations or beliefs is a forward-looking statement, as defined in the Private Securities Litigation Reform Act of 1995, and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of developing and commercializing drugs, including the adequacy of the Company's capital to support the Company's current operations, the potential of the Company's planned AZ-004 NDA resubmission to adequately address the issues in the CRL, the eventual prospects that AZ-004 will be approved for marketing and the timing of the Company's resubmission of the AZ-004 NDA to the FDA. The Company's forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning Alexza's business are described in additional detail in the Company's Annual Report on Form 10-K for the year ended December 31, 2010, and the Company's other Periodic and Current Reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.


'/>"/>
SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Alexza Reports 2011 First Quarter Financial Results and Provides Business Update
2. Alexza to Present at the MDB Bright Lights Conference 2011
3. Alexza Prices $16.1 Million Registered Direct Offering
4. Alexza Reports 2010 Fourth Quarter and Full Year Financial Results and Provides General Corporate Update
5. Alexza to Announce 2010 Year-End Financial Results on Tuesday, March 15, 2011
6. Alexza Pharmaceuticals Completes End-of-Review Meeting With FDA for AZ-004 (Staccato® Loxapine) NDA
7. Alexza Pharmaceuticals Provides Regulatory Update for AZ-004 (Staccato® Loxapine)
8. Alexza Pharmaceuticals Reports 2010 Third Quarter Financial Results and Provides Business Update
9. Alexza Pharmaceuticals to Announce 2010 Third Quarter Financial Results on November 9, 2010
10. Alexza Pharmaceuticals Reacquires U.S. and Canadian Rights for AZ-004 (Staccato® Loxapine)
11. Valeant Pharmaceuticals Announces That Alexza Pharmaceuticals Has Received a Complete Response Letter for AZ-004 (Staccato® Loxapine) Inhalation Aerosol NDA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... June 24, 2016   Pulmatrix, Inc ., (NASDAQ: ... innovative inhaled drugs, announced today that it was added ... reconstituted its comprehensive set of U.S. and global ... is an important milestone for Pulmatrix," said Chief Executive ... awareness of our progress in developing drugs for crucial ...
(Date:6/23/2016)... Research and Markets has announced the addition of the ... report to their offering. ... failure, it replaces the function of kidneys by removing the ... the treatment helps to keep the patient body,s electrolytes such ... Increasing number of ESRD patients & substantial healthcare expenditure on ...
(Date:6/23/2016)... -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that ... PCT (procalcitonin) assay as a dedicated testing solution for ... clearance, Roche is the first IVD company in the ... risk assessment and management. PCT is a ... in blood can aid clinicians in assessing the risk ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... , ... Quality metrics are proliferating in cancer care, and are derived from ... of the beholder, according to experts who offered insights and commentary in the current ... For the full issue, click here . , For the American Society of ...
(Date:6/26/2016)... Birmingham, Lake Orion, Clarkston, Michigan (PRWEB) , ... ... ... their direction with respect to fertility once they have been diagnosed with endometriosis. ... for tolerable intercourse but they also require a comprehensive approach that can help ...
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding emergency ... its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. Ogunleye ... M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. Ogunleye ...
(Date:6/24/2016)... , ... June 24, 2016 , ... A recent ... most people are unfamiliar with. The article goes on to state that individuals are ... many of these less common operations such as calf and cheek reduction. The Los ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Global law ... magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this recognition are ... , Seven Greenberg Traurig Shareholders received special honors as members of this year’s Legal ...
Breaking Medicine News(10 mins):