UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 14, 2009
ALEXZA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 000-51820 | 77-0567768 | ||
| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||
| Alexza Pharmaceuticals, Inc. 2091 Stierlin Court Mountain View, California | 94043 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code:(650) 944-7000
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01. Other Events.
On December 14, 2009, Alexza Pharmaceuticals, Inc. (“Alexza”) announced that it has submitted its New Drug Application (“NDA”) for Staccato® loxapine (AZ-004) to the US Food and Drug Administration. The press release announcing the submission of the NDA and summarizing the results of the clinical trials for AZ-004 is furnished as Exhibit 99.1 hereto, the contents of which are incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit Number | Description | |
| 99.1 | Press Release titled “Alexza Announces Submission of AZ-004 (Staccato® Loxapine) NDA. Filing of the FirstStaccato-Based NDA Completed Ahead of Schedule” dated December 14, 2009. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Alexza Pharmaceuticals, Inc. | ||||
| Date: December 14, 2009 | By: | /s/ Thomas B. King | ||
| Thomas B. King | ||||
| President and Chief Executive Officer | ||||
INDEX TO EXHIBITS
| Exhibit Number | Description | |
| 99.1 | Press Release titled “Alexza Announces Submission of AZ-004 (Staccato® Loxapine) NDA. Filing of the FirstStaccato-Based NDA Completed Ahead of Schedule” dated December 14, 2009. |