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): February 11, 2010
ALEXZA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 000-51820 | 77-0567768 | ||
| (State or other jurisdiction | (Commission | (IRS Employer | ||
| of incorporation) | File Number) | 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 February 11, 2010, Alexza Pharmaceuticals, Inc. (“Alexza”) announced that the U.S. Food & Drug Administration has accepted the AZ-004 NDA for filing and has indicated a Prescription Drug User Fee Act (PDUFA) goal date of October 11, 2010. Alexza filed the AZ-004 NDA on December 11, 2009 and is seeking marketing approval for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder. The press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit Number | Description | |
| 99.1 | Press Release titled “Alexza Announces AZ-004 (Staccato® Loxapine) PDUFA Goal Date of October 11, 2010” dated February 11, 2010. |
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: February 11, 2010 | 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 AZ-004 (Staccato® Loxapine) PDUFA Goal Date of October 11, 2010” dated February 11, 2010. |