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): October 12, 2010 (October 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)) |
Section 8 — Other Events
Item 8.01. Other Events.
On October 11, 2010, Alexza Pharmaceuticals, Inc. issued a press release announcing that it has received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application (NDA) for AZ-004 (Staccato® loxapine), submitted as Adasuve™ Staccato® (loxapine) inhalation aerosol, 5 mg and 10 mg. The press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Section 9 — Financial Statements and Exhibits
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit Number | Description | |
| 99.1 | Press Release titled “Alexza Pharmaceuticals Receives Complete Response Letter for AZ-004 (Staccato® Loxapine) NDA” dated October 11, 2010. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Alexza Pharmaceuticals, Inc. | ||||
Date: October 12, 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 Pharmaceuticals Receives Complete Response Letter for AZ-004 (Staccato® Loxapine) NDA” dated October 11, 2010. |