Attached files
| file | filename |
|---|---|
| EX-99.1 - PRESS RELEASE - Alexza Pharmaceuticals Inc. | d377019dex991.htm |
UNITED STATES
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
Date of Report (Date of earliest event reported): July 5, 2012
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):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | 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 July 5, 2012, Alexza Pharmaceuticals, Inc. (the “Company”) announced that the U.S. Food & Drug Administration (the “FDA”) has accepted the Company’s resubmitted ADASUVE New Drug Application as a complete, class 2 response to the FDA’s action letter, with an indicated Prescription Drug User Fee Act goal date of December 21, 2012. The press release is furnished as Exhibit 99.1 hereto, the contents of which are incorporated herein by reference.
Section 9 — Financial Statements and Exhibits
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit |
Description | |
| 99.1 | Press Release titled “Alexza Announces Adasuve™ (Staccato® Loxapine) PDUFA Goal Date of December 21, 2012,” dated July 5, 2012. | |
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: July 5, 2012 | ||||
| By: | /s/ Mark K. Oki | |||
| Mark K. Oki | ||||
| Vice President, Finance, Controller, and Secretary Principal Financial and Accounting Officer | ||||
INDEX TO EXHIBITS
| Exhibit |
Description | |
| 99.1 | Press Release titled “Alexza Announces Adasuve™ (Staccato® Loxapine) PDUFA Goal Date of December 21, 2012,” dated July 5, 2012. | |