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EX-99.1 - PRESS RELEASE - Alexza Pharmaceuticals Inc.d371065dex991.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): June 22, 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 June 22, 2012, Alexza Pharmaceuticals, Inc. announced that it has resubmitted its ADASUVE New Drug Application to the U.S. Food and Drug Administration in response to a Complete Response Letter received in May 2012 and provided regulatory updates on US and EU submissions. 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 Number

  

Description

99.1    Press Release titled “Alexza Announces Resubmission of ADASUVE™ NDA and Provides Regulatory Updates on US and EU Submissions,” dated June 22, 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: June 22, 2012     By:    /s/ Mark K. Oki
      Mark K. Oki
     

Vice President, Finance, Controller, and Secretary

Principal Financial and Accounting Officer


INDEX TO EXHIBITS

 

Exhibit Number

  

Description

99.1    Press Release titled “Alexza Announces Resubmission of ADASUVE™ NDA and Provides Regulatory Updates on US and EU Submissions,” dated June 22, 2012.