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EX-99.1 - PRESS RELEASE - Alexza Pharmaceuticals Inc.d269369dex991.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): December 13, 2011

 

 

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 December 13, 2011, Alexza Pharmaceuticals, Inc. announced that the Psychopharmacologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted to recommend that ADASUVE™ (Staccato® loxapine) be approved for use as a single dose in 24 hours when used with the FDA recommended Risk Evaluation and Mitigation Strategy, for the treatment for agitation in patients with schizophrenia or bipolar mania. 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 “FDA Psychopharmacologic Drugs Advisory Committee Recommends Approval of Alexza’s ADASUVE™,” dated December 13, 2011.


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: December 13, 2011      
   

By:

 

    /s/ August J. Moretti

     

August J. Moretti

Senior Vice President, Chief Financial Officer,

General Counsel and Secretary


INDEX TO EXHIBITS

 

Exhibit Number

 

Description

99.1   Press Release titled “FDA Psychopharmacologic Drugs Advisory Committee Recommends Approval of Alexza’s ADASUVE™,” dated December 13, 2011.