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Alexza Pharmaceuticals 8-K 2012

Documents found in this filing:

  1. 8-K
  2. Ex-99.1
  3. Graphic
  4. Graphic
Form 8-K





Washington, D.C. 20549







Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 23, 2012 (January 20, 2012)




(Exact name of registrant as specified in its charter)




Delaware   000-51820   77-0567768

(State or other jurisdiction

of incorporation)



File Number)


(IRS Employer

Identification No.)

Alexza Pharmaceuticals, Inc.

2091 Stierlin Court
Mountain View, California

(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 January 23, 2012, Alexza Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (“FDA”) will require additional time to complete its review of the New Drug Application (“NDA”) for ADASUVE™ (Staccato® loxapine). In a notice received from the FDA, the Prescription Drug User Fee Act (“PDUFA”) date for the ADASUVE NDA has been extended from February 4, 2012, to May 4, 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 Number



99.1    Press Release titled “Alexza Announces Extension of the ADASUVE™ PDUFA Goal Date by Three Months,” dated January 23, 2012.


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.


Date: January 23, 2012      

/s/ Thomas B. King


Thomas B. King

President and Chief Executive Officer



Exhibit Number



99.1    Press Release titled “Alexza Announces Extension of the ADASUVE™ PDUFA Goal Date by Three Months,” dated January 23, 2012.
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