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Prepared By R.R. Donnelley Financial -- Form 8-K
 
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):  12/19/2013
 
Dynavax Technologies Corporation
(Exact name of registrant as specified in its charter)
 
Commission File Number:  001-34207
 
Delaware
  
33-0728374
(State or other jurisdiction of
  
(IRS Employer
incorporation)
  
Identification No.)
 
2929 Seventh Street, Suite 100
Berkeley, CA 94710-2753
(Address of principal executive offices, including zip code)
 
(510) 848-5100
(Registrant’s telephone number, including area code)
 
(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:
[  ]   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))
 

 
Item 8.01.    Other Events
 
On December 19, 2013, we issued a press release titled "Dynavax Announces Submission of Responses to EMA Day 120 List of Questions for HEPLISAV(TM) MAA." A copy of the press release is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.
 
 
Item 9.01.    Financial Statements and Exhibits
 
(d) Exhibits.
The following exhibit is furnished herewith:

EX-99.1 Press Release, dated December 19, 2013, titled "Dynavax Announces Submission of Responses to EMA Day 120 List of Questions for HEPLISAV(TM) MAA".

 

 

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.
 
           
Dynavax Technologies Corporation
 
 
Date: December 19, 2013
     
By:
 
/s/    Michael Ostrach
               
Michael Ostrach
               
Vice President
 
 

 

EXHIBIT INDEX
 
Exhibit No.
  
Description
EX-99.1
  
Press Release, dated December 19, 2013, titled
Dynavax Technologies

Dynavax Technologies

2929 Seventh Street, Suite 100

Berkeley, CA 94710

Contact:

    

Michael Ostrach

    

Vice President and Chief Business Officer

510-665-7257

mostrach@dynavax.com

Dynavax Announces Submission of Responses to EMA Day 120 List of Questions for HEPLISAV™ MAA

BERKELEY, CA -- (Marketwired) -- 12/19/13 -- Dynavax Technologies Corporation (NASDAQ: DVAX) confirmed today that during the fourth quarter of 2013 it had submitted its responses to the Day 120 List of Questions issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding Dynavax's Marketing Authorization Application (MAA) for its HEPLISAV investigational adult hepatitis B vaccine.

Dynavax expects to receive the EMA Day 180 List of Outstanding Issues during the first quarter of 2014. 

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV.

About Dynavax

Dynavax, a clinical-stage biopharmaceutical company, discovers and develops novel vaccines and therapeutics in the areas of infectious and inflammatory diseases and oncology.  Dynavax's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine. For more information visit www.dynavax.com.