<SEC-DOCUMENT>0001181431-12-047129.txt : 20120823
<SEC-HEADER>0001181431-12-047129.hdr.sgml : 20120823
<ACCEPTANCE-DATETIME>20120823115234
ACCESSION NUMBER:		0001181431-12-047129
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20120822
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20120823
DATE AS OF CHANGE:		20120823

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			DYNAVAX TECHNOLOGIES CORP
		CENTRAL INDEX KEY:			0001029142
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				330728374
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-34207
		FILM NUMBER:		121051449

	BUSINESS ADDRESS:	
		STREET 1:		2929 SEVENTH STREET
		STREET 2:		SUITE 100
		CITY:			BERKELEY
		STATE:			CA
		ZIP:			94710
		BUSINESS PHONE:		5108485100

	MAIL ADDRESS:	
		STREET 1:		2929 SEVENTH STREET
		STREET 2:		SUITE 100
		CITY:			BERKELEY
		STATE:			CA
		ZIP:			94710
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>rrd354160.htm
<DESCRIPTION>MAA ACCEPTANCE
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			Prepared By R.R. Donnelley Financial -- Form 8-K
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				<b>UNITED STATES </b>
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				<b>SECURITIES AND EXCHANGE COMMISSION</b>
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				<b>Washington, D.C. 20549</b>
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				<b>Form 8-K </b>
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				<b>CURRENT REPORT</b>
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				<b>Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934</b>
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				<b>Date of Report (Date of earliest event reported):&nbsp;&nbsp;08/22/2012 </b>
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				<b>Dynavax Technologies Corporation</b>
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				<b>(Exact name of registrant as specified in its charter)</b>
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				<b>Commission File Number:&nbsp;&nbsp;001-34207</b>
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								<b>Delaware</b>
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								<b>33-0728374</b>
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								<b>(State or other jurisdiction of</b>
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								<b>(IRS Employer</b>
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								<b>incorporation)</b>
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								<b>Identification No.)</b>
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				<b>2929 Seventh Street, Suite 100</div><div Align="center">Berkeley, CA 94710-2753</b>
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				<b>(Address of principal executive offices, including zip code)</b>
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				<b>(510) 848-5100</b>
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				<b>(Registrant&#146;s telephone number, including area code)</b>
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				<b> </b>
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				<b>(Former name or former address, if changed since last report)</b>
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			<b>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:<BR><BR></b>
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			<b>[&nbsp;&nbsp;]&nbsp;&nbsp;
			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)<BR><BR>
			[&nbsp;&nbsp;]&nbsp;&nbsp;
			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)<BR><BR>
			[&nbsp;&nbsp;]&nbsp;&nbsp;
			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))<BR><BR>
			[&nbsp;&nbsp;]&nbsp;&nbsp;
			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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				<b>Item 8.01.&nbsp;&nbsp;&nbsp;&nbsp;Other Events</b>
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				On August 22, 2012, we issued a press release titled "Dynavax Marketing Authorization for HEPLISAV(TM) Accepted for Review by European Medicines Agency." A copy of the press release is attached as Exhibit 99.1 to this current report and is incorporated herein by reference.
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				<b>Item 9.01.&nbsp;&nbsp;&nbsp;&nbsp;Financial Statements and Exhibits</b>
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				(d) Exhibits.  The following exhibit is furnished herewith:<p>99.1&nbsp;&nbsp;&nbsp; Press Release, dated August 22, 2012, titled "Dynavax Marketing Authorization for HEPLISAV(TM) Accepted for Review by European Medicines Agency."<p>
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			<b>SIGNATURES</b>
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			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.
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							Dynavax Technologies Corporation
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							Date: August 23, 2012
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							By:
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						/s/&nbsp;&nbsp;&nbsp;&nbsp;Michael Ostrach</font>
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						Michael Ostrach</font>
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						Vice President and Chief Business Officer
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			<b>EXHIBIT INDEX</b>
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								<b>Exhibit&nbsp;No.</b>
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								<b>Description</b></font>
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								EX-99.1
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								Press release dated August 22, 2012, titled "Dynavax Marketing Authorization Application for HEPLISAV(TM) Accepted for Review by European Medicines Agency."</font>
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<DOCUMENT>
<TYPE>EX-99
<SEQUENCE>2
<FILENAME>rrd354160_38374.htm
<DESCRIPTION>PRESS RELEASE DATED AUGUST 22, 2012, TITLED "DYNAVAX MARKETING AUTHORIZATION APPLICATION FOR HEPLISAV(TM) ACCEPTED FOR REVIEW BY EUROPEAN MEDICINES AGENCY."
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<B><FONT FACE="Arial" SIZE=3><FONT FACE="Arial" SIZE=3><P>Contact:</B></FONT></FONT></TD>
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<FONT FACE="Arial" SIZE=3><FONT FACE="Arial" SIZE=3><P>Michael Ostrach</FONT></FONT></TD>
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<FONT FACE="Arial" SIZE=3><FONT FACE="Arial" SIZE=3><P>Vice President and Chief Business Officer </FONT></FONT></TD>
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<FONT FACE="Arial" SIZE=3><FONT FACE="Arial" SIZE=3><P>510-665-7257</FONT></FONT></TD>
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<FONT FACE="Arial" SIZE=3><FONT FACE="Arial" SIZE=3><P>mostrach@dynavax.com</FONT></FONT></TD>
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<P ALIGN="CENTER">&nbsp;</P>
<P ALIGN="CENTER"><A NAME="OLE_LINK9">DYNAVAX MARKETING AUTHORIZATION APPLICATION FOR HEPLISAV<SUP>TM</SUP> ACCEPTED FOR REVIEW BY EUROPEAN MEDICINES AGENCY  </P>
</B><P>BERKELEY, CA - August 22, 2012 - Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that the European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for HEPLISAV, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age and in patients with chronic kidney disease. Acceptance of the MAA confirms that the submission is sufficiently complete to permit a substantive review by the EMA.</P>
<P>&quot;This milestone marks the initiation of the regulatory review for HEPLISAV in Europe,&quot; said Dynavax President and Chief Medical Officer, Tyler Martin, M.D. &quot;We look forward to working through the review process with our designated rapporteur from Sweden and co-rapporteur from Belgium.&quot; </P>
<B><P>About HEPLISAV </P>
</B><P>HEPLISAV is an investigational adult hepatitis B vaccine for which a U.S. BLA has been accepted for review by the FDA and a MAA has been accepted for review by the EMA. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response. </P>
<B><P>About Dynavax </P>
</B><P>Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide higher and earlier protection with fewer doses than currently licensed vaccines. For more information visit www.dynavax.com. </P>
<B><P></A>Forward-Looking Statements </P>
</B><P>This press release may contain "forward-looking statements". Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and review and approval of HEPLISAV and our process for its manufacture can occur in a timely manner or without significant additional studies or difficulties or delays; whether our studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process, including whether the BLA and MAA will be approved; our ability to obtain additional financing to support the development and commercialization of HEPLISAV and our other operations; our ability to successfully transition to a commercial operation and execute on our commercial strategy; possible claims against us, including enjoining sales of HEPLISAV, based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC. </P>
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