<SEC-DOCUMENT>0001181431-12-058861.txt : 20121115
<SEC-HEADER>0001181431-12-058861.hdr.sgml : 20121115
<ACCEPTANCE-DATETIME>20121115171308
ACCESSION NUMBER:		0001181431-12-058861
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20121115
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20121115
DATE AS OF CHANGE:		20121115

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:		121209509

	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
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<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>rrd360599.htm
<DESCRIPTION>FORM 8-K
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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;11/15/2012 </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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							&nbsp;&nbsp;
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								<b>33-0728374</b>
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								<b>(State or other jurisdiction of</b>
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							&nbsp;&nbsp;
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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 November 15, 2012, we issued a press release titled "Dynavax Announces FDA Advisory Committee Meeting Outcome for HEPLISAV(TM)." 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.<p>The following exhibit is furnished herewith:<p>EX-99.1&nbsp;&nbsp;&nbsp;  Press Release, dated November 15, 2012, titled "Dynavax Announces FDA Advisory Committee Meeting Outcome for HEPLISAV(TM)".
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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: November 15, 2012
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							By:
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						/s/&nbsp;&nbsp;&nbsp;&nbsp;Christine R. Larson</font>
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						Christine R. Larson</font>
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						Vice President and Chief Financial 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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						<font Face="times New Roman" Size="2">&nbsp;&nbsp;</font>
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								Press Release, dated November 15, 2012, titled "Dynavax Announces FDA Advisory Committee Meeting Outcome for HEPLISAV(TM)." </font>
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<DOCUMENT>
<TYPE>EX-99
<SEQUENCE>2
<FILENAME>rrd360599_38797.htm
<DESCRIPTION>PRESS RELEASE, DATED NOVEMBER 15, 2012, TITLED "DYNAVAX ANNOUNCES FDA ADVISORY COMMITTEE MEETING OUTCOME FOR HEPLISAV(TM)."
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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>
</FONT></FONT><FONT FACE="Arial" SIZE=3><FONT FACE="Arial" SIZE=3><P ALIGN="CENTER"><A NAME="OLE_LINK9">DYNAVAX ANNOUNCES FDA ADVISORY COMMITTEE MEETING OUTCOME </P>
<P ALIGN="CENTER">FOR HEPLISAV<SUP>TM</SUP> </P>
</B><P>BERKELEY, CA - November 15, 2012 - Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (Committee) voted 13 to one that HEPLISAV data adequately demonstrated immunogenicity. Additionally, the Committee voted eight to five with one abstention that there was insufficient data to adequately support the safety of HEPLISAV.</P>
<P>Now that Dynavax has received the Committee's input and vote, the Company will continue working with the FDA as it completes its review of the HEPLISAV application. The scheduled Prescription Drug User Fee Act (PDUFA) date for HEPLISAV is February 24, 2013.</P>
<B><P>About HEPLISAV </P>
</B><P>HEPLISAV is an investigational adult hepatitis B vaccine for which U.S. and European licensure applications have been accepted for review by the FDA and the EMA. The PDUFA date for completion of the FDA review of the HEPLISAV Biologic License Application (BLA) is February 24, 2013. 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, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. Dynavax's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine. For more information visit www.dynavax.com. </P>
<B><P>Forward-Looking Statements </P>
</B><P>This press release may contain "forward-looking&quot; 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 the European licensure application 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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