<SEC-DOCUMENT>0001181431-12-025803.txt : 20120426
<SEC-HEADER>0001181431-12-025803.hdr.sgml : 20120426
<ACCEPTANCE-DATETIME>20120426163702
ACCESSION NUMBER:		0001181431-12-025803
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20120426
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20120426
DATE AS OF CHANGE:		20120426

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:		12784109

	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>rrd343143.htm
<DESCRIPTION>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;04/26/2012 </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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								<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 April 26, 2012, we issued a press release titled "Dynavax Reports HEPLISAV BLA Submission." 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</div><div align="left" style="text-indent:4%">Exhibit No.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Description</div><div align="left" style="text-indent:4%">99.1&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Press Release, dated April 26,2012, titled "Dynavax Reports HEPLISAV BLA Submission."
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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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					&nbsp;
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							Date: April 26, 2012
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							By:
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					&nbsp;
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						/s/&nbsp;&nbsp;&nbsp;&nbsp;Michael S. Ostrach </font>
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						Michael S. Ostrach </font>
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						Vice President
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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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								Dynavax Reports HEPLISAV BLA Submission</font>
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<DOCUMENT>
<TYPE>EX-99
<SEQUENCE>2
<FILENAME>rrd343143_37630.htm
<DESCRIPTION>DYNAVAX REPORTS HEPLISAV BLA SUBMISSION
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<B><P ALIGN="RIGHT">Exhibit 99.1</P>
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</FONT></FONT></FONT><B><FONT SIZE=2 COLOR="#008080"><FONT SIZE=2 COLOR="#008080"><P ALIGN="RIGHT">    2929 Seventh Street, Suite 100   </P>
<P ALIGN="RIGHT">             Berkeley, CA 94710</P>
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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"><A NAME="OLE_LINK9">DYNAVAX REPORTS HEPLISAV<SUP>TM</SUP> BLA SUBMISSION  </P>
</B><P>BERKELEY, CA -April 26, 2012 - Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that it has submitted a U.S. Biologics License Application (BLA) to the Food and Drug Administration (FDA) 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.</P>
<P>Dynavax President and Chief Medical Officer, Tyler Martin, M.D., said:</P><DIR>
<DIR>
<P>This submission is a very important milestone for Dynavax. The final document consists of 305 volumes, and the expansion of the indicated age group following the pre-BLA meeting required complete rewrites of the clinical summaries. The entire HEPLISAV team did outstanding work to complete the revisions and submit the BLA ahead of schedule. </P>
<P>We have requested priority review for HEPLISAV, as we believe it is a significant improvement compared to marketed products. We look forward to working with the FDA on the BLA and to ultimately bringing the benefits of HEPLISAV to the public.</P></DIR>
</DIR>
<P>The Company anticipates submitting a European Marketing Authorization Application (MAA) for HEPLISAV in the third quarter of 2012. Upon approval of the initial HEPLISAV BLA, Dynavax plans to submit a supplemental BLA with an indication and 3-dose primary vaccination regimen for patients with chronic kidney disease. </P>
<B><P>About HEPLISAV </P>
</B><P>HEPLISAV is an investigational adult hepatitis B vaccine. 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 contains "forward-looking statements," including those relating to the HEPLISAV planned indications and regimens and timing of BLA and MAA submissions, that are subject to a number of risks and uncertainties. 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 approval of HEPLISAV and our process for its manufacture can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, 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 will be accepted for filing; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company 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 the Company's current periodic reports with the SEC. </P>
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