<SEC-DOCUMENT>0001181431-13-033812.txt : 20130610
<SEC-HEADER>0001181431-13-033812.hdr.sgml : 20130610
<ACCEPTANCE-DATETIME>20130610161410
ACCESSION NUMBER:		0001181431-13-033812
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20130610
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20130610
DATE AS OF CHANGE:		20130610

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:		13903589

	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
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<FILENAME>rrd382969.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;06/10/2013 </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 June 10, 2013, we issued a press release titled "Dynavax Reports Feedback from FDA Meeting Regarding HEPLISAV(TM)Biologic License Application." 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: </div><div align="left" style="text-indent:4%">99.1 Press Release, dated June 10, 2013, titled "Dynavax Reports Feedback from FDA Meeting Regarding HEPLISAV(TM)Biologic License Application."
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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: June 10, 2013
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							By:
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						/s/&nbsp;&nbsp;&nbsp;&nbsp;Jennifer Lew</font>
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						Jennifer Lew</font>
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						VP, Finance
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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 Feedback from FDA Meeting Regarding HEPLISAV(TM) Biologic License Application</font>
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<DOCUMENT>
<TYPE>EX-99
<SEQUENCE>2
<FILENAME>rrd382969_39658.htm
<DESCRIPTION>DYNAVAX REPORTS FEEDBACK FROM FDA MEETING REGARDING HEPLISAV(TM) BIOLOGIC LICENSE APPLICATION
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<B><FONT SIZE=2 COLOR="#008080"><FONT SIZE=2 COLOR="#008080"><P>Dynavax Technologies</P>
<P>2929 Seventh Street, Suite 100  </P>
<P>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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</FONT></FONT><FONT FACE="Arial" SIZE=3><FONT FACE="Arial" SIZE=3><P ALIGN="CENTER"><A NAME="OLE_LINK9">DYNAVAX REPORTS FEEDBACK FROM FDA MEETING REGARDING </P>
<P ALIGN="CENTER">HEPLISAV<SUP>TM</SUP> BIOLOGIC LICENSE APPLICATION</P>
<P ALIGN="CENTER"></P>
</B><P ALIGN="CENTER">- <B>Conference Call Scheduled for 9:00 a.m. ET Today</B> -</P>
<P>BERKELEY, CA - June 10, 2013 - Dynavax Technologies Corporation (NASDAQ: DVAX) today reported that it recently concluded a meeting with the U.S. Food and Drug Administration (FDA or Agency) regarding its Biologic License Application (BLA) for HEPLISAV, an investigational adult hepatitis B vaccine. The meeting followed recommendations expressed in November 2012 by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) regarding the size of Dynavax's safety database. The meeting with FDA resulted in the following messages:</P>
<UL>
<LI>The safety database does indeed need additional subjects;</LI>
<LI>VRBPAC's strong endorsement of HEPLISAV's demonstrated immunogenicity was acknowledged;</LI>
<LI>Analyzing the benefit/risk of HEPLISAV's use in discrete patient populations did not fundamentally address the shortfall in the safety database. It was concluded that to do so would unnecessarily restrict the patient population that could benefit from HEPLISAV's approval; </LI>
<LI>The additional safety data collected would facilitate review for an indication in adults 18-70 years of age.</LI></UL>
<P>&quot;We are encouraged by the supportive feedback received from the FDA and appreciate the informative interactions and clarity provided regarding HEPLISAV's path toward approval in the broader indication,&quot; commented Eddie Gray, Dynavax's Chief Executive Officer. &quot;We understand the rationale for the Agency's recommendations and will give full consideration to their feasibility and timing as we advance HEPLISAV's development.&quot; </P>
<P>Dynavax will meet with the FDA shortly to discuss the protocol for collecting the additional safety data, which is expected to be incorporated into the existing BLA. The Company also continues to work on the questions raised by the FDA in the Complete Response Letter (CRL) regarding the manufacturing and testing of HEPLISAV. Dynavax will provide updates as appropriate.</P>
<B><P>Conference Call Today</P>
</B><P>Dynavax management will host a conference call today at 9:00 a.m. Eastern Time (6:00 a.m. Pacific Time) and individuals may participate in the conference call by dialing (866) 428-9517 (domestic) or (224) 357-2389 (international).</P>
<P>To access a live audio webcast of the conference call, please visit the Company's website at http://investors.dynavax.com/newsevents.cfm&#9;</P>
<P>A replay of the webcast will be available on the Dynavax website approximately two hours after the conference call concludes through June 21, 2013.</FONT></FONT> </P>
<B><FONT FACE="Arial" SIZE=3><FONT FACE="Arial" SIZE=3><P>About HEPLISAV </P>
</B><P>HEPLISAV is an investigational adult hepatitis B vaccine for which US and European licensure applications have been accepted for review by the FDA and the EMA. 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 contains "forward-looking" statements, including expectations for HEPLISAV, our discussions with the FDA and the impact on our further plans to achieve approval, and expected timing of our responses with respect to the feedback from the regulatory agencies. 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 without significant delay or additional studies; whether our studies and manufacturing efforts can support registration for commercialization of HEPLISAV; the timing for achieving the size of the safety database that the FDA has provided guidance on; 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 a BLA or European licensure application will be approved; our ability to obtain additional financing to support the development and commercialization of HEPLISAV and our other operations; 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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