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Dynavax Technologies Corp (DVAX.OQ)

DVAX.OQ on NASDAQ Stock Exchange Capital Market

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Latest Key Developments (Source: Significant Developments)

Dynavax technologies Q4 loss per share $0.56
Monday, 13 Mar 2017 06:00am EDT 

Dynavax Technologies Corp : Q4 revenue $7.3 million versus $0.7 million . Dynavax technologies says had cut workforce by about 40 percent as part of jan. restructuring . Dynavax reports fourth quarter and year end 2016 financial results and company update . Q4 revenue view $1.5 million -- Thomson Reuters I/B/E/S . Dynavax technologies corp qtrly loss per share $0.56 . Q4 earnings per share view $-0.85, revenue view $1.5 million -- Thomson Reuters I/B/E/S .Dynavax technologies as part of jan. Restructuring, suspended manufacturing activities, commercial preparations,other longer term investment related to Heplisav-B.  Full Article

Dynavax announces FDA acceptance
Tuesday, 28 Feb 2017 04:01pm EST 

Dynavax Technologies Corp : Dynavax announces FDA acceptance for review of its complete response to November 2016 CRL and PDUFA action date for heplisav-b(tm) .Dynavax Technologies Corp- FDA has established August 10, 2017 as prescription drug user fee act (PDUFA) action date for heplisav-b(tm).  Full Article

Dynavax restructures and emphasizes immuno-oncology program
Thursday, 5 Jan 2017 12:55pm EST 

Dynavax Technologies Corp : Dynavax restructures and emphasizes immuno-oncology program . Suspended manufacturing for HEPLISAV-B and reduced its global workforce by 38 percent . Dynavax Technologies Corp says company will incur restructuring costs, currently estimated to be $3.0 million, primarily in Q1 of 2017 . Estimates that its cash, cash equivalents and marketable securities were approximately $81.4 million as of December 31, 2016 . Has implemented significant organizational restructuring and cost reductions to align around its immuno-oncology business . Restructuring is currently estimated to result in approximately a 40 percent reduction in cash burn . Dynavax Technologies Corp says will continue to evaluate possibility of partnership to support HEPLISAV-B . Developing a second TLR9 agonist, DV281, which has completed preclinical testing in models for lung cancer . Continues to believe that HEPLISAV-B is an approvable product . Dynavax intends to begin phase 1 studies of DV281 in Q2 of 2017 . Plans to respond this month to November 2016 CRL from FDA regarding its biologics license application (BLA) for HEPLISAV-B . Expects to present additional data from its immuno-oncology portfolio at medical conferences throughout 2017 . Plans to submit its response to FDA's outstanding questions shortly relating to HEPLISAV-B . Dynavax will retain, but furlough, majority of workforce supporting its manufacturing facility in Germany.  Full Article

Dynavax reports Q3 2016 financial results and company update
Monday, 7 Nov 2016 06:00am EST 

Dynavax Technologies Corp : Dynavax Technologies Corp says preparations for launch of HEPLISAV-B are continuing, including pre-commercial activities . Dynavax reports third quarter 2016 financial results and company update . Q3 loss per share $0.90 . Q3 revenue $200,000 versus $1.2 million . Q3 revenue view $2.4 million -- Thomson Reuters I/B/E/S .Q3 earnings per share view $-0.75 -- Thomson Reuters I/B/E/S.  Full Article

Dynavax secures committed financing for $100 mln of senior secured notes
Thursday, 27 Oct 2016 07:00am EDT 

Dynavax Technologies Corp : Secures committed financing from Deerfield for $100 million of senior secured notes .Says one or more funds of Deerfield management agreed to purchase $100 million principal amount of Dynavax's notes.  Full Article

Dynavax Technologies received anticipated requests for information from FDA review team in connection with pending BLA for HEPLISAV-B
Monday, 3 Oct 2016 06:52am EDT 

Dynavax Technologies Corp : Review team's questions are in line with company's expectations . Working with FDA to resolve remaining questions in order to enable FDA to complete review by scheduled PDUFA action date of Dec 15 . Received anticipated requests for information from FDA review team in connection with pending BLA for HEPLISAV-B .PDUFA action date of December 15, 2016 remains unchanged.  Full Article

U.S. FDA cancels Dynavax's Nov advisory committee meeting
Friday, 2 Sep 2016 01:02pm EDT 

: U.S. FDA says November advisory committee meeting to discuss hepatitis B vaccine from Dynavax Technologies Corp has been canceled .U.S. FDA says Dynavax advisory committee meeting canceled to allow time for the FDA to review and resolve several outstanding issues.  Full Article

Dynavax announces FDA advisory committee meeting to review HEPLISAV-B
Friday, 5 Aug 2016 05:31pm EDT 

Dynavax Technologies Corp : Announces FDA advisory committee meeting to review HEPLISAV-B . FDA has indicated it will communicate questions for VRBPAC to address closer in time to meeting date. .Vaccines and related biological products advisory committee will review biologics license application for HEPLISAV-BÂ on Nov 16.  Full Article

Dynavax Q1 loss per share $0.70
Monday, 9 May 2016 09:00am EDT 

Dynavax Technologies Corp : Qtrly total revenues $942,000 versus $627,000 . Q1 earnings per share view $-0.63, revenue view $1.1 million -- Thomson Reuters I/B/E/S . Dynavax reports first quarter 2016 financial results . Q1 loss per share $0.70 . Q1 revenue rose 50 percent .Q1 earnings per share view $-0.63 -- Thomson Reuters I/B/E/S.  Full Article

Dynavax Technologies Corp and AstraZeneca amend their agreement for asthma drug candidate
Tuesday, 19 Jan 2016 04:00pm EST 

Dynavax Technologies Corp:Says Dynavax and Astrazeneca amend their agreement for asthma drug candidate.Astrazeneca to now conduct phase 2a safety,efficacy trial of azd1419 in asthma patients.Companies decided to bypass a planned phase 1b trial and proceed to phase 2a, a study that was to be conducted by Dynavax.  Full Article

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BRIEF-Dynavax announces FDA acceptance

* Dynavax announces FDA acceptance for review of its complete response to November 2016 CRL and PDUFA action date for heplisav-b(tm)