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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 says FDA approves Heplisav-B for Hepatitis B prevention in adults
Friday, 10 Nov 2017 

Nov 9 (Reuters) - Dynavax Technologies Corp :Dynavax announces FDA approval of Heplisav-B for prevention of Hepatitis B in adults.Dynavax Technologies Corp - ‍expects to commercially launch Heplisav-B in United States in Q1 of 2018​.  Full Article

Dynavax reports Q3 loss per share $0.38
Friday, 3 Nov 2017 

Nov 3 (Reuters) - Dynavax Technologies Corp :Dynavax reports third quarter 2017 financial results.Q3 loss per share $0.38.Q3 earnings per share view $-0.47 -- Thomson Reuters I/B/E/S.Dynavax Technologies Corp - Qtrly total revenue $53,000 versus $162,000‍​.Dynavax Technologies - ‍Cash, cash equivalents & marketable securities were $191.7 million at Sept 30, 2017 compared to $81.4 million at Dec 31, 2016​.  Full Article

Dynavax initiates clinical trial in non-small cell lung cancer with a novel inhaled TLR9 Agonist
Thursday, 19 Oct 2017 

Oct 19 (Reuters) - Dynavax Technologies Corp :Dynavax initiates clinical trial in non-small cell lung cancer with a novel inhaled TLR9 Agonist in combination with Anti-PD-1 therapy.Dynavax Technologies - ‍dose escalation study is expected to enroll about 24 patients in 5 cohorts with advanced NSCLC.  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 

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 

: 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
Saturday, 6 Aug 2016 

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 

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
Wednesday, 20 Jan 2016 

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

Dynavax's hepatitis B vaccine gets FDA nod on third try, shares up

Dynavax Technologies Corp's hepatitis B vaccine won the U.S. Food and Drug Administration's approval on the third attempt and Chief Executive Eddie Gray told Reuters the company was open to, but not waiting for, a partner to market the drug.