Investigation Overview
June 17, 2013 (Update) - On June 10, 2013 - Dynavax Technologies Corporation reported that it recently concluded a meeting with the U.S. Food and Drug Administration (FDA) regarding its Biologic License Application for HEPLISAV, an investigational adult hepatitis B vaccine.
Shares of Dynavax Technologies Corporation (NASDAQ:DVAX) fell from $2.55 per share on June 6, 2013 to $1.22 per share on June 13, 2013.
Mar. 5, 2013 (Update) -- On Feb. 25, 2013, Dynavax Technologies Corporation announced that it received a Complete Response Letter from the U.S. Food and Drug Administration (FDA or Agency) regarding its Biologic License Application for HEPLISAV, an investigational adult hepatitis B vaccine.
Among other things, the FDA specified in the complete response letter, that the indication in adults 18-70 years of age cannot be approved without further evaluation of safety in this broad age group.
Shares of Dynavax Technologies Corporation (NASDAQ:DVAX) declined from $3.118 per share on Feb. 22, 2013 to $1.87 per share on Feb. 25, 2013.
On March 5, 2013, NASDAQ:DVAX shares closed at $1.84 per share, which is substantially below its current 52 week high of $5.34 per share.
Nov. 23, 2012 (Shareholders Foundation) -- An investigation on behalf of investors of Dynavax Technologies Corporation (NASDAQ:DVAX) shares over potential securities laws violations by Dynavax Technologies Corporation and certain of its directors and officers in connection certain financial statements was announced .
The investigation by a law firm focuses on possible claims on behalf of purchasers of the securities of Dynavax Technologies Corporation (NASDAQ:DVAX) concerning whether a series of statements by Dynavax Technologies Corporation regarding its business, its prospects and its operations were materially false and misleading at the time they were made.
Dynavax Technologies Corporation (NASDAQ:DVAX) reported that its annual Revenue fell from $23.95 million in 2010 to $21.61 million in 2011. However, Dynavax Technologies Corporation reported that its Net Loss decreased from $57.31 million in 2010 to $48.60 million in 2011.
Shares of Dynavax Technologies Corporation (NASDAQ:DVAX) grew from as low as $0.24 per share in November 2008 to as high as $5.15 per share in April, respectively $4.91 per share in October 2012.
Then on November 15, 2012, Dynavax Technologies Corporation 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. However, Dynavax Technologies Corporation also said that the Committee voted eight to five with one abstention that there was insufficient data to adequately support the safety of HEPLISAV.
Shares of Dynavax Technologies Corporation (NASDAQ:DVAX) fell from $4.83 per share on Nov. 14, 2012 to $2.30 per share on Nov. 16, 2012.