​Securities Class Action

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​​The FDA seeks more information regarding
​Dynavax’s HEPLISAV-B Biologics License Application and  Dynavax is forced to recruit a pharmaceutical or financial partner to gain approval.  Dynavax’s share price falls $7.50 or 64.65% on this news and closes at $4.10 on November 14, 2016
Class Period
March 10, 2014 to November 11, 2016
Lead Plaintiff Motion Deadline
January 17, 2017
Stock Symbol
Northern District of California


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    About this action:​A class action has been commenced in the United States District Court for the Northern District of California on behalf of purchasers of Dynavax Technologies Corp. (“Dynavax”) (NASDAQ: DVAX) common stock between March 10, 2014 and November 11, 2016  (the “Class Period”).

    ​If you wish to serve as lead plaintiff, you must move the Court no later than January 17, 2017.  A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member.

    ​If you would like more information about getting involved in the Dynavax Class Action, please fill out the form to the left, or contact Sheila Feerick at 1-800-221-0015, or email

    info@SafirsteinMetcalf.com.  Safirstein Metcalf LLP represents individual and institutional clients in a wide variety of litigation, with an emphasis on class, derivative, and other complex actions on behalf of investors and consumers. The firm handles matters on a contingency fee basis.

    ​Dynavax is a clinical-stage biopharmaceutical company, discovers and develops novel vaccines and therapeutics in the United States. The Company’s development programs focus on vaccine adjuvants, cancer immunotherapy, and autoimmune and inflammatory diseases. The Company’s lead products include HEPLISAV-B, an investigational adult hepatitis B vaccine, which is in Phase III clinical trials

    The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) there were significant adverse events associated with Dynavax’s HEPLISAV-B product, including an imbalance in the number of cardiac events during use; (ii) consequently, a commercial product launch of HEPLISAV-B was less imminent than Dynavax had led investors to believe; and (iii) as a result, Dynavax’s public statements were materially false and misleading at all relevant times.On November 14, 2016, pre-market, the Company announced it had received a complete response letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”), requesting additional information on the Company’s HEPLISAV-B product in connection with its Biologics License Application. The Company stated, in part:
    The CRL seeks information regarding several topics, including clarification regarding specific adverse events of special interest (AESIs), a numerical imbalance in a small number of cardiac events in a single study (HBV-23), new analyses of the integrated safety data base across different time periods, and post-marketing commitments. In the CRL, the FDA acknowledged that it has not yet completed its review of responses received from Dynavax in early October, including those pertaining to AESIs and the numerical imbalance in cardiac events. The responses included an extensive analysis that included independent expert consultation supporting our view that the imbalance was driven by an unexpectedly low number of events in the comparator arm. It would appear the Agency could not fully assess the responses in the current review period. In the CRL, there is no request for additional clinical trials and there are no apparent concerns with rare serious autoimmune events.
    “The CRL is consistent with our opinion that HEPLISAV-B is approvable and we are seeking to meet with the FDA as soon as possible,” said Eddie Gray, chief executive officer of Dynavax. “However, the time and resources that will be required to gain approval leads us to consider that we may not be able to advance this program on our own and we are moving swiftly to identify a potential pharmaceutical or financial partner.”
    (Emphasis added.)On this news, Dynavax’s share price fell $7.50, or 64.65%, to close at $4.10 on November 14, 2016.