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For more information regarding this class action suit, please contact Ryan & Maniskas, LLP (
Richard A. Maniskas, Esquire) toll-free at (877) 316-3218 or by email at
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The complaint charges Dynavax and certain of its officers and directors with violations of the Securities Exchange Act of 1934. Dynavax, a clinical-stage biopharmaceutical company, discovers and develops products to prevent and treat infectious and inflammatory diseases. Dynavax's lead product candidate is HEPLISAV™, a Phase 3 investigational adult hepatitis B vaccine designed to provide higher and earlier protection with fewer doses than licensed vaccines.
The complaint alleges that throughout the Class Period, defendants violated the federal securities laws by disseminating false and misleading statements to the investing public about the viability of HEPLISAV. As a result of defendants' false statements, Dynavax stock traded at artificially inflated prices during the Class Period, reaching a high of
$5.26 per share on
May 2, 2012.
April 26, 2012, Dynavax announced it had submitted a Biologics License Application ("BLA") to the Food and Drug Administration ("FDA") for HEPLISAV, seeking approval for the vaccine against all known subtypes of the hepatitis B virus in adults ages 18 to 70. On
November 15, 2012, Dynavax announced that while the FDA's Vaccines and Related Biological Products Advisory Committee had voted 13 to 1 that the data supported the efficacy of HEPLISAV, the committee voted 8 to 5 that there was not sufficient data to adequately support the safety of HEPLISAV. On this news, Dynavax stock fell
$2.19 per share to close at
$2.44 per share on
November 16, 2012. On
February 25, 2013, Dynavax announced that it received a Complete Response Letter ("CRL") from the FDA regarding its BLA for HEPLISAV, which stated that, among other things, HEPLISAV could not be approved for the full adult label of 18-70 years old without additional safety data, though the FDA indicated a willingness to consider approving the drug under a restricted-use label. Then, on
June 10, 2013, Dynavax announced that it had recently conducted a follow-up meeting with the FDA regarding its BLA license for HEPLISAV. According to the Company, the FDA would require Dynavax to conduct additional safety trials before the FDA would even consider approving HEPLISAV. On this news, Dynavax stock fell another
$1.07 per share to close at
$1.40 per share on
June 10, 2013, a one-day decline of 43%.
If you are a member of the class, you may, no later than
August 19, 2013, request that the Court appoint you as lead plaintiff of the class. A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member's claim is typical of the claims of other class members, and that the class member will adequately represent the class. Under certain circumstances, one or more class members may together serve as "lead plaintiff." Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. You may retain Ryan & Maniskas, LLP or other counsel of your choice, to serve as your counsel in this action.
For more information about the case or to participate online, please visit:
www.rmclasslaw.com/cases/dvax or contact
Richard A. Maniskas, Esquire toll-free at (877) 316-3218, or by e-mail at
firstname.lastname@example.org. For more information about class action cases in general or to learn more about Ryan & Maniskas, LLP, please visit our website:
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