NEW YORK, Nov. 21, 2016 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a class action lawsuit has been filed against Dynavax Technologies Corporation (“Dynavax” or the “Company”) (Nasdaq:DVAX) in the United States District Court for the Northern District of California on behalf of purchasers of common stock of Dynavax between March 10, 2014 through November 11, 2016 (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the Securities Exchange Act of 1934.
Pursuant to the Complaint, Defendants made false and/or misleading statements and/or failed to disclose that: (1) there were significant adverse events associated with Dynavax’s HEPLISAV-B product, including an imbalance in the number of cardiac events during use; (2) consequently, a commercial product launch of HEPLISAV-B was less imminent than Dynavax had led investors to believe; and (3) as a result, Dynavax’s public statements were materially false and misleading at all relevant times.
On April 15, 2014, the Company announced the initiation of a new Phase 3 clinical trial of HEPLISAV-B (known as HBV-23). The Company further stated that this safety and immunogenicity study was designed to address the Complete Response Letter regarding the HEPLISAV-B Biologics License Application that was issued to the Company by the U.S. Food and Drug Administration (“FDA”) in February, 2013. This study is intended to significantly increase the number of vaccinated subjects and provide a sufficiently-sized safety database for the FDA to make a final determination regarding the safety and immunogenicity of the product.
On November 14, 2016, the Company announced it had received a complete response letter (“CRL”) from the FDA, requesting additional information on the Company’s HEPLISAV-B product in connection with its Biologics License Application. On this news, the Company’s share price fell $7.50, or 64.65%, to close at $4.10 on November 14, 2016.
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. If you wish to join the litigation, or to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at tjmckenna@gme-law.com or gegleston@gme-law.com.
Please visit our website at http://www.gme-law.com for more information about the firm.