Dynavax investors may receive additional information about the case by clicking the link "Join this Class Action" above.
According to the complaint, Dynavax is a clinical-stage biopharmaceutical company that 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 Class Period commences March 10, 2014, when Dynavax filed an Annual Report for the quarter and year ended December 31, 2013 on Form 10-K with the SEC.
According to the complaint, 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, 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.” (Emphasis added)
Following this news, Dynavax’s share price fell $7.50, or 64.65%, to close at $4.10 on November 14, 2016.
The complaint alleges throughout the Class Period, the 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.
If you are a member of the class described above, you may no later than January 17, 2017 move the Court to serve as lead plaintiff of the class, if you so choose.
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. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of their choice, or may choose to do nothing and remain an inactive class member.
Kessler Topaz Meltzer & Check, LLP has not filed a complaint in this matter. If you wish to discuss this action or have any questions concerning this notice or your rights or interests with respect to these matters, please contact Kessler Topaz Meltzer & Check, LLP toll free at 1-888-299-7706 or 1-610-667-7706, or via e-mail at info@ktmc.com.
CONTACT:
Kessler Topaz Meltzer & Check, LLP
James Maro, Esq. or Adrienne Bell, Esq.
280 King of Prussia Road
Radnor, PA 19087 1-888-299-7706 (toll free) or 1-610-667-7706
Or by e-mail at info@ktmc.com