According to the law firm press release, 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.
On 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%.
According to the complaint, the true facts, which were known by defendants but concealed from the investing public during the Class Period, included that the clinical trial for HEPLISAV was flawed as it was not representative of the population in the United States and lacked information concerning concomitant use of HEPLISAV with other vaccines, and Dynavax failed to provide the FDA with sufficient data concerning its manufacturing processes and controls for HEPLISAV on its BLA.
On September 27, 2013, the Court granted the motion appointing Lead Plaintiff and their selection of Faruqi & Faruqi, LLP was appointed lead plaintiff in this action.
On November 12, 2013, a Consolidated Class Action Complaint was filed by the lead plaintiff against the defendants.
On April 7, 2014 an Amended Consolidated Class Action Complaint was filed on behalf of investors who purchased or otherwise acquired Dynavax securities between April 26, 2012 and June 10, 2013, inclusive (the “Class 23 Period”), seeking to pursue remedies under Section 10(b), 20A and 20(a) of the Securities 24 Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder.
The parties filed a Stipulation of Settlement on September 8, 2016. The Court preliminarily approved the Settlement on October 17.