SAN DIEGO--(BUSINESS WIRE)--
Robbins Geller Rudman & Dowd LLP (“Robbins Geller”) (http://www.rgrdlaw.com/cases/dynavax/) today announced that 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 Corporation (“Dynavax”) (DVAX) common stock during the period between April 26, 2012 and June 10, 2013 (the “Class Period”).
If you wish to serve as lead plaintiff, you must move the Court no later than 60 days from today. If you wish to discuss this action or have any questions concerning this notice or your rights or interests, please contact plaintiff’s counsel, Darren Robbins of Robbins Geller at 800/449-4900 or 619/231-1058, or via e-mail at email@example.com. If you are a member of this class, you can view a copy of the complaint as filed or join this class action online at http://www.rgrdlaw.com/cases/dynavax/. 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.
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.
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.
Plaintiff seeks to recover damages on behalf of all purchasers of Dynavax common stock during the Class Period (the “Class”). The plaintiff is represented by Robbins Geller, which has expertise in prosecuting investor class actions and extensive experience in actions involving financial fraud.
Robbins Geller represents U.S. and international institutional investors in contingency-based securities and corporate litigation. With nearly 200 lawyers in nine offices, the firm represents hundreds of public and multi-employer pension funds with combined assets under management in excess of $2 trillion. The firm has obtained many of the largest recoveries in history and has been ranked number one in the number of shareholder class action recoveries in MSCI’s Top SCAS 50 every year since 2003. Please visit http://www.rgrdlaw.com for more information.
- Company Legal & Law Matters
- Pharmaceuticals & Drug Trials
- Robbins Geller