Zeldes Haeggquist & Eck, LLP has commenced an investigation into Dynavax Technologies Corporation (“Dynavax” or the “Company”) (NASDAQ: DVAX) to determine whether certain officers and directors of the Company breached their fiduciary duties to shareholders. Dynavax is a clinical-stage biopharmaceutical company focused on the discovery and development of products for the prevention and treatment infectious and inflammatory diseases. The investigation concerns the clinical trial of Dynavax’s lead product candidate, HEPLISAV™ (“HEPLISAV”), a Phase III investigational hepatitis B vaccine.
On April 26, 2012, Dynavax announced it had submitted a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for HEPLISAV, seeking approval for the vaccine against all known subtypes of the hepatitis B virus in adults aged 18 to 70. On November 15, 2012, Dynavax announced that the FDA’s Vaccines and Related Biological Products Advisory Committee had voted 13 to 1 that the data supported the efficacy of HEPLISAV, however, the committee voted 8 to 5 that Dynavax had not collected data sufficient to support the safety of HEPLISAV.
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 HEPLISAV could not be approved for the full adult label of 18-70 years old without additional safety data, though approval of a restricted use might be considered. 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 studies before the FDA would further consider the approval of HEPLISAV.
The necessity to conduct an additional safety trial is a major setback for Dynavax and its shareholders.
If you are an investor in Dynavax, you may have legal claims against Dynavax and/or its Officers and Directors. If you wish to discuss this investigation, or have questions about this notice or your legal rights, please contact attorney Amber L. Eck at 619-342-8000, or by email at firstname.lastname@example.org. There is no cost to you.