Dynavax Technologies Corp.
Dynavax Technologies Corp. Sued by Investor
Robbins Arroyo LLP announces that a purchaser of Dynavax Technologies Corp. (NASDAQ: DVAX) securities has filed a complaint in the U.S. District Court for the Northern District of California. The complaint alleges that Dynavax and certain of its officers and directors violated the Securities Exchange Act of 1934 between April 26, 2012 and June 10, 2013 (the “Class Period”).
Dynavax Is Accused of Making False and Misleading Statements Regarding the Viability of HEPLISAV
The complaint alleges that during the Class Period, Dynavax issued a series of materially false and misleading statements concerning the viability of its lead product, HEPLISAV. According to the complaint, on April 26, 2012, the company announced that it had requested priority review of its U.S. Biologics License Application to the Food and Drug Administration for its HEPLISAV vaccine for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 to 70 years of age. In its announcement, the company cited its belief that the drug was a “significant improvement” over other marketed products. Then, on May 8, 2012, Dynavax reported its intent to develop its own commercial operation in order to launch HEPLISAV independently in the United States. According to the complaint, Dynavax lacked a reasonable basis for such positive statements as the company failed to disclose that the clinical trial for HEPLISAV was flawed because: (i) the trial demographics were not representative of the U.S. population; (ii) the trial lacked the typical one-year safety follow-up for vaccines; (iii) the trial lacked information concerning concomitant use with other vaccines; and (iv) the safety database size was inadequate. As a result of these false and misleading statements, Dynavax stock traded at artificially inflated prices during the Class Period, reaching a high of $5.26 per share on May 2, 2012.
Dynavax Stock Price Falls Dramatically on News Regarding Insufficient Data to Support the Safety of HEPLISAV
According to the complaint, On November 15, 2012, Dynavax announced that, among other things, an advisory committee of the FDA voted 8 to 5 that there was insufficient data to adequately support the safety of the HEPLISAV. On this news, the company’s stock price dropped approximately 47% to close at $2.44 per share on November 16, 2012. On February 25, 2013, the company announced that the FDA refused to approve HEPLISAV for use in adults 18 to 70 years of age without more safety data, resulting in the company’s stock price dropping an additional 32%, or $0.96 per share, to close at $2.01 per share on February 25, 2013. Finally, on June 10, 2013, Dynavax announced that the FDA would require the company to collect additional safety data prior to approval for use in the adults 18 to 70 years of age. On this news, Dynavax stock fell an additional 43%, to or $1.07 per share, to close at $1.40 per share on June 10, 2013.
If you invested in Dynavax and would like to discuss your shareholder rights, please contact attorney Darnell R. Donahue at (800) 350-6003 or you can complete the form below and we will contact you directly.