Investor sues Dynavax
The lawsuit alleges that between April 26, 2012 and June 10, Dynavax issued multiple materially misleading and false statements related to the viability of HEPLISAV, the company's hepatitis B vaccine and lead product. Dynavax allegedly made positive statements without a reasonable basis, such as its belief the drug was a significant improvement over other marketed products for all known subtypes of hepatitis B virus in adults 18 to 70 years of age.
The lawsuit alleges Dynavax failed to disclose that its HEPLISAV clinical trial was flawed in four key ways. The company allegedly failed to disclose that the trial demographics were not representative of the U.S. population, the trial lacked a standard one-year safety follow-up for vaccines, the trial lacked information related to concomitant use with other vaccines and the safety database size was inadequate. The statements allegedly caused Dynavax stock to trade at artificially inflated prices during the class period, reaching its height at $5.26 per share on May 2, 2012.
After requesting priority review for its U.S. biologics license application to the U.S. Food and Drug Administration for HEPLISAV on April 26, 2012, an advisory committee of the FDA voted eight to five that there was insufficient data to adequately support the safety of HEPLISAV. The stock price dropped 47 percent on that news and dropped an additional 32 percent on February 25 when the FDA refused to approve HEPLISAV in adults 18 to 70 years of age without additional safety data. Dynavax announced the FDA would require the company to collect additional safety data prior to HEPLISAV's approval on June 10, causing another stock drop of 43 percent.
The company's stock was $5.26 per share on May 2, $2.44 per share on November 16, $2.01 per share on February 25 and $1.40 per share on June 10.
The lawsuit alleges Dynavax and certain of its directors and officers violated the Securities Exchange Act of 1934 between April 26, 2012 and June 10.