San Diego, CA -- (SBWIRE) -- 11/30/2016 -- An investor, who purchased NASDAQ:DVAX shares, filed a lawsuit in California over alleged violations of Federal Securities Laws by Dynavax Technologies Corporation in connection with certain allegedly false and misleading statements.
Investors who purchased shares of Dynavax Technologies Corporation (NASDAQ:DVAX) have certain options and for certain investors are short and strict deadlines running. Deadline: January 17, 2017. NASDAQ:DVAX investors should contact the Shareholders Foundation at firstname.lastname@example.org or call 858-779-1554.
The plaintiff claims that the defendants made false and/or misleading statements and/or failed to disclose that there were significant adverse events associated with Dynavax Technologies' HEPLISAV-B product, including an imbalance in the number of cardiac events during use, that consequently, a commercial product launch of HEPLISAV-B was less imminent than Dynavax Technologies had led investors to believe, and that as a result, Dynavax Technologies' public statements were materially false and misleading at all relevant times.
On April 15, 2014, the Company announced, in its Securities and Exchange Commission 10-Q filing, the initiation of a new Phase 3 clinical trial of HEPLISAV-B (known as HBV-23). The Company further stated that this safety and immunogenicity study was designed to address the Complete Response Letter regarding the HEPLISAV-B Biologics License Application that was issued to Dynavax by the U.S. Food and Drug Administration in February, 2013. This study is intended to significantly increase the number of vaccinated subjects and provide a sufficiently-sized safety database for the FDA to make a final determination regarding the safety and immunogenicity of the product.
On September 2, 2016, the U.S. Food and Drug Administration ("FDA") announced that it had cancelled Dynavax Technologies Corporation's November 16, 2016 meeting with the Vaccines and Related Biological Products Advisory Committee "to allow time for the FDA to review and resolve several outstanding issues" with Dynavax's Biologics License Application for HEPLISAV-B™. The FDA further stated that it would schedule an Advisory Committee meeting in the future if necessary.
On November 14, 2016, Dynavax Technologies Corporation announced that it had received a Complete Response Letter from the U.S. Food and Drug Administration. According to Dynavax, the Complete Response Letter requests further information on several topics "including clarification regarding specific adverse events of special interest (AESIs), a numerical imbalance in a small number of cardiac events in a single study (HBV-23), new analyses of the integrated safety data base across different time periods, and post-marketing commitments." Shares of Dynavax Technologies Corporation (NASDAQ:DVAX) declined to as low as $3.20 per share on November 14, 2016.
On November 29, 2016, NASDAQ:DVAX closed at $4.75 per share.
Those who purchased shares of Dynavax Technologies Corporation have certain options and should contact the Shareholders Foundation.
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