Lawsuit Overview
June 4, 2018 - The court granted defendants' motion to dismiss without leave to amend.
November 3, 2017 - A motion to dismiss the second amended consolidated complaint was filed.
October 3, 2017 - A second amended consolidated complaint was filed.
September 12, 2017 - The court granted the defendants' motion to dismiss. The plaintiffs were given leave to amend the complaint.
May 2, 2017 - A motion to dismiss the amended consolidated complaint was filed.
March 17, 2017 - An amended consolidated complaint was filed.
November 18, 2016 - An investor in shares of Dynavax Technologies Corporation (NASDAQ: DVAX) filed a lawsuit in the U.S. District Court for the Northern District of California over alleged violations of Federal Securities Laws by Dynavax Technologies Corporation in connection with certain allegedly false and misleading statements made between March 10, 2014 and November 11, 2016.
According to the complaint the plaintiff alleges on behalf of purchasers of Dynavax Technologies Corporation (NASDAQ: DVAX) common shares between March 10, 2014 and November 11, 2016, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between March 10, 2014 and November 11, 2016 the defendants made false and/or misleading statements and/or failed to disclose that there were significant adverse events associated with Dynavax Technologies Corporation’s 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 Corporation had led investors to believe, and that as a result, Dynavax Technologies Corporation’s 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 Technologies Corporation’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 Technologies Corporation, 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 18, 2016, NASDAQ: DVAX closed at $4.70 per share.