A number of law firms have announced that they are investigating Dynavax Technologies Corporation (NASDAQ: DVAX) over potential breach of federal securities laws. Those investigations could result in class action lawsuits against the company.
Dynavax Technologies Corporation (NASDAQ: DVAX) is facing investigations by shareholder rights attorneys after cancellation of its previously scheduled meeting with a key FDA advisory committee. The meeting was intended to evaluate Dynavax’s hepatitis B vaccine called HEPLISAV-B. The cancellation of the advisory committee meeting is a setback for Dynavax and its shareholders as it will delay the approval of the candidate.
Shares of Dynavax fell more than 30% immediate the news about FDA’s cancellation of the advisory committee hearing reached the market.
Dynavax Technologies Corporation (NASDAQ: DVAX) had hoped that the FDA would approve HEPLISAV-B around mid-December, but those hopes have been thrown into doubt following the FDA’s latest move.
What the basis of the probe?
Basis of the Shareholder attorneys at Rosen Law Firm and Goldberg Law PC are probing Dynavax to see if the company made misleading statements regarding the prospects of HEPLISAV-B that may have contributed to losses to its shareholders. As such, the law firms are investigating the company on behalf of investors who acquired shares of the company before September 2 with the hope of helping them recover their losses.
The FDA said that the reason for cancelling the advisory committee hearing for Dynavax’s HEPLISAV-B is that it feels that it needs more time to review a number of outstanding issues relating to the application seeking approval of hepatitis B vaccine candidate.
However, the FDA would still schedule advisory committee hearing for Dynavax’s HEPLISAV-B in the future if it finds it necessary.
Regulatory setbacks – Dynavax Technologies Corporation (NASDAQ: DVAX)
Dynavax Technologies Corporation (NASDAQ: DVAX) is no stranger to regulatory controversies. Back in 2013 the FDA refused to approve HEPLISAV-B over worries that the vaccine could cause autoimmune problems.
However, the latest setback doesn’t appear to be linked to any worries regarding adverse events of using HEPLISAV-B. If cleared for marketing, Dynavax’s HEPLISAV-B is expected to have an edge against GlaxoSmithKline plc (ADR) (NYSE: GSK)’s Engerix-B because it has a better dosing schedule.