FDA needs more time to review Dynavax's HEPLISAV-B BLA, action date pushed out to December 15; shares down 17% premarket

• Dynavax Technologies (NASDAQ:DVAX) is off 17% premarket on the news that the FDA requires more time to review the company's Biologics License Application (BLA) seeking approval of hepatitis B vaccine candidate HEPLISAV-B. The agency's action date (PDUFA) has been extended three months to December 15. The delay is due to the submission of individual trial data sets that were requested by the FDA. The data were integrated in the initial filing.