ARTICLE | Company News
Dynavax still expecting timely Heplisav-B decision
September 6, 2016 7:00 AM UTC
Dynavax Technologies Corp. (NASDAQ:DVAX) gained $3.09 (28%) to $14 on Tuesday after it said FDA expects to reach a decision on the company's BLA for HBV vaccine Heplisav-B by its Dec. 15 PDUFA date.
On Friday, FDA canceled a planned Nov. 16 advisory meeting to discuss the BLA, saying it needed additional time "to review and resolve several outstanding issues" (see BioCentury Extra, Sept. 2). ...