Dynavax slides after FDA extends review of Heplisav-B

Dynavax Technologies Corp. (NASDAQ:DVAX) fell $2.45 (12%) to $18.53 on Wednesday after it said FDA extended by three months its review of a BLA for Heplisav-B to prevent HBV in adults. The new PDUFA date is Dec. 15; it was Sept. 15.

Dynavax said it submitted individual trial data sets this month at FDA's request, which the agency considered a major amendment to the BLA. The company had submitted integrated data in its BLA, which FDA accepted last month. ...