FDA again reviewing Dynavax's Heplisav-B

Dynavax Technologies Corp. (NASDAQ:DVAX) said FDA accepted for filing a BLA for Heplisav-B to prevent HBV in adults. Its PDUFA date is Sept. 15.

In January, Dynavax said Heplisav-B met the co-primary endpoints of safety and non-inferiority to Engerix-B from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) in a Phase III trial (see BioCentury Extra, Jan. 7). ...