Dynavax jumps on HEPLISAV-B HBV data

Dynavax Technologies Corp. (NASDAQ:DVAX) jumped $8.52 (40%) to $29.70 on Thursday after its HEPLISAV-B met the co-primary endpoints of overall safety and non-inferiority of seroprotection in diabetic participants compared with marketed HBV vaccine Engerix-B from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) in the Phase III HBV-23 trial. HEPLISAV-B also showed non-inferiority of seroprotection to Engerix-B among all the study's participants.

Dynavax conducted HBV-23 to create a sufficiently sized safety database for FDA, which issued a complete response letter for HEPLISAV-B in 2013. According to the company, the agency issued the CRL because "hypothetical risks of the novel adjuvant warranted a larger safety database to assess the possibility of rare autoimmune side effects." In 2012, an FDA advisory committee voted that Dynavax had not provided sufficient safety data because of the adjuvant (see BioCentury, Dec. 3, 2012). ...