Dynavax initiates Phase 3 study of HEPLISAV-B Dynavax Technologies announced initiation of a new phase 3 clinical trial of HEPLISAV-B, its investigational adult hepatitis B vaccine. This large safety and immunogenicity study, known as HBV-23, was designed to address the Complete Response Letter regarding the HEPLISAV-B Biologics License Application that was issued to Dynavax by the FDA in February, 2013. HBV-23 will provide greater clarity regarding the safety profile of HEPLISAV-B by significantly expanding the overall database of vaccinated subjects. The study will also assess the immunogenicity of HEPLISAV-B in subjects for whom approved hepatitis B vaccines are less effective. Dynavax expects that all study subjects will be enrolled by the end of 2014 and all follow-up will be completed by 4Q15.
Dynavax upgraded to Overweight from Neutral at JPMorgan JPMorgan upgraded Dynavax to Overweight saying it is now "significantly more comfortable" with the safety of the company's Heplisav vaccine for hepatitis B. The firm raised its price target for shares to $36 from $15.