FDA calls for more info on Dynavax' Heplisav

Dynavax Technologies has received a communication from the US Food and Drug Administration regarding the clinical hold on the two Heplisav  Investigational New Drug applications, for healthy adults and patients  with end-stage renal disease). In this, the FDA has requested additional  clinical and safety information which the agency indicated may be  helpful in its risk assessment of the two INDs and may assist in finding  a development path forward for the firm's hepatitis B vaccine, not only  in ESRD patients but also in healthy adults.