Summary of DVAX ph3 PR

The bolded section is not good.. thus the selloff


"With respect to the consistency analysis of three consecutively manufactured lots of HEPLISAV, Dynavax concluded that the study had demonstrated consistency based on the complete immunogenicity data demonstrated by the three vaccine lots over the six months following second immunization.

By Geometric Mean Antibody Concentration (GMC), the results met the pre-specified consistency criteria at 12, 18, 24 and 28 weeks, but not at 8 weeks, the pre-specified primary endpoint. The GMC of one HEPLISAV lot was slightly higher than the other two lots, which resulted in not meeting the consistency criteria at week 8.
By SPR, the results met the pre-specified consistency criteria at 12, 18, 24 and 28 weeks, but not at 8 weeks.
At all of these timepoints, each lot of HEPLISAV was superior to Engerix-B."