Heplisav's salvation

Dynavax Technologies Corp. could soon reap the rewards of persevering with its Heplisav HBV program. It has Phase III data in hand showing superiority to standard of care, a BLA submission planned for year end and a CDC vote this month that would expand the vaccine's market opportunity.

Three years ago, FDA put the Heplisav program on clinical hold after a single case of Wegner's granulomatosis, a disease in which the blood vessels are inflamed, was reported in the Phase III PHAST trial. Later that year, partner Merck & Co. Inc. returned rights...