FDA panel to discuss Dynavax's Heplisav-B

Dynavax Technologies Corp. (NASDAQ:DVAX) said FDA's Vaccines and Related Biological Products Advisory Committee will meet Nov. 16 to discuss its BLA for Heplisav-B. The candidate is under review to prevent HBV infection in adults, with a Dec. 15 PDUFA date.

In 2013, FDA issued a complete response letter for the vaccine requesting additional safety data. In January, Dynavax said Heplisav-B met the co-primary endpoints in a Phase III study, including a safety endpoint. ...