- Dynavax (NASDAQ:DVAX +4.9%) says its biologics license application for hepatitis B vaccine Heplisav-B is headed for an Advisory Committee meeting on Nov. 16.
- The vaccine candidate is under review with a Prescription Drug User Fee Act action date of Dec. 15.
- The FDA will communicate questions for its Vaccines and Related Biological Products Ad Comm to review closer to the meeting date.
- Heplisav-B combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response, Dynavax says. It's administered in two doses over one month.