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Dynavax's hepatitis B candidate gets Ad Comm review Nov. 16

  • 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.

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