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Dynavax plummets after Ad Comm review of hep B vaccine canceled; shares down 32%

  • Dynavax (DVAX -31.7%) gets some rude treatment today. Shares are down on a 29x surge in volume on the news that the FDA has canceled the November 16 Ad Comm review of the company's BLA seeking approval of its hepatitis B vaccine, Heplisav-B.  The agency says it needs more time to "review and resolve several outstanding issues."
  • Previously: Dynavax's hepatitis B candidate gets Ad Comm review Nov. 16 (Aug. 5)
  • Update: On September 6, the company issued a statement saying the FDA intends to provide information requests in the coming weeks. The agency indicated that it will review the overall immunogenicity data from the Phase 3 HBV-23 study to support the proposed adult indication but it will not review immunogenicity data related to sub-populations including diabetics because the data were not a direct response to its February 23, 2013 Complete Response Letter (CRL). A Class 2 resubmission, which is what this is, relates only to the issues cited in the CRL. Additional data will need to be submitted as a supplemental BLA following approval. The company says the FDA has communicated that the December 15 PDUFA date should still be achievable.

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