- Dynvax (NASDAQ:DVAX) issued a statement on September 4 saying the FDA intends to provide information requests in the coming weeks related to its review of the company's Biologics License Application (BLA) seeking approval of HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)].
- 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.
- DVAX shares plummeted last Friday on the news that the FDA canceled its Ad Comm review of the BLA saying it needed more time to "review and resolve several outstanding issues."
- Previously: Dynavax plummets after Ad Comm review of hep B vaccine canceled; shares down 32% (Sept. 2)