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FDA rejects Dynavax's HEPLISAV-B marketing application; shares plummet 74% premarket

Published 11/14/2016, 08:09 AM
FDA rejects Dynavax's HEPLISAV-B marketing application; shares plummet 74% premarket
DVAX
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  • Dynavax Technologies (NASDAQ:DVAX) craters 74% premarket on robust volume in response to its announcement that it has received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) seeking approval of HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for immunization of adults at least 18 years old against hepatitis B virus (HBV) infection.
  • The CRL requests clarification regarding specific adverse events of special interest (AESIs) and a numerical imbalance in a small number of cardiac events in the HBV-23 study. It also cites the need for new analyses of the integrated safety database across different time periods and post-marketing commitments.
  • The agency stated that it had not yet completed its review of the company's responses received in early October that included the AESIs and the numerical imbalance in cardiac events. Dynavax says its responses included an extensive analysis that supports its view that the imbalance was due to an unexpectedly low number of events in the comparator arm.
  • The CRL did not specify the need for additional clinical trials nor any concerns with rare serious autoimmune events.
  • The company plans to meet with the agency as soon as possible.
  • Previously: TheStreet's Feuerstein says Ad Comm cancellation by FDA bodes ill for Dynavax's HEPLISAV-B; shares slump 10% (Oct. 4)

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