Dynavax (DVAX) PT Cut to $4 at RBC Following CRL
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Dynavax (DVAX) Receives FDA Complete Response Letter for HEPLISAV-B BLA in HBV
November 14, 2016 6:31 AM ESTDynavax Technologies Corporation (Nasdaq: DVAX) announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for HEPLISAV-B [Hepatitis B Vaccine, Recombinant (Adjuvanted)] for immunization of adults 18 years and older against hepatitis B infection. The FDA issues CRLs to communicate that the Agency has completed a review cycle of an application and to request additional information for review and approval. Dynavax expects a Class 2 designation for a resubmission of the BLA, which would result in a target review... More
