Dynavax Technologies Corp. (DVAX) announced on Tuesday that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its supplemental Biologics License Application for including a four-dose Heplisav-B vaccine regimen for hemodialysis patients.
According to the company, the FDA indicated that the application lacked sufficient data to fully evaluate the treatment's effectiveness and safety. This shortfall was due to the destruction of several data source documents by a third-party clinical trial site operator. Additionally, the FDA noted that the participant count in the trial was too low to properly assess the treatment's safety.
Despite this setback, Dynavax emphasized that the CRL does not impact the currently approved indications for the Heplisav-B vaccine in the U.S., European Union, and Great Britain.
As of now, Dynavax's share price has declined by 1.27 percent, reaching $10.89 on the Nasdaq.