The FDA on Friday said it cancelled an advisory panel meeting for Dynavax Technologies investigational hepatitis B vaccine Heplisav-B, sending shares in the drugmaker down as much as 36 percent. The agency noted that the meeting was cancelled to permit it to "review and resolve several outstanding issues."
The FDA initially set a date of November 16 for the advisory panel meeting last month. The agency indicated that it will continue to evaluate Heplisav-B internally and schedule another meeting if needed.
The FDA accepted Dynavax's submission seeking approval of Heplisav-B for immunisation against hepatitis B virus infection in adults in March. The regulator later extended its review of the vaccine by three months to December 15 after Dynavax submitted individual trial data sets in line with an agency request.
In January, Dynavax reported that a Phase III study of the therapy met both of its co-primary endpoints versus GlaxoSmithKline's Engerix-B. For related analysis, read ViewPoints: The little HBV vaccine that could – new data may finally vindicate Dynavax’s Heplisav.
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