Dynavax slumps as FDA cancels advisory panel meeting to resolve issues with Heplisav-B

US clinical-stage biopharma firm Dynavax Technologies (Nasdaq: DVAX) saw its shares drop 31.6% to $10.91 on Friday after the Food and Drug Administration's Center for Biologics Evaluation and Research cancelled the scheduled November 16, 2016, Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the Biologics License Application (BLA) for Heplisav-B (hepatitis B vaccine, recombinant [adjuvanted]).

During recent conversations between Dynavax and the FDA, the agency communicated decisions to enable compliance with the current Prescription Drug User Fee Act (PDUFA) date of December 15, 2016, said Dynavax. The FDA informed Dynavax that the VRBPAC meeting was cancelled and remaining questions will be addressed between Dynavax and the review team via the normal process. The FDA informed Dynavax that it plans to provide information requests related to remaining questions in the upcoming weeks. Dynavax is prepared to address these questions expeditiously in order to enable the FDA to complete its review as soon as possible.

"Our dialogue with the FDA has been very open and productive, and we look forward to providing the review team with any additional information they may need to complete their review," said Eddie Gray, chief executive of Dynavax, adding: "We are committed to bringing Heplisav-B to market as we believe it offers a better level of protection than the currently available hepatitis B vaccines."