Dynavax (DVAX) shares were lower Monday after U.S. regulators rejected the company's application to market preventative hepatitis B vaccine Heplisav-B. The drugmaker also said it will need assistance from other pharmaceutical companies or financial partners to resubmit Heplisav-B for another shot at approval. In October, the U.S. Food and Drug Administration nixed a proposed advisory panel scheduled for November, which would have reviewed the Heplisav-B efficacy and safety data. The meeting cancellation initially prompted Dynavax investors to sell shares at that time amid concerns the FDA was leaning towards rejecting the application.
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