Dy­navax shares crater af­ter the FDA re­jects Hep­lisav-B, again, and CEO sig­nals for help

Shares of Dy­navax head­ed south Mon­day morn­ing af­ter the biotech no­ti­fied in­vestors that the FDA has re­ject­ed its ap­pli­ca­tion to mar­ket the he­pati­tis B vac­cine Hep­lisav-B.

Dy­navax {DVAX} made it clear that the agency has not asked for any new tri­als and seems to be sig­nal­ing that it needs more time to as­sess new in­for­ma­tion on the drug that has al­ready been sub­mit­ted. But af­ter a year of ups and downs on this pro­gram, and an ini­tial re­jec­tion dat­ing back three years, the biotech says it needs to sign up a part­ner to help get this vac­cine over the fin­ish line and in­to the mar­ket.

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