Dy­navax shares slide as FDA re­view spot­lights a hazy safe­ty is­sue for Hep­lisav

About 8 months af­ter the FDA re­ject­ed Dy­navax’s hep B vac­cine Hep­lisav, the biotech is once again un­der scruti­ny at the agency.

And one more time, FDA re­view­ers are ze­ro­ing in on the vac­cine’s safe­ty pro­file as it preps an­oth­er mar­ket­ing de­ci­sion for this long-de­layed ef­fort.

Last No­vem­ber the FDA said it wasn’t able to prop­er­ly as­sess ad­di­tion­al de­tails on the ad­verse events — par­tic­u­lar­ly an im­bal­ance in the car­diac events that reg­u­la­tors were fret­ting over. In an in­ter­nal re­view ahead of Fri­day’s pan­el dis­cus­sion on Hep­lisav, reg­u­la­tors say that while it is clear that there is an im­bal­ance in deaths and car­diac events, the num­ber they’re talk­ing about is small and hard to read.

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