FDA's CRL on hepatitis B vaccine spooks Dynavax' shares

14 November 2016

Shares of US clinical-stage biopharma firm Dynavax Technologies (Nasdaq: DVAX) took a 63% nosedive in Monday morning’s trading after bad news on its hepatitis B vaccine.

Chief executive Eddie Gray admitted that the company might not be able to advance Heplisav-B (hepatitis B vaccine, recombinant (adjuvanted)) alone and quickly needed to find a partner to continue the program, after the receipt of a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA).

The CRL, relating to Dynavax’s Biologics License Application for Heplisav-B, seeks information regarding several topics, including clarification regarding specific adverse events of special interest (AESIs).

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