Look back at pharma news to Sept 9

11 September 2016

By Barbara Obstoj-Cardwell. Editor

Shares of Dynavax Technologies were jumping 24.29% to $13.56 on heavy trading volume mid-Tuesday morning as investment bank William Blair said the US Food and Drug Administration’s cancellation of a November 16 Vaccines and Related Biological Products Advisory Committee meeting for the company's hepatitis B vaccine Heplisav is a net positive.

Dynavax said in a statement this weekend that although the November advisory meeting was cancelled, a December 15 PDUFA meeting is still scheduled. William Blair added that the agency's decision to go right to the PDUFA date suggests that the drug is "sufficiently strong and adequate to warrant approval in the absence of a panel," according to a note cited by the Fly.

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