3:11 PM
Jul 28, 2017
 |  BC Extra  |  Company News

FDA panel backs Heplisav-B, wants rigorous postmarketing study

Editor's Note: This article was updated on Aug 04, 2017 at 5:20 PM PDT

Dynavax Technologies Corp. (NASDAQ:DVAX) jumped $7.45 (81%) to $16.70 in after-hours trading on Friday after FDA's Vaccines and Related Biological Products Advisory Committee voted 12 to one, with three abstentions, that available safety data support the use of the company's HBV vaccine Heplisav-B in adults. The committee also stressed the importance of a well-designed postmarketing study to assess observed imbalances in cardiovascular events. Heplisav-B's PDUFA date is Aug. 10.

The reviewers were concerned with imbalances...

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