FDA cancels Dynavax advisory meeting

Dynavax Technologies Corp. (NASDAQ:DVAX) plunged $5.03 (32%) to $10.91 on Friday after FDA canceled a Nov. 16 meeting of its Vaccines and Related Biological Products Advisory Committee to discuss a BLA for HBV vaccine Heplisav-B. The agency said the meeting was canceled "to allow time for FDA to review and resolve several outstanding issues." Dynavax did not respond to inquiries.

In April, FDA extended the BLA's PDUFA date to Dec. 15 from Sept. 15 after Dynavax submitted individual trial data sets. ...