5:32 PM
Feb 25, 2013
 |  BC Extra  |  Company News

Dynavax receives Heplisav complete response

Dynavax Technologies Corp. (NASDAQ:DVAX) fell $0.96 (32%) to $2.01 on Monday after FDA issued a complete response letter for a BLA for its Heplisav adjuvanted HBV vaccine. According to the company, FDA said it could not approve Heplisav in adults 18-70 years of age without further safety evaluation, and the agency also continued to express concern that...

Read the full 278 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury Extra

Article Purchase

$35 USD
More Info >