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 "novel adjuvants" may cause rare autoimmune events. The company, which said the agency "indicated its willingness to continue discussions" for a more restricted use of Heplisav, said it plans to meet with FDA in the next six weeks.
On a conference call to discuss the letter, Dynavax said it plans to seek approval in a narrower population, which may not require an additional trial. The company said narrower indications for Heplisav may include patients with chronic kidney disease (CKD) and adults over 40 years of age. Dynavax had originally sought approval for Heplisav to prevent HBV infection in adults ages 40 and up, but last February agreed with FDA to expand the age range of the proposed indication to adults 18-70 years of age. ...