FDA Rejects Dynavax Hepatitis B Vaccine Again

Nov. 15, 2016

Dynavax Technologies Corporation has seen its stock plummet after the U.S. Food and Drug Administration rejected the company's hepatitis B vaccine for the second time in three years in a Complete Response Letter (CRL) posted to their website.

"The CRL is consistent with our opinion that HEPLISAV-B is approvable and we are seeking to meet with the FDA as soon as possible," said Eddie Gray, chief executive officer of Dynavax. "However, the time and resources that will be required to gain approval leads us to consider that we may not be able to advance this program on our own and we are moving swiftly to identify a potential pharmaceutical or financial partner. We will maintain our efforts on the oncology programs, including our lead cancer immunotherapy candidate, SD-101, for which we recently announced encouraging early clinical data in metastatic melanoma."

Dynavax shares have cratered by as much as 72 percent to $3.20, the lowest since 2008. The company had an earlier marketing application for the vaccine, Heplisav-B, rejected in February 2013. But a late-stage study in January showed positive signs, leading Dynavax to its latest resubmission.

According to the company, the FDA made no requests for additional clinical trials and there were no apparent concerns about rare serious events. Dynavax expects the review period for resubmission to be six months.