Dynavax Technologies Corp. (NYSE:DVAX) shares jumped 88% in premarket trade Monday after a US Food and Drug Administration (FDA) advisory committee said the safety data for its Hepatitis B vaccination supported its approval.
The advisory committee voted 12 to 1 on the safety data, with three members abstaining.
A previous advisory committee had voted 13 to 1 in favor of the vaccine's ability to promote an immune response.
On Monday, Dynavax was upgraded to overweight at J.P. Morgan with a US$27 price target and upgraded to outperform at RBC Capital Markets with a US$26 price target.
Although there are already Hepatitis B vaccines in the market, they require three doses administered over six months, while Dynavax's HEPLISAV-B vaccine only requires two doses over a month period, the company said.
An FDA decision on the approval of the vaccine is expected by August 10.
Dynavax said should the vaccine be given the green light, it will seek a recommendation from the CDC's immunization practices advisory committee.
The company plans a commercial launch of the vaccine in early 2018 "on its own or through a commercial partner."
Dynavax shares have surged 88.11% to $17.40 in premarket trade and then later gained 76% to $16.37 each.