Shares of Dynavax Technologies (NASDAQ:DVAX) were jumping 5.9% higher as of 3:09 p.m. EST on Friday. The gain came after the company announced that its hepatitis B virus (HBV) vaccine Heplisav-B received marketing authorization from the European Commission (EC).
Today's news wasn't really a surprise. The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) already gave a positive approval recommendation. Heplisav-B is also already approved in the U.S.
However, the announcement removed one more hurdle for Dynavax. Its HBV vaccine is now approved throughout all 28 countries in the European Union (EU). The EC marketing authorization is also valid in Iceland, Liechtenstein, and Norway, which aren't members of the EU.
The regulatory authorization will greatly expand Dynavax's potential market. There are over 250 million people infected with HBV worldwide. Around 15 million of those individuals live in Europe.
Dynavax expects to launch Heplisav-B in Europe later this year. The next potential catalyst for the biotech stock, though, could be only a few days away. Dynavax is scheduled to announce its fourth-quarter and full-year 2020 results on Feb. 25.