Today, shares of Dynavax Technologies (DVAX) soared 40% after the company reported that it had obtained positive phase 3 results for its Hepatitis B trial. This phase 3 trial looked at both safety and immunogenicity of the company's vaccine, known as Heplisav-B. Immunogenicity means how well a substance, in this case Heplisav-B, can generate an immune response within the patient's body. 

The phase 3 trial compared Heplisav-B to an already marketed Hepatitis B vaccine known as Engerix-B by GlaxoSmithKline (GSK). The primary endpoint of the study was to determine non-inferiority of seroprotection in patients with Diabetes Mellitus. Heplisav-B obtained a seroprotection rate of 90% compared to only 65.1% for Engerix-B. 

In addition Heplisav-B in the entire group obtained a seroprotection rate of 95.4% compared to Engerix-B only obtaining 81.3%. That means that Dynavax's vaccine met on both co-primary endpoints, and that's why the stock was sent higher today. Safety was good, as observed from previous trials using Heplisav-B. 

With this data in hand, the company now expects to resubmit its Biologics License Application -- BLA -- to the FDA for approval by the end of the first quarter of 2016. Once fully submitted, the FDA will take about six months to decide whether or not to approve the BLA. Dynavax will also submit previous clinical trial data on top of this new HBV-23 trial data. This should potentially address the concerns of the FDA from the Complete Response Letter -- CRL -- back in Feb of 2013.