Dynavax Technologies Corporation (NASDAQ: DVAX)
Dynavax is having an incredible day in the market after announcing the results of its most recent Phase 3 clinical trial. The trial met both co-primary endpoints. Today, we’ll talk about the results of the study, how the market reacted in the news, and what we can expect to see from DVAX moving forward.
DVAX Reports Preliminary Top-line Results
Early this morning, Dynavax Technologies reported preliminary top-line results with regard to the Phase 3 trial of an investigational vaccine for hepatitis B known as HEPLISAV-B. During the study, one group of patients was provided HEPLISAV-B in two doses, one at zero and one at one month. The other group of patients was provided Engerix-B in three doses, one at zero, one at one, and one at six months. During the study, the company was looking for a statistically significant higher rate of seroprotection than that provided by Engerix-B in both diabetic participants and in all participants in the group as well as proving that the vaccine had a strong safety profile. It has been announced that DVAX was able to meet both primary endpoints with the vaccine. In a statement, Eddie Gray, CEO at Dynavax Technologies had the following to say:
“We are delighted to report these topline results from HBV-23 and confirm our intention to resubmit the HEPSLISAV-B BLA by the end of March. These results support our belief that HEPLISAV-B, if approved, could offer benefits to adults at risk for hepatitis B, particularly given that these significant differences in seroprotection were demonstrated in a controlled setting, where compliance is optimized…”
How DVAX Is Reacting To The News
Any time we see positive news with regard to a publicly traded company, we can expect to see gains in the value of that company’s stock. That’s exactly what we’re seeing from DVAX today. Currently (9:34), Dynavax Technologies is trading at $25.27 after a gain of 19.31% so far today.
When Will DVAX Be Submitting HEPLISAV-B To The FDA?
Now that Dynavax has met both of its co-primary endpoints on the Phase 3 trial, it only makes sense that the company will submit a Biologics License Application with the FDA. While the company has submitted a BLA on the drug in the past, the first submission was turned down as the FDA needed more data. However, following the recent study, DVAX should have all of the data that the FDA needs. As a result, we are expecting to see the company resubmit the BLA by the end of the first quarter of 2016. DVAX has already announced that it is anticipating a 6-month review period.
What We Can Expect To See Moving Forward
Moving forward, I have overwhelmingly positive expectations with regard to what we can expect to see from DVAX. While the company’s first BLA on HEPLISAV-B was denied, I believe that the most recent study shows that the vaccine meets all criteria to be approved. Therefore, I’m expecting the submission of the BLA to be a catalyst, followed by approval of HEPLISAV-B acting as another reason for investor excitement. All in all, things are looking up from here.
What Do You Think?
Where do you think DVAX is headed and why? Let us know your opinion in the comments below!
[Image Courtesy of Dynavax]