Dynavax Technologies Corporation (NASDAQ: DVAX)
Dynavax Technologies is having an incredible day in the market today, and for good reason. Early this morning, the company announced that it has received anticipated requests from the US FDA for more information with regard to a vaccine. Today, we'll talk about the news, what we're seeing from the stock as a result, and what we can expect to see from DVAX ahead. So, let's get right to it...
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DVAX Gains On FDA News
As mentioned above, Dynavax Technologies is having a strong day in the market today after an SEC filing showed that the company has received anticipated requests for more information from the FDA. The request surrounds the company's pending Biologics License Application for HEPLISAV-B. HEPLISAV-B is a vaccine that the company has designed to help in the prevention of Hapatitis B infections.
The requests received by DVAX were right in line with what the company expected to see. As a result, the company is more than prepared to work with the FDA in order to resolve questions surrounding the Biologics License Application. It is expected that the FDA will either approve or reject the vaccine by no later than the PDUFA date of December 15th, 2016.
The filing that DVAX submitted to the SEC contained several forward-looking statements. Of course, these statements included interactions with the FDA and the status of the HEPLISAV-B BLA that is currently under FDA review. To read the full list of statements offered in the SEC filing, click here.
What We're Seeing From The Stock As A Result
As investors, one of the first things that we learn is that the news moves the market. Of course, positive news leads to gains while negative news generally leads to declines. In this particular case, the news that was released with regard to Dynavax was overwhelmingly positive. The company received further requests from the FDA that it had already been anticipating. So, they should have no problem responding to these requests in a timely fashion, leading to a higher chance of an approval by the PDUFA date. As a result of the overwhelmingly positive news, we're seeing strong gains in the value of the stock today. Currently (12:12), DVAX is trading at $12.60 per share after a gain of $2.11 per share (20.11%) thus far today.
What We Can Expect To See Moving Forward
Moving forward, I have an overwhelmingly bullish opinion of what we can expect to see from Dynavax Technologies. At the end of the day, the company is closer now to its Biologics License Application being approved. Of course, approval of this application would allow the company to license the vaccine, bring it to the market, and generate revenue. All in all, things are looking great.
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However, it is important to remember the risks when trading DVAX or any stock like it. At the end of the day, the stock is heavily dependent on this approval, and while chances are looking great, the FDA has a history of surprising investors. If the vaccine is not approved, we're likely to see massive declines in the value of the stock. However, once again, I believe that the chances of approval are far higher than the chances of rejection in this particular case.
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