Dynavax Technologies Corporation (NASDAQ: DVAX) is off to a rough day in the market today, and for good reason. The FDA has released briefing documents with regard to an upcoming VRBPAC meeting surrounding the potential approval of the company’s Hepatitis B Vaccine. Unfortunately, there is one primary concern that seems to be frightening investors. Of course, our partners at Trade Ideas were the first to alert us to the declines. At the moment (9:11), DVAX is trading at $8.90 per share after a loss of $1.00 per share (10.10%) thus far today.
FDA Releases DVAX Meeting Briefing Documents
As mentioned above, Dynavax Technologies is having a rough day in the market today after the FDA released briefing documents with regard to an upcoming meeting. The meeting, which will take place on July 28th (yes, 2 days away), is a Vaccines and Related Biological Products Committee meeting. This is an open-session meeting designed to discuss the safety and efficacy of HEPLISAV-B, a Hepatitis B Vaccine that DVAX has been working to bring to the market.
However, investors seem to be concerned with regard to some major concerns that the FDA seems to have with regard to the treatment. The main concern here is imbalances in deaths and SAEs of MI as well as imbalances in AESIs. To go through the briefing documents yourself, click here.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on DVAX. In particular, we’re interested in following the progress toward bringing HEPLISAV-B to the market. While we knew that this wasn’t going to be easy given prior denials of DVAX treatments, the meeting on Friday will tell us whether or not this is going to be plausible. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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