Dynavax Technologies Corporation (NASDAQ: DVAX) is off to an incredibly rough start in the pre-market hours this morning, and for good reason. The company announced news it received from the FDA. Unfortunately, this news proved to be concerning to investors. Of course, this led to declines, prompting our partners at Trade Ideas to alert us to the fall. Currently (7:44), DVAX is trading at $16.05 per share after a loss of $0.95 per share (5.59%) thus far today.
DVAX Falls On FDA News
As mentioned above, Dynavax Technologies isn’t having the best of days in the market today. In fact, the stock is finding its way toward the bottom as FDA news hits investors. The company announced late yesterday that the United States Food and Drug Administration has requested more information with regard to the proposed post-marketing study for HEPLISAV-B, the company’s hepatitis B vaccine.
As a result of the information request, the FDA and DVAX now have up to 3 months to agree on a the post-marketing study prior to the updated PDUFA date, which is now November 10, 2017. In a statement, Eddie Gray, CEO at DVAX, had the following to offer:
“Our conversation with the Agency was open and productive and confirmed our mutual understanding of the VRBPAC’s suggested requirements for the post-marketing study. We are working with our third-party providers to develop an appropriate study that addresses the advisory committee’s feedback. We now have clarity on the path forward and next steps required to complete the regulatory review of HEPLISAV-B… We plan to respond to the request for additional information expeditiously. We look forward to bringing this important vaccine to market to support the elimination of hepatitis B infection as a public health problem.”
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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 ongoing work surrounding HEPLISAV-B. We’ll continue to follow the story closely and bring the news to you as it breaks!
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