Dynavax Technologies Corporation (NASDAQ: DVAX) is having an incredibly strong time in the pre-market hours this morning, and for good reason. The company announced that it has received approval from the FDA surrounding a key clinical candidate. Of course, this led to excitement among investors, sending the stock screaming toward the top. Today, we’ll talk about the approval, how the stock reacted to the news, and what we’ll be watching for with regard to DVAX ahead.
DVAX Announces FDA Approval
As mentioned above, Dynavax Technologies Corporation is having an incredibly strong start to the trading session this morning after the company announced that it has received FDA approval. The approval surrounds HEPLISAV-B, the company’s vaccine for the prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 and older. In the press release surrounding the story, DVAX reminded investors that HEPLISAV-B is the first new hepatitis B vaccine in the United States in more than 2 years and is currently the only approved two-dose hepatitis B vaccine for use in adults.
The approval of HEPLISAV-B came as the result of 3 Phase 3 non-inferiority trials that included nearly 10,000 adult participants. When comparing HEPLISAV-B administered in two doses over the course of one month to Engerix-B administered in three doses over six months, the treatment proved a statistically significant higher protection rate. In fact, HEPLISAV-B proved a protection rate of 95% compared to only 81% with Engerix-B. In a statement, William Schaffner, M.D, Professor of Preventative Medicine at Vanderbilt University Medical Center, had the following to offer with regard to HEPLISAV-B by DVAX:
“Prevention of hepatitis B in adults through vaccination is more important than ever given the increase in the rate of infections… Too many at-risk adults remain unprotected against this virus. A two-dose schedule with higher rates of protection, along with other strategies, may help us move closer to the goal of eliminating hepatitis B as a public health problem in the United States.”
The above statement was followed up by Eddie Gray, CEO at DVAX. Here’s what he had to offer:
“HEPLISAV-B is the first FDA-approved product for Dynavax and demonstrates our ability to develop innovative products and progress them from discovery to commercialization… We would like to thank the many study participants and clinical trial investigators who contributed to the development of HEPLISAV-B. We expect that it will become an essential tool in the public health community’s fight to prevent hepatitis B, and we look forward to making HEPLISAV-B available to clinicians and their adult patients.”
How The Stock Reacted To The News
As we’ve come to expect as investors, any time a publicly-traded company releases positive news – especially FDA approval – we can expect to see gains in the value of the stock that represents the company. That’s exactly what we’re seeing from Dynavax Technologies Corporation this morning. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (8:24), DVAX is trading at $22.66 per share after a gain of $2.60 per share (12.99%) thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on DVAX. In particular, we’re interested in following the story surrounding HEPLISAV-B and excited to learn more about the commercialization efforts now that the company has received approval. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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