DBV Technologies SA – ADR (NASDAQ: DBVT) is having an overwhelmingly strong day in the market today, and for good reason. The company announced a regulatory update that’s leading to excitement among investors, sending the stock screaming for the top. Today, we’ll talk about the news, what we’re seeing from DBVT, and what we’ll be watching for ahead.
DBVT Gains On Regulatory Update
As mentioned DBV Technologies is having an overwhelmingly strong day in the market today after announcing a regulatory update. In a press release issued early this morning, the company announced that the United States Food and Drug Administration, or FDA, has agreed that the available efficacy and safety data for its proprietary Vaskin Peanut supports the submission of a Biologics License Application, or BLA. The data supports the BLA for the treatment of peanut allergy in children from age 4 to age 11.
In the release, DBVT said that the FDA provided written responses to the clinical pre-BLA meeting package that the company submitted. These written responses reflected agreement with regard to the content of the clinical module of the BLA for Viaskin Peanut. As a result, the company said that it remains on track to submit the BLA for the treatment in the second half of 2018. In a statement, Dr. Pierre-Henri Benhamou, Chairman and CEO at DBVT, had the following to offer:
We are pleased with this positive step forward in our progress towards potential approval of Viaskin Peanut, and appreciate the feedback we received from the FDA supporting submission of our BLA… There are approximately one million children in the U.S. diagnosed with this life-threatening disease, and we look forward to continue working with the agency to address this urgent unmet medical need.
What We’re Seeing From The Stock
As investors, one of the first lessons we learn is that the news moves the market. In the space of biotechnology, there are few bits of news that have the ability to cause movement quite like regulatory news. With the positive feedback from the FDA to DBV Technologies, it’s no surprise that investors are excited and sending the stock soaring today. As is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:49), DBVT is trading at $25.88 per share after a gain of $5.01 per share or 24.04% 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 DBVT. In particular, we’re interested in following the company through the submission and review of their BLA. Considering the data surrounding Viaskin Peanut, the treatment has a high chance of approval, so there is likely a strong catalyst ahead. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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