Shares of DBV Technologies (DBVT 2.94%) were trading higher on Friday following the company's release of its full-year 2020 earnings report. Much more important than its financial results, however, the company provided encouraging regulatory updates. As of 3:27 p.m. EST today, the stock was up by 13.2%.
DBV Technologies is developing Viaskin Peanut, a potential peanut allergy treatment. Viaskin Peanut is a "peanut patch" that can stimulate a patient's immune system by gradually exposing the patient to increased amounts of peanut protein. The company submitted Viaskin Peanut for review to the Food and Drug Administration in August 2019. But in August 2020, the agency declined to approve the treatment because of concerns surrounding the effect of patch adhesion on its efficacy.
Thankfully, after a Type A meeting with the FDA (to resolve issues to allow the development of a drug to move forward), DBV Technologies said it would create a modified Viaskin Peanut patch that would not be considered a new product. Per the FDA's recommendation, the company would need to conduct safety and adhesion trials on the new patch.
Today, DBV Technologies announced that it has started a trial on healthy adult volunteers to test the adhesion of five modified Viaskin Peanut patches. The company's goal is to identify the best of the bunch. It said that all participants should complete the trial by March.
Investors can now clearly see a path forward for Viaskin Peanut in the U.S. market, which is excellent news for the company; it was probably the main catalyst behind DBV Technologies' gains on the stock market today. Of note, the healthcare company also submitted Viaskin Peanut for review in Europe back in November. Regulatory authorities there have not raised concerns regarding patch adhesion on Viaskin Peanut's efficacy.
If all goes well for DBV Technologies, the company could launch this product in both the U.S. and EU markets within the next couple of years or so.