Why DBV Technologies shares jumped today
Shares of DBV Technologies ( DBVT 1.37% ), a clinical-stage biotech company based in France, surged Friday and rose 41.2% as of 11:34 a.m. EST after rising 49.7% earlier in the day. The catalyst for these gains is a regulatory update provided by the company regarding its potential treatment for peanut allergy, Viaskin Peanut.
Viaskin Peanut is a patch that can desensitize the immune system of patients by exposing them to peanut protein. But due to concerns about the effect of patch adhesion on its effectiveness, the US Food and Drug Administration (FDA) has not approved Viaskin Peanut. In October, DBV Technologies requested a Type A meeting with the regulator to discuss the way forward. Type A meetings are used to resolve issues that have stalled the development of a drug.
On Thursday evening, DBV Technologies said comments received from the FDA at this meeting “provide a well-defined regulatory pathway” for Viaskin Peanut. Specifically, the company has elected to create a modified Viaskin Peanut patch, which will not be considered a new product entity. The FDA recommended that DBV Technologies conduct a safety and adherence trial to evaluate the modified Viaskin Peanut patch. The company said it will submit the protocol for this study to the FDA for review in the second quarter before starting the trial.
There’s still a long way to go for DBV Technologies and Viaskin Peanut in the US, but the FDA deal is a much better option than having to scrap the program altogether. Also, in November, the biotechnology company announced that it has submitted Viaskin Peanut for approval in Europe. If all goes well for the company, its peanut allergy treatment could hit the market in the United States and Europe within a few years.
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