DBV Technologies (DBVT) Stock Rockets On Peanut Allergy Treatment News

DBV Technologies DBVT Stock News

DBV Technologies ADR (NASDAQ: DBVT) is making a run for the top in the market this morning, and for good reason. The company announced that it has submitted and received validation for a marketing application for a peanut allergy treatment in Europe. Here’s what’s going on:

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DBVT Stock Heads Up On Peanut Allergy Treatment Application

In the press release, DBV Technologies said that its Marketing Authorization Application, or MAA, for Viaskin has been validated by the European Medicines Agency, or EMA. Viaskin is the company’s investigational non-invasive, once-daily patch to treat peanut allergies. In particular, the treatment is being developed as an option for children ages 4 to 11.

The EMA is much like the FDA in the United States. With the application validated, the next step is for the Committee of Medical Products for Human Use, or CHMP, will review the applications an provide a recommendation to the European Commission.

This recommendation will hold incredible weight when it comes to the decision to either grant or deny marketing authorization, which would make the treatment available in Europe. DBVT said that it expects for the first set of questions to come from the EMA within the next 120 days.

DBVT reminded investors that it received a Complete Response Letter from the FDA for a Biologics License to market Viaskin Peanut in the United States. The company said that it continues to work with the FDA with regard to a regulatory path forward.

This Is Big News

The news released by DBV Technologies is overwhelmingly positive. At the moment, there are no treatments on the market to prevent peanut allergic reactions. The only option is to treat the reaction once it happens. If Viaskin Peanut is approved in Europe, it will likely become a blockbuster.

Moreover, the company is continuing to work with the FDA to bring the treatment to the United States as well, only expanding the opportunity here. All in all, DBVT stock is one to watch closely.

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