DBVT - DBV Technologies shares rockets 85% as EMA approves Viaskin Peanut application

The EMA has validated DBV Technologies' (DBVT), +85% Marketing Authorization Application ((MAA)) for its investigational product Viaskin Peanut (DBV712).The validation confirms that the submission is sufficiently complete to begin the formal review process for the non-invasive, once-daily epicutaneous patch to treat peanut allergies in children ages 4 to 11 years. Following the MAA validation, the EMA’s Committee for Medicinal Products for Human Use ((CHMP)) will review the application and provide a recommendation to the European Commission.DBV expects to receive the first set of questions from the EMA ~120 days post-validation. In August 2020, the Company received a Complete Response Letter from the FDA for its BLA for Viaskin Peanut.

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DBV Technologies shares rockets 85% as EMA approves Viaskin Peanut application