DBV Technologies (DBVT) - Get DBV Technologies S.A. Report was skyrocketing Monday after the biotech company said its marketing authorization application for Viaskin Peanut, its peanut-allergy patch, had been validated by the European Medicines Agency.
American depositary receipts of the French company were soaring 45% to $2.08 each.
"The validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process for the investigational non-invasive, once-daily epicutaneous patch to treat peanut allergies in children ages 4 to 11 years," the company said in a statement.
DBV said it expects to receive the first set of questions from the EMA regarding marketing approval about 120 days post-validation.
Following the MAA validation, DBV said, the EMA’s Committee for Medicinal Products for Human Use will review the application and provide a recommendation to the European Commission on whether to grant a marketing authorization.
In August, the Food and Drug Administration rejected the company's filing for Viaskin Peanut. In its letter, the FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor study.
DBV said that it "is in the process of engaging the FDA to discuss the regulatory path forward."
Bryan Garnier analyst Jean-Jacques Le Fur said this earlier-than-expected filing strategy could be “a good way for DBV to push the FDA to agree on the remediation plan it will propose to the FDA,” Bloomberg reported, since the European market for peanut allergies is only about a third the size of the U.S.
DBV Technologies has global headquarters in Montrouge, France and offices in Bagneux, France, and North American operations in Summit, N.J. and New York City.