DBV Technologies S.A. (NASDAQ: DBVT) shares absolutely exploded on Monday after the firm announced that the Marketing Authorization Application (MAA) for its peanut allergy treatment was validated by the European Medicines Agency (EMA).
Specifically, the MAA is for its investigational product Viaskin Peanut (DBV712). The validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. The EMA’s Committee for Medicinal Products for Human Use (CHMP) will review the application and provide a recommendation to the European Commission (EC) on whether to grant a marketing authorization.
Looking ahead, DBV expects to receive the first set of questions from the EMA roughly 120 days post-validation.
Separately, DBV Tech mentioned that it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) back in August 2020 for its Biologics License Application (BLA) for investigational Viaskin Peanut. The company is in the process of engaging FDA to discuss the regulatory path forward.
Previously, the FDA has 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. The FDA also has indicated that supplementary clinical data would need to be generated to support the modified patch. Additionally, the FDA requested additional Chemistry, Manufacturing and Controls data. Note that the FDA did not raise any safety concerns related to Viaskin Peanut.
Excluding Monday’s move, DBV Tech had vastly underperformed the broad markets with its stock down 87% year to date. In the past 52 weeks, the stock was down closer to 80%.
DBV Technologies stock was last seen up 65% at $2.36, in a 52-week range of $1.35 to $13.49. The consensus price target is $6.25.