We are investigating DBV Technologies S.A. (DBVT) (“DBV” or the “Company”) for potential violations of the federal securities laws.
On March 16, 2020, DBV issued a press release disclosing that “the U.S. Food and Drug Administration (FDA) has informed the Company that during its ongoing review of the Biologics License Application (BLA) for investigational Viaskin™ Peanut, it has identified questions regarding efficacy, including the impact of patch-site adhesion.” DBV further advised investors that it “is in communication with the FDA regarding the potential submission of additional information on patch-site adhesion from its clinical program as well as long-term efficacy results from the three-year open-label extension study, PEOPLE, to answer FDA’s questions” and that while the Company “has received no additional information regarding the timeline of the BLA review . . . the submission of additional information to the FDA may constitute a major amendment to the BLA and could extend the target action date.” On this news, DBV’s stock price fell sharply during intraday trading on March 17, 2020.