DBV Technologies S.A. (DBVT) Accused of Misleading Investors About the Efficacy of Its Drug

According to the complaint against the company for alleged violations of the Securities and Exchange Act of 1934 between February 14, 2018 and December 19, 2018, in February 2018, DBV Technologies S.A. (DBVT) announced that the U.S. Food and Drug Administration ("FDA") agreed that the efficacy and safety data for DBV's drug, Viaskin Peanut, supported the submission of a Biologics License Application ("BLA"). In October 2018, DBV stated that the company submitted its BLA, calling it a "significant step forward for those families living with peanut allergy." It came as a surprise to investors when, less than two months later, DBV announced that it voluntarily withdrew its BLA because the FDA determined that the level of detail for manufacturing procedures and quality controls was insufficient. On this news, DBV shares plummeted nearly 60% to close at $5.76 per share on December 20, 2018.

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