Acer Therapeutics Inc. (ACER) Accused of Misleading Investors
According to the filed complaint for alleged violations of the Securities Exchange Act of 1934 between September 25, 2017 and June 24, 2019, in December 2016, Acer Therapeutics Inc. (ACER) announced that it obtained exclusive rights to New Drug Application (“NDA”)-enabling clinical data from the Assistance Publique—Hôpitaux de Paris’ Ong Trial for the use of EDVISO in treating vascular Ehlers-Danlos Syndrome (“vEDS”). Throughout the relevant period, Acer touted the robust results from the Ong Trial and assured that it would support Acer’s NDA for EDVISO. However, these assurances were materially false and misleading as they failed to disclose that the Ong Trial did not meet FDA standards and therefore Acer lacked sufficient data to support filing EDVISO’s NDA. This became evident in June 2019, when Acer revealed that the FDA needed it to “conduct an adequate and well-controlled trial” to determine EDVISO’s effects in patients. A news source then reported that the small group size of the Ong Trial had raised questions about the adequacy of EDVISO. On this news, Acer’s stock price fell $15.16 per share, or over 75% to close at $4.12 per share. The stock currently trades at $2.63 per share.