Acer Therapeutics Inc.

On June 25, 2019, the Company revealed a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration regarding its marketing application for EDSIVO, a medication for the treatment of Ehlers-Danlos syndrome. According to the CRL, “an adequate and well-controlled trial” was required to determine whether EDSIVO “reduces the risk of clinical events” in patients with vascular Ehlers-Danlos syndrome.

On this news, the Company’s share price fell $15.16, or nearly 79%, to close at $4.12 on June 25, 2019, thereby injuring investors.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) Acer lacked sufficient data to support filing EDSIVO’s NDA with the FDA for the treatment of vEDS; (2) the Ong Trial was an inadequate and ill-controlled clinical study by FDA standards, and was comprised of an insufficiently small group size to support EDSIVO’s NDA; (3) consequently, the FDA would likely reject EDSIVO’s NDA; and (4) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.