RADNOR, Pa.--(BUSINESS WIRE)--The law firm of Kessler Topaz Meltzer & Check, LLP reminds Acer Therapeutics, Inc. (Nasdaq: ACER) (“Acer”) investors that a securities fraud class action lawsuit has been filed on behalf of those who purchased or otherwise acquired Acer securities between September 25, 2017 and June 24, 2019, inclusive (the “Class Period”).
REMINDER: Investors who purchased Acer securities during the Class Period may, no later than August 30, 2019, seek to be appointed as a lead plaintiff representative of the class. For additional information or to learn how to participate in this litigation please visit www.ktmc.com/acer-therapeutics-inc-securities-class-action.
According to the complaint, Acer is a pharmaceutical company that focuses on the acquisition, development, and commercialization of therapies for serious rare and life-threatening diseases. Acer’s pipeline includes, inter alia, EDSIVO (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (“vEDS”) in patients with a confirmed type III collagen mutation. vEDS is a rare disease known to cause abnormal fragility in blood vessels, causing aneurysms, arteriovenous fistulas, arterial dissections, and spontaneous vascular ruptures, all of which are potentially life-threatening. In 2004, the French research hospital, Assistance Publique—Hôpitaux de Paris, Hôpital Européen Georges Pompidou (“AP-HP”), published data on vEDS patients. Based on AP-HP’s research, investigators began assessing the preventive effect of celiprolol for major cardiovascular events in patients suffering from vEDS “through a multicenter, prospective, randomized, open trial with blinded evaluation of clinical events” (the “Ong Trial”). The Ong Trial was composed of fifty-three participants “randomized at eight centers in France and one center in Belgium.” On December 13, 2016, Acer Therapeutics Inc. (“Private Acer”) – a private Delaware corporation and Acer’s predecessor – issued a press release announcing that it had signed an agreement with AP-HP, which granted exclusive rights to access and use data from the Ong Trial. Private Acer announced it would use this data to support its New Drug Application (“NDA”) for celiprolol in the treatment of vEDS.
The Class Period commences on September 25, 2017, when Acer issued a press release announcing “Positive Results From Pivotal Clinical Trial of EDSIVO” for the treatment of vEDS.
According to the complaint, on June 25, 2019, Acer issued a press release disclosing that the U.S. Food and Drug Administration (“FDA”) rejected Acer’s NDA for EDSIVO. The press release cited the need for an “adequate and well-controlled trial” evaluating EDSIVO’s effectiveness in reducing the risk of clinical events in patients with vEDS. That same day, Reuters published an article titled “FDA declines to approve Acer Therapeutics’ rare genetic disorder treatment.” In discussing the FDA’s rejection of Acer’s NDA, the article noted how “[t]he small group size” of the Ong Trial had “raised questions among experts about the adequacy of the trial results.” Following this news, Acer’s stock price fell $15.16 per share, or 78.63%, to close at $4.12 per share on June 25, 2019.
The complaint alleges that, throughout the Class Period, the defendants made false and/or misleading statements and/or failed to disclose that: (i) Acer lacked sufficient data to support filing EDSIVO’s NDA with the FDA for the treatment of vEDS; (ii) 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; (iii) consequently, the FDA would likely reject EDSIVO’s NDA; and (iv) as a result, Acer’s public statements were materially false and misleading at all relevant times.
Investors who wish to discuss this securities fraud class action lawsuit and their legal options are encouraged to contact Kessler Topaz Meltzer & Check, LLP (James Maro, Jr., Esq. or Adrienne Bell, Esq.) at (844) 887-9500 (toll free) or at firstname.lastname@example.org.
Acer investors may, no later than August 30, 2019, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, or other counsel, or may choose to do nothing and remain an absent class member. A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. In order to be appointed as a lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.
Kessler Topaz Meltzer & Check prosecutes class actions in state and federal courts throughout the country involving securities fraud, breaches of fiduciary duties and other violations of state and federal law. Kessler Topaz Meltzer & Check is a driving force behind corporate governance reform, and has recovered billions of dollars on behalf of institutional and individual investors from the United States and around the world. The firm represents investors, consumers and whistleblowers (private citizens who report fraudulent practices against the government and share in the recovery of government dollars). The complaint in this action was not filed by Kessler Topaz Meltzer & Check. For more information about Kessler Topaz Meltzer & Check, please visit www.ktmc.com.