NEW YORK, July 08, 2019 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Acer Therapeutics, Inc. (“Acer” or the “Company”) (NASDAQ: ACER) and certain of its officers. The class action, filed in United States District Court, for or the Southern District of New York, and indexed under 19-cv-06137, is on behalf of a class consisting of all persons and entities other than Defendants who purchased or otherwise acquired Acer securities between September 25, 2017 and June 24, 2019, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.
If you are a shareholder who purchased Acer securities during the class period, you have until August 30, 2019, to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at firstname.lastname@example.org or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 9980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
Acer was founded in 2013 and is headquartered in Newton, Massachusetts. Acer is a pharmaceutical company that purportedly 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, abnormal connections between blood vessels known as arteriovenous fistulas, arterial dissections, and spontaneous vascular ruptures, all of which are potentially life-threatening. According to Acer, “[t]he median survival age of vEDS patients in the United States is 51 years, with arterial rupture being the most common cause of sudden death.”
In 2004, the French research hospital, Assistance Publique—Hôpitaux de Paris, Hôpital Européen Georges Pompidou (“AP-Hewlett Packard”), published data on vEDS patients. Based on AP-Hewlett Packard’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.” The Ong trial’s results were published on October 30, 2010.
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 obtained exclusive rights to NDA-enabling clinical data from AP-Hewlett Packard for the use of celiprolol in treating vEDS. Specifically, Private Acer had signed an agreement with AP-Hewlett Packard, 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.
On September 19, 2017, Private Acer announced that it had closed a merger with Opexa Therapeutics, Inc. (“Opexa”), a publicly-traded Texas pharmaceutical corporation, whereby Private Acer survived as a wholly-owned subsidiary of Opexa (the “Opexa Merger”). Following the Opexa Merger, Opexa changed its name to Acer Therapeutics Inc and Private Acer’s management took control of the combined company. Immediately prior to the Opexa Merger, Opexa’s Board of Directors and Neil K. Warma (“Warma”), Opexa’s then-President, Chief Executive Officer (“CEO”), Acting Chief Financial Officer, and Secretary, resigned.
On September 21, 2017, Acer began trading on the NASDAQ under the ticker symbol “ACER.”
On December 26, 2018, Acer announced that the U.S. Food and Drug Administration (“FDA”) had accepted the Company’s NDA for EDSIVO for the treatment of vEDS in patients with a confirmed type III collagen mutation, as well as the FDA’s grant of priority review of the NDA and an assigned Prescription Drug User Fee Act (“PDUFA”) target action date of June 25, 2019.
The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational and compliance policies. Specifically, 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, the Company’s public statements were materially false and misleading at all relevant times.
On June 25, 2019, Acer issued a press release titled “Acer Therapeutics Receives Complete Response Letter from U.S. FDA for use of EDSIVO™ (celiprolol) in vEDS Patients” (the “June 2019 Press Release”). In the June 2019 Press Release, Acer disclosed receipt of a Complete Response Letter (“CRL”) from the FDA regarding its NDA for EDSIVO for the treatment of vEDS. Acer advised investors that “[t]he CRL states that it will be necessary to conduct an adequate and well-controlled trial to determine whether celiprolol reduces the risk of clinical events in patients with vEDS” and that “Acer plans to request a meeting to discuss the FDA’s response.”
That same day, news sources reported that the small group size of the Ong Trial had raised questions among experts about the adequacy of EDSIVO’s 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 Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.
Robert S. Willoughby