June 16, 2020 - The court granted in part and denying in part the defendants' motion to dismiss.
May 1, 2020 - A motion to dismiss the second amended complaint was filed.
February 28, 2020 - A second amended complaint was filed.
December 3, 2019 - An amended complaint was filed.
July 1, 2019 - An investor in shares of Acer Therapeutics Inc. (NASDAQ: ACER) filed a lawsuit in the U.S. District Court for the Southern District of New York over alleged violations of Federal Securities Laws by Acer Therapeutics Inc. in connection with certain allegedly false and misleading statements made between September 25, 2017 and June 24, 2019.
Newtown, MA based Acer Therapeutics Inc., a pharmaceutical company, focuses on the acquisition, development, and commercialization of therapies for serious rare and life-threatening diseases. Acer Therapeutics Inc’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 Therapeutics Inc, “[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-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.” 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—announced that it had obtained exclusive rights to NDA-enabling clinical data from AP-HP for the use of celiprolol in treating vEDS. Specifically, Private Acer 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.
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 Therapeutics Inc began trading on the NASDAQ under the ticker symbol “ACER.”
On December 26, 2018, Acer Therapeutics Inc 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.
On June 25, 2019, Acer Therapeutics Inc 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.
Shares of Acer Therapeutics Inc. (NASDAQ: ACER) declined to as low as $3.27 per share on June 28, 2019.
According to the complaint the plaintiff alleges on behalf of purchasers of Acer Therapeutics Inc. (NASDAQ: ACER) common shares between September 25, 2017 and June 24, 2019, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between September 25, 2017 and June 24, 2019, the Defendants made false and/or misleading statements and/or failed to disclose that Acer lacked sufficient data to support filing EDSIVO’s NDA with the FDA for the treatment of vEDS, that 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, that consequently, the FDA would likely reject EDSIVO’s NDA, and that as a result, the Company’s public statements were materially false and misleading at all relevant times.