Acer investors may receive additional information about the case by clicking the link "Submit Your Information" above.
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.
If you are a member of the class described above, you may no later than August 30, 2019 move the Court to serve as lead plaintiff of the class, if you so choose.
A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed 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, however, affected by the decision whether or not to serve as a lead plaintiff. Returning the attached form or communicating with any counsel is not necessary to participate or share in any recovery achieved in this case. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.
Kessler Topaz Meltzer & Check, LLP has not filed a complaint in this matter. If you wish to discuss this action or have any questions concerning this notice or your rights or interests with respect to these matters, please contact Kessler Topaz Meltzer & Check, LLP toll free at 1-844-887-9500 or 1-610-667-7706, or via e-mail at info@ktmc.com. If you would like additional information about the suit, please click on the link "Submit Your Information" above and fill out the form as promptly as possible.
CONTACT:
Kessler Topaz Meltzer & Check, LLP
James Maro, Esq. or Adrienne Bell, Esq.
280 King of Prussia Road
Radnor, PA 19087
1-844-887-9500 (toll free) or 1-610-667-7706
Or by e-mail at info@ktmc.com