Cempra investors may receive additional information about the case by clicking the link "Join this Class Action" above.
According to the complaint, Cempra is a clinical-stage pharmaceutical company, focusing on developing antibiotics to meet medical needs in the treatment of bacterial infectious diseases in North America. One of its lead product candidates is solithromycin (CEM-101), which is in Phase III clinical trials for the treatment of community acquired bacterial pneumonia, as well as for uncomplicated bacterial urethritis.
The Class Period commences on May 1, 2016, when Cempra issued a press release announcing the completion of its rolling submission of the company’s New Drug Application (“NDA”) for solithromycin to the FDA.
According to the complaint, on November 2, 2016, the FDA posted on its website a preliminary review of solithromycin. The FDA reported that “[a] significant safety signal for hepatotoxicity was observed in the solithromycin development program,” and there was concern for “the high rate of infusion site-related reactions.”
Following this news, Cempra stock fell $11.35, or 60.86%, to close at $7.30 on November 2, 2016.
On November 4, 2016, Cempra issued a press release announcing that NASDAQ has halted trading of the company’s common stock. Cempra also announced that the FDA’s Antimicrobial Drugs Advisory Committee (“AMDAC”) would meet that day to discuss the safety and efficacy of solithromycin to treat community-acquired bacterial pneumonia.
The complaint alleges that throughout the Class Period, the defendants made materially false and misleading statements regarding the company’s business, operational and compliance policies. Specifically, the complaint alleges that the defendants made false and/or misleading statements and/or failed to disclose that: (i) Cempra’s lead product candidate solithromycin posed significant safety risks for hepatotoxicity; and (ii) as a result of the foregoing, Cempra’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 January 3, 2017 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. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of their 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 1-888-299-7706 or 1-610-667-7706, or via e-mail at firstname.lastname@example.org.
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