According to the law firm press release, Hemispherx Biopharma, Inc. ("Hemispherx") is a biopharmaceutical company that focuses on the development of nucleic acids to enhance the natural anti-viral defense systems of the human body. The Company’s lead product, Ampligen®, is undergoing clinical trials for the treatment of Myalgic Encephalomylitis/Chronic Fatigue Syndrome.
The Complaint alleges that throughout the Class Period, the Company made a host of materially false and misleading statements regarding the safety and efficacy of Ampligen, and touted purportedly positive results from Ampligen’s clinical trials. As a result of the foregoing, the Company’s statements were materially false and misleading at all relevant times.
On December 18, 2012, the FDA published an FDA staff report concerning Ampligen’s safety and efficacy. Specifically, the report concluded that the Company’s studies were “ill-defined and invalid” with signals of efficacy that were inconsistent between clinical trials, and based on the limited quality of the data, “it is difficult to draw conclusions regarding potential safety signals,” but the “review identified nine potential safety concerns associated with Ampligen.”
As a result of this disclosure, Hemispherx shares declined $0.276 per share or nearly 43%, to close at $0.368 per share on December 18, 2012.
On March 13, 2013, the Court appointed lead Plaintiffs in this action and also lead Counsel. Lead Plaintiffs filed their consolidated amended Complaint on May 20.
On January 23, 2014, the Defendants’ motion to dismiss was DENIED.
On February 25, 2015, the Parties entered into a Stipulation of Settlement. The Settlement was preliminarily approved by the Court on April 8. On July 22, the Court granted final approval of the Settlement and dismissed this case. Also on July 22, the Court approved attorneys' fees and expenses.