NEW YORK, Jan. 3, 2013 /PRNewswire/ -- Bernstein Liebhard LLP today announced that a class action has been commenced in the United States District Court for the Southern District of California on behalf of a class (the "Class") of purchasers of Isis Pharmaceuticals, Inc. ("Isis" or the "Company") (NASDAQ: ISIS) securities between March 29, 2012 and October 15, 2012 inclusive (the "Class Period").
Isis is the leading company in antisense drug discovery and development. The Company's strategy is to discover unique antisense drugs and develop these drugs to key clinical value inflection points.
The Complaint alleges that throughout the Class Period, the Company conditioned investors to believe that Kynamro (mipomersen sodium), one of the drugs in its pipeline, would receive approval from the U.S. Food and Drug Administration ("FDA") through a host of materially false and misleading statements regarding the safety and efficacy of the drug, as well as reportedly positive results from Kynamro's phase three clinical trial. As a result of the foregoing, the Company's statements were materially false and misleading at all relevant times.On October 16, 2012, two days prior to a meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee to decide on whether to recommend Kynamro for FDA approval, the FDA published a clinical briefing document questioning the safety and efficacy of Kynamro. Specifically, the report noted that abnormal growths or neoplasms developed in 3.1% of patients treated with Kynamro, as compared to only 0.9% of patients who took a placebo. The FDA report concluded that this "imbalance in neoplasms will need to be assessed further in on-going and future studies and post-marketing (if approved)." In addition, the report found that three patients treated with Kynamro died during clinical testing. Two died of heart attacks and the other patient died of acute liver failure, and the report concluded that "the potential for a contributing effect of mipomersen cannot be ruled out." As a result of this disclosure, Isis shares declined $2.88 per share or nearly 22%, to close at $10.27 per share on October 16, 2012. Plaintiffs seek to recover damages on behalf of all Class members who invested in Isis securities during the Class Period. If you invested in Isis securities as described above during the Class Period, and either lost money on the transaction or still hold the shares, you may wish to join in this action to serve as lead plaintiff. In order to do so, you must meet certain requirements set forth in the applicable law and file appropriate papers no later than February 26, 2013. 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. Under certain circumstances, one or more class members may together serve as lead plaintiff. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. You may retain Bernstein Liebhard LLP, or other counsel of your choice, to serve as your counsel in this action.
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