New Federal Securities Cases
A class action lawsuit has been filed in the United States District Court, Southern District of California, against ISIS Pharmaceuticals, Inc. ("Isis" or the "Company") (Nasdaq:ISIS) and certain of its officers, on behalf of a class consisting of all persons or entities who purchased or otherwise acquired securities of Isis between March 29, 2012 and October 15, 2012, both dates inclusive (the "Class Period"). This class action seeks to recover damages against the Company and certain of its officers and directors as a result of alleged violations of the federal securities laws pursuant to Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder.
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 lawsuit 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.
If you acquired Isis securities during the Class Period, you may, no later than February 26, 2013, request that the Court appoint you lead plaintiff of the class. Although your ability to share in any recovery is not affected by the decision whether or not to seek appointment as a lead plaintiff, lead plaintiffs make important decisions that could affect the overall recovery for class members, including decisions concerning settlement.
If you wish to discuss this action, or have any questions concerning this notice or your rights, please contact us.
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