Glancy Binkow & Goldberg LLP announces that all purchasers of the common stock of ISIS Pharmaceuticals, Inc. (“ISIS” or the “Company”) (NASDAQ:ISIS) between March 29, 2012 and October 15, 2012, inclusive (the “Class Period”), have until February 26, 2013 to file a motion with the Court to be appointed as lead plaintiff. The securities fraud class action lawsuit was filed in the United States District Court for the Southern District of California.
ISIS engages in the discovery and development of drugs utilizing antisense technology to primarily treat cardiovascular, metabolic, severe and rare diseases, as well as cancer. The Complaint alleges that throughout the Class Period the Company and certain of its executive officers issued materially false and misleading statements regarding the safety and efficacy of the Company’s flagship product, Kynamro (mipomersen sodium), for the treatment of patients with Homozygous Familial Hypercholesterolaemia. Specifically, the Complaint alleges that defendants, through a series of materially false and misleading statements regarding the safety and efficacy of the product, and reportedly positive results from Kynamro’s clinical trials, conditioned investors to believe that Kynamro would receive approval from the U.S. Food and Drug Administration (FDA).
On October 16, 2012 the FDA published a clinical briefing document raising concerns regarding the safety and efficacy of Kynamro, noting among other things, 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; that the data submitted by the Company was limited by a small sample size and a short treatment time, and that during the clinical testing two patients treated with Kynamro died of heart attacks and another patient died of acute liver failure. 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),” and that “the potential for a contributing effect of mipomersen cannot be ruled out” in the patient deaths. As a result of these disclosures, ISIS shares declined nearly 22%, to close at $10.27 on October 16, 2012.