LOS ANGELES--(BUSINESS WIRE)--Glancy Binkow & Goldberg LLP, representing investors of ISIS Pharmaceuticals, Inc. (“ISIS” or the “Company”) (NASDAQ:ISIS), announces that a class action lawsuit has been filed in the United States District Court for the Southern District of California on behalf of a class (the “Class”) comprising all purchasers of ISIS securities between March 29, 2012 and October 15, 2012, inclusive (the “Class Period”).
“imbalance in neoplasms will need to be assessed further in on-going and future studies and post-marketing (if approved)”
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.
If you are a member of the Class described above, you may move the Court, no later than February 26, 2013 to serve as lead plaintiff; however, you must meet certain legal requirements. If you wish to learn more about this action or have any questions concerning this Notice or your rights or interests with respect to these matters, please contact Michael Goldberg, Esquire, of Glancy Binkow & Goldberg LLP, 1925 Century Park East, Suite 2100, Los Angeles, California 90067, by telephone at (310) 201-9150 or Toll Free at (888) 773-9224, by e-mail to firstname.lastname@example.org, or visit our website at http://www.glancylaw.com.
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