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Isis Sued over Stock Drop following Kynamro Safety Report by FDA

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Isis Pharmaceuticals and its top executives have been sued as part of class action litigation over allegedly misleading claims made about the company's investigational cholesterol drug Kynamro and the subsequent drop in the firm's stock price following a troubling regulatory review of the agent.

According to the lawsuit, which was filed on behalf of Isis investors, Isis and its management made “materially false and misleading statements regarding the safety and efficacy of the product, as well as reportedly positive results from Kynamro’s clinical trials.”

However, in October, the US Food and Drug Administration published a clinical briefing document noting the incidence of abnormal growths or neoplasms in some patients treated with the drug, which has been submitted as a treatment for homozygous familial hypercholesterolemia. The report also found that three patients treated with Kynamro had died during clinical testing.

As a result, shares of Isis dropped nearly 22 percent to $10.27 on Oct. 16. This week, the stock was trading around $10.75.

Even though an FDA advisory committee later recommended the drug for approval by a split vote, the lawsuit states that Isis investors suffered “significant damages” due to the company's failure to disclose Kynamro's safety issues.

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