ISIS Pharmaceuticals (ISIS) Securities Class Action Lawsuit
ISIS Pharmaceuticals (ISIS) securities class action summary
During September 2012, ISIS Pharmaceuticals (ISIS) stock price closed as high as $15.61. On October 15, 2012, ISIS Pharmaceuticals traded below $9 per share. This means that in less than six weeks ISIS Pharmaceuticals lost over $500 million in market value. Why? On October 16, 2012, the FDA published a clinical briefing stating that patients in a clinical trial of one of ISIS drugs experienced abnormal neoplasms at a statistically significant rate bringing into question at least the timing of when ISIS could bring the new drug to market and the warning to patients that ISIS may need to include. This news may well account for the sudden and precipitous drop experienced by ISIS shareholders.
ISIS Pharmaceuticals discovers and develops antisense drug
Isis Pharmaceuticals engages in the discovery and development of antisense drugs using its antisense drug discovery platform. An antisense drug seeks to treat a disease where the underlying genetic disorder of that disease is known to researchers. An “antisense” is a synthesized nucleic acid (DNA, RNA or a chemical equivalent) that can bind directly to the messenger RNA from the disease-causing gene thereby rendering it inactive. ISIS “flagship” antisense therapy is called Kynamro. It is an apo-B synthesis inhibitor in development for the reduction of low-density lipoprotein cholesterol.
Did ISIS Pharmaceuticals mislead investors about the safety and efficacy of Kynamro?
On October 18, 2012, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee was set to decide on whether to recommend Kynamro for FDA approval. Two days prior to that meeting, 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 [Kynamro] 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.
ISIS Pharmaceuticals Securities Fraud Investigation
Our investigation focuses on when senior management became aware of the underlying facts that made up the FDA report and the timing of the disclosures to ISIS shareholders. Specifically, did ISIS Pharmaceuticals mislead investors that Kynamro would receive approval from the FDA through a series of materially false and misleading statements regarding the safety and efficacy of Kynamro., as well as reportedly positive results from Kynamro's phase three clinical trial. These questions are at the heart of our investigation of the ISIS Pharmaceuticals (ISIS) securities class action. If you bought ISIS securities and would like to learn more about possible claims, please contact us via the contact form or call George Pressly Esq. at 1-800-631-6234.
ISIS Shareholder Submission Form