Ariad Pharmaceuticals Inc. (ARIA) plummeted 44 percent after U.S. regulators forced the company to temporarily suspend sales of its only drug, Iclusig for patients with certain forms of leukemia.
Ariad fell to $2.20 at the close of trading in New York, the lowest price since February 2010. The Cambridge, Massachusetts-based company stopped a study earlier this month aimed at expanding use of the drug after trials revealed an increased risk of blood clots.
A recent investigation found about 24 percent of patients using Iclusig in a mid-stage clinical trial experienced heart attacks, strokes and other serious vascular events, the Food and Drug Administration said in a statement today. It also found 67 percent of patients in clinical trials experienced high blood pressure and 8 percent had heart failure, including fatalities.
“At this time, FDA cannot identify a dose level or exposure duration that is safe,” the agency said.
Ariad had lost 89 percent of its market value this year before today. The company told analysts on a conference call today that it will discuss with the FDA changes to the label of Iclusig and potential risk mitigation strategies that may allow sales to resume. The drugmaker said it doesn’t know how long the suspension will take and plans to release financial results next week.
Iclusig was approved last year for two rare blood cancers based on an accelerated process that relied on a single trial showing it helped patients. Companies that gain accelerated approval must conduct additional study to prove the medicine is effective; Those further results for Iclusig showed the increased safety risks.
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