Boston, MA 10/11/2013 (wallstreetpr) – Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) has suffered a huge setback after the FDA put a partial hold on enrollments in the trial of the company’s cancer drug Inclusig, sending stock prices tumbling in unprecedented fashion. Shares dropped 66% to $5.83 which would represent the biggest drop in price since Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) started trading publicly in 1994.
The Food and Drug Administrative, which has regulatory control over pharmaceuticals in the United States, found that serious arterial thrombosis occurred in almost 12 percent of patients treated with Inclusig while another 6% experienced cardiovascular events. This was serious enough to warrant further study but in a statement released on Wednesday, Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) said that they are still allowed to continue giving the drug to people already in the trial but dosage in some cases will have to be reduced.
Inclusig obtained accelerated approval last year for treatment of two rare forms of leukemia but because the approval process was based on a single study which showed positive results, Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) is still required to conduct additional testing to prove conclusively that the drug is effective.
The FDA confirmed that the hold was indeed placed on the drug trial as further investigation was done to evaluate all safety options and scenarios since the design of the initial study made it difficult to determine whether the cardiovascular complications were being caused by Inclusig. Depending on the outcome of the FDA review there is a chance that the regulatory body may call for it to be removed from the market. The nature of the pharmaceuticals industry means that it is unlikely for the stock to recover anytime soon since drug safety and approval is the biggest catalyst for success.
Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) is working closely with the FDA to ensure that patient safety is protected at all times and they have made it clear that they are willing to make any changes to dosage, drug design or even labeling will be made so that trials can resume and Inclusig will remain on the market.
