Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA)’s Iclusig Makes A Comeback
Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA)’s cheered the most happening week as the stock gained more than 60% during past week, including 16.5% gains reported on Friday. The stock traded with a staggering volume of 150.02 million shares, more than 5 times compared to its 30 day average volume of 28.41 million shares.
The Booster Dose
While the European Medicines Agency boosted the stock of Ariad Pharmaceuticals during mid of the week, it was the U.S. Food and Drug Administration to power the rally in this stock on Friday. Earlier, the EMA posted on its website to review Ariad’s Iclusig at its December meeting. Now the USFDA has allowed immediate resumption of marketing and commercial distribution for Ariad’s Iclusig, a drug to treat certain types of Leukemia.
Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) announced on Friday that the USFDA has approved revised USPI (U.S. Prescribing Information) as well as REMS (Risk Evaluation and Mitigation Strategy) for Iclusig. Approval of USPI was based on the USFDA’s review of the Iclusig clinical-trial data, including pivotal PACE trial that studied 24-month follow up.
The boxed warning has also been revised to alert the healthcare providers and patients to the risk of vascular occlusive events. Moreover it also includes a new warning for heart failure.
The Elite Speak
Chairman and Chief Executive Officer of Ariad Pharmaceuticals, Harvey Berger said, “As we look ahead to re-launching Iclusig in the U.S. and fulfilling our post-marketing requirements, we will continue to focus on understanding the benefits and risks of Iclusig treatment in patients with resistant or intolerant Philadelphia-positive leukemias.”
The CEO also emphasized that company addressed the issues raised against Iclusig in less than two months and now once again it will be able to market and distribute its leading oncology candidate. Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA) will resume commercial distribution of Iclusig by mid-January.
An analyst with Stifel Financial Corp. (NYSE:SF), Joel Sendek increased his sales estimates by $5 million to $125 million and also upgraded his price target for the stock to $10.