Ariad Pharmaceuticals (ARIA) Spikes as FDA Approves Iclusig Again

And the ongoing saga of Ariad Pharmaceuticals ($ARIA) rolls on. The company spiked on Friday after getting its own little Christmas present from the FDA in the form of permission to resume marketing and distributing leukemia treatment iclusig. Shares have spiked almost 25 percent as a result.

Iclusig’s Return Spurs Rally

The drug was pulled earlier this year over concerns about it causing blood clotting, prompting it to lose just over 65 percent and almost 85 percent through the end of October. Since the start of November, though, shares have been in a volatile rally that’s moved in fits and starts but still resulted in shares more than tripling after today’s rally was included.

It’s the second piece of good news for Ariad this week, as shares bounced on Tuesday following news that the European Medicines Agency would be reviewing Iclusig.

ARIA Back in the Game, but With Limits

Ariad’s fate is clearly closely tied to iclusig, the company’s lone entrant into the pharmaceutical market. As such, today’s news was of crucial importance, and prompted the announcement that it was bringing on a small sales force, including some of the 160 people who were laid off this fall after the initial news that iclusig was getting pulled. The company anticipates the new staff will be paid for by the increased revenue they will create.

“We are back on track,” CEO Harvey Berger told Bloomberg in a telephone interview. “We’ll enter 2014 largely where we were as we started off the fall in September.”

However, iclusig’s return comes with certain limitations. Contingent on the FDA approving the drug’s return are a number of new prescribing restrictions and warnings regarding the issue of blood clotting.

“It’s really leaving the decision-making to the physician to determine whether other therapies are indicated,” Berger said. “It doesn’t require that a patient has failed each and every other therapy; it really leaves that decision to the doctor.”

Ariad does have one other drug in its pipeline in the form of AP26113, a small molecule that “exhibited activity as a potent tyrosine-kinase inhibitor of anaplastic lymphoma kinase (ALK) and epidermal growth factor receptor (EGFR) and c-ros oncogene 1 (ROS1)” according to the company’s website. It’s currently in phase II trials.