Ariad storms back with an FDA nod to get Iclusig back on the U.S. market

Ariad Pharmaceuticals CEO Harvey Berger

Losing more than $2.5 billion in market value didn't kill Ariad Pharmaceuticals ($ARIA), and now the biotech is set to relaunch the once-spurned cancer drug Iclusig in the U.S. as the FDA has approved a new label and indication for the company's only product.

Ariad surged more than 30% on the news, announcing it would reintroduce the leukemia treatment by mid-January now that the FDA has OK'd the drug for T315I-positive patients and amended the label to include warnings about Iclusig's risk of blood clotting and heart failure. Those same safety concerns prompted the FDA to ask Ariad to take its drug off the market in October, the heaviest blow in a downward spiral that blasted the company's shares by more than 70%. But that's all in the past, CEO Harvey Berger said.

"We are back on track," Berger told Bloomberg. "We'll enter 2014 largely where we were as we started off the fall in September."

"Largely" being a relative term, of course. Ariad's hellish October led it to lay off about 160 U.S. employees in an effort to save $26 million, and while the company plans to piece together another U.S. sales force, it won't have the same marketing heft as before, Berger said. Furthermore, while the European Medicines Agency hasn't ordered Iclusig off the market, the group's Pharmacovigilance Risk Assessment Committee has reopened the books on the drug's safety profile, putting Ariad's overseas sales in jeopardy.

Still, Iclusig's exit from the tomb is undoubtedly good news for Ariad, as many analysts speculated it might take a year to win over the FDA if it ever happened at all. The company's shares leapt as high as $7.74 on the Friday announcement, by far their highest mark since an October freefall.

"In less than two months of suspending marketing and commercial distribution of Iclusig in the U.S., we addressed the issues raised by the FDA and now are able to market and distribute Iclusig again in the U.S.," Berger said in a statement.

- read the announcement
- check out the Bloomberg story

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