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Stock Falls on Black-Box Warning

FDA Surprises Ariad with Early Nod for Ponatinib in CML, ALL

By Jennifer Boggs
Managing Editor

Saturday, December 15, 2012

Ariad Pharmaceuticals Inc. got an unexpected holiday gift from the FDA, with the agency granting approval to its much-lauded pan BCR-ABL inhibitor, ponatinib, more than three months ahead of the drug's March 27, 2013, PDUFA date, and only two months after the Cambridge, Mass.-based firm completed a rolling new drug submission.

Ponatinib, which has been branded Iclusig, already had been slated for a priority six-month review based and accelerated approval had been widely expected by analysts.

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