Ariad falls on ponatinib boxed warning

Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) fell $4.95 (21%) to $18.93 on Friday after FDA said it included a boxed warning on the label for the company's newly approved leukemia drug Iclusig ponatinib. FDA granted accelerated approval to Iclusig to treat chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) that is resistant to or intolerant of prior treatment with tyrosine kinase inhibitors (TKIs). The approval comes more than three months ahead of Iclusig's March 27 PDUFA date.

The drug's label includes a black box warning about the risk of arterial thrombosis and liver toxicity observed with use of Iclusig. On a conference call, the company said it does not believe the warning will affect the drug's uptake. Ariad plans to launch the drug in the U.S. in about two weeks with a wholesale acquisition cost (WAC) of $9,580 for a month's supply, or about $115,000 per year. ...