Regulatory milestones

Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) was down $1.43 to $18.43 last week after disclosing that FDA denied breakthrough therapy designation for AP26113 for anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Ariad said FDA did not grant the designation to the small molecule dual inhibitor of ALK and EGFR because of the "relatively short follow-up" and the small number of ALK-positive patients in the Phase I portion of a Phase I/II trial (see B10).