BioCentury
ARTICLE | Finance

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones

August 12, 2013 7:00 AM UTC

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).

Ariad also reported 2Q13 earnings, including $13.9 million in quarterly net sales of Iclusig ponatinib. FDA granted accelerated approval to Iclusig in December to treat chronic myelogenous leukemia (CML) and Philadelphia-chromosome positive (Ph+) acute lymphoblastic leukemia (ALL); in July, the EC approved the drug for the same indications...