Highlights of weekly biotech stock moves
Regulatory, clinical and other 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).
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.
Bavarian Nordic A/S (CSE:BAVA) added DKK3.50 to DKK63.50 last week after the European Commission approved an MAA for the company's Imvanex smallpox vaccine. The vaccine is in Phase III testing in the U.S.
Celgene Corp. (NASDAQ:CELG) gained $0.07 to $142.07 on Friday after the European Commission approved Imnovid pomalidomide to treat patients with relapsed and refractory multiple myeloma (MM). FDA granted accelerated approval to the product as Pomalyst in February