ALK-Abello A/S (CSE:ALK-B) gained DKK8.50 to DKK482 last week after reporting that FDA's Allergenic Products Advisory Committee will meet on Nov. 6 to discuss a BLA from partner Merck & Co. Inc. (NYSE:MRK) for grass Allergy Immunotherapy Tablet (AIT). Merck, which has North American rights, expects a decision in 1Q14. ALK-Abello markets grass AIT as Grazax in Europe.
Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) gained $3.71 (20%) to $22.31 last week after saying it has enrolled about 264 of a planned 500 patients in the Phase III EPIC trial of Iclusig ponatinib to treat newly diagnosed chronic myelogenous leukemia (CML). Ariad plans to complete enrollment by year end and conduct an interim efficacy analysis in 3Q14.
FDA granted accelerated approval to Iclusig in December to treat CML and Philadelphia-chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) that is resistant or intolerant to prior treatment with tyrosine kinase inhibitors (TKIs). The EC approved the drug for the same indications in