Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
ALK-Abello A/S (CSE:ALK-B) added DKK24 to DKK616 on Christmas week after FDA said its Allergenic Products Advisory Committee will meet on Jan. 28 to discuss a BLA for Ragwitek ragweed Allergy Immunotherapy Tablet (AIT) to treat ragweed pollen-induced allergic rhinitis, with or without conjunctivitis.
The pharma submitted the BLA in March and said it expects a decision in 1H14. Merck & Co. Inc. (NYSE:MRK) has exclusive North American rights.
Cell Therapeutics Inc. (NASDAQ:CTIC; Milan:CTIC) gained $0.33 (18%) to $2.20 last week after FDA lifted a partial clinical hold on tosedostat (CHR2797). The agency placed the hold in June and requested additional data after a tosedostat-treated patient died of myocarditis. Tosedostat is in Phase II testing for acute myelogenous leukemia (AML) and myelodysplastic syndromes (MDS).
Earlier in the week, the U.K.'s NICE issued a final appraisal determination (FAD) recommending Pixuvri pixantrone in patients with relapsed or refractory non-Hodgkin's B cell lymphoma who have previously been