Regulatory Milestones

Alkermes Inc. (NASDAQ:ALKS) was up $0.89 to $14.87 last week after FDA's Psychopharmacologic Drugs Advisory Committee voted 12-1 to recommend approval of an sNDA to extend the label of Vivitrol naltrexone to prevent relapse to opioid use in opioid-dependent patients. The PDUFA date is Oct. 12; the application is under Priority Review. Vivitrol is marketed in the U.S. to treat alcohol dependence (see "Comparative Addiction," A13).

Amgen Inc. (NASDAQ:AMGN) gained $0.87 to $55.22 last week after the U.K.'s NICE issued a final appraisal determination (FAD) recommending the use of Prolia denosumab for the primary and secondary prevention of osteoporotic fragility fractures only in postmenopausal women at increased risk of fractures when oral bisphosphonates are unsuitable. The human mAb targets receptor activator of NF-kappa B ligand (RANKL; TNFSF11) (see Online Links, A21). ...