Regulatory Milestones

Amgen Inc. (NASDAQ:AMGN) could move on Monday this week after the company announced late last Friday that it had submitted a BLA to FDA for denosumab to reduce skeletal related events (SREs) in cancer patients. Denosumab is already under review to treat postmenopausal osteoporosis, with a July 25 PDUFA. Amgen was up $0.23 to $54.69 last week.

Cadence Pharmaceuticals Inc. (NASDAQ:CADX) could move on Monday this week after the company announced late last Friday that FDA accepted an NDA resubmission for Ofirmev IV acetaminophen to treat pain and fever. The agency designated the resubmission as a Class 2 response and assigned a Nov. 4 PDUFA date. Cadence was up $0.29 to $9.09 last week...