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May 17, 2010
 |  BioCentury  |  Finance

Regulatory Milestones

Highlights of weekly biotech stock moves

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.

Cipher Pharmaceuticals Inc. (TSX:DND) gained C$0.53 (48%) to C$1.63 last Monday after FDA approved Cip-tramadol ER to treat moderate to moderately severe chronic pain. Cipher, which is seeking a marketing partner, said the drug's launch is dependent on the outcome of a pending appeal in a suit involving controlled-release tramadol patents (see B10).

For the week, Cipher was up C$0.05 to C$1.15.

Isotechnika Pharma Inc. (TSX:ISA) gained...

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