Avanir Pharmaceuticals (AVNR)
Drug/indication: Zenvia for pseudobulbar effect
Approval decision date:: Oct. 30, 2010
Recent stock performance: At $3.04, stock is off its July high of $3.73.FDA rejected Zenvia in 2006. Avanir conducted a new phase III study using a lower dose of the drug and resubmitted to FDA for another review.
Cadence Pharmaceuticals (CADX) Drug/indication: Ofirmev for pain/fever Approval decision date: Nov. 4, 2010 Recent stock performance: At $8.21, stock is down 21% from its April high. This is the second review cycle for Ofirmev following an FDA complete response letter issued in February.
Amgen (AMGN) Drug/indication:Prolia for bone complications in cancer patients Approval decision date: Nov. 18, 2010 Recent stock performance: Amgen is down 8% for the year. Prolia was previously approved as a treatment for osteoporosis. Amgen is seeking additional approvals for Prolia in various cancer indications.
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