Amgen reports earnings, submits Prolia response

Amgen Inc. (NASDAQ:AMGN) disclosed in its earnings announcement that it submitted a complete response to FDA for Prolia denosumab to treat postmenopausal osteoporosis. In October, FDA issued complete response letters for BLAs for Prolia to treat and prevent osteoporosis and to treat and prevent bone loss due to hormone ablation therapy in breast and prostate cancer patients.

Amgen reported 4Q09 adjusted diluted EPS of $1.05, missing by $0.08 the Street's estimate of $1.13 and down 1% from $1.06 in 4Q08. Revenues for the quarter were up 2% to $3.81 billion from $3.75 billion in 4Q08, but came in slightly below the Street's estimate of $3.85 billion. ...