Lilly gets Priority Review for ramucirumab, reports 3Q13 earnings

Eli Lilly and Co. (NYSE:LLY) said FDA accepted and granted Priority Review to a BLA for ramucirumab ( IMC-1121B) as monotherapy for second-line gastric cancer. The pharma said it expects a decision from the agency in 2Q14 but did not disclose a specific PDUFA date. The human IgG1 mAb VEGFR-2 antagonist is also under review in Europe.

Separately, Lilly reported 3Q13 non-GAAP EPS of $1.11, beating by $0.07 the Street's $1.04 estimate and up from $0.79 in 3Q12. Revenues for the quarter were $5.8 billion, up 6% from $5.4 billion in 3Q12 and just above the Street's estimate of $5.76 billion. Lilly also raised the lower end of its 2013 non-GAAP EPS guidance to $4.10-$4.15 from $4.05-$4.15, but the pharma reiterated that it expects full-year revenues of $22.6-$23.4 billion. The Street was expecting 2013 EPS of $4.14 on $23 billion in revenues. ...