ARTICLE | Top Story

FDA extends Eylea review

August 17, 2011 12:09 AM UTC

FDA extended the PDUFA date for ophthalmic candidate Eylea aflibercept from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) by three months to Nov. 18 from Aug. 20. FDA needs time to review additional CMC information submitted at the agency's request, according to Regeneron. Eylea is under review to treat wet age-related macular degeneration (AMD). Regeneron, which made the announcement after market close, was off $0.75 to $57.42 on Tuesday. In early after-hours trading, the stock was off $7.42 (13%) to $50. ...