Jun 17 2011
Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced that NASDAQ has halted trading of the company's common stock. The Dermatologic and Ophthalmic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is meeting to discuss the company's Biologics License Application (BLA) for EYLEA™, also known as VEGF Trap-Eye, for the treatment of the neovascular form of age-related macular degeneration (wet AMD).
Regeneron submitted a BLA for marketing approval in wet AMD in the U.S. in February 2011 and received a Priority Review designation. Under Priority Review, the target date for an FDA decision on the EYLEA BLA is August 20, 2011.