EpiCept shares hammered after FDA rejects app, demands new trial

Shares of EpiCept (EPCT) cratered this morning after the developer announced that the FDA had handed back its NDA on a new therapy for AML, saying that it needed to mount a new pivotal trial in order to make its case for Ceplene. Approved in Europe two years ago, the therapy is co-administered with IL-2. But the company reported that regulators concluded that "the application did not establish Ceplene's therapeutic contribution in its combination with IL-2, and recommended that an additional...