Intra-Cellular Therapies (ITCI) announced that it has submitted a supplemental new drug application (sNDA) to the FDA aiming to expand the approved uses of its lead drug, Caplyta (lumateperone), to include treating major depressive disorder (MDD) in adults as an adjunctive therapy to antidepressants.The sNDA submission is supported by positive results from two late-stage studies, Studies 501 and 502, that evaluated 42 mg of lumateperone as an adjunctive therapy to antidepressants for MDD. Both studies met t ...