FDA cancels Advisory Committee meeting for lumateperone for the treatment of schizophrenia

Intra-Cellular Therapies, Inc. announced that the FDA has cancelled the Psychopharmacologic Drugs Advisory Committee meeting scheduled for 31 July 2019 to discuss the New Drug Application (NDA) for lumateperone for the treatment of schizophrenia. The Company recently provided additional information to the FDA in response to information requests relating to non-clinical studies. The FDA cancelled the Advisory Committee meeting to allow sufficient time to review this new and any forthcoming information as they continue the NDA review.

This information may result in an extension of the 27 September 2019 Prescription Drug User Fee Act (PDUFA) target action date for the lumateperone NDA.