Intra-Cellular Therapies provides lumateperone regulatory update for the treatment of schizophrenia

Intra-Cellular Therapies, Inc. announced that the FDA has informed the Company that it does not have plans to schedule an Advisory Committee meeting in connection with its review of the Company’s New Drug Application (NDA) for lumateperone for the treatment of schizophrenia. The lumateperone Prescription Drug User Fee Act (PDUFA) goal date is December 27, 2019.

Additionally, the Company recently submitted to the FDA the results of non-clinical analyses the Company previously announced it had agreed to conduct related to toxicology findings in animal studies. The Company believes the results of these analyses provide additional support for its position that the metabolic pathway, and the metabolites formed, are different in animals and humans and therefore toxicity findings in animals are not relevant to humans.