Intra-Cellular Therapies(US:ITCI)2021-10-07 17:25CAPLYTA (Lumateperone) - CAPLYTA is FDA-approved for the treatment of schizophrenia in adults[6] - The company is seeking approval for lumateperone for bipolar depression, with sNDAs under review by the FDA and a PDUFA action date of December 17, 2021[6, 36] - The company is expanding lumateperone development with late-stage programs in additional depressive disorders, including adjunctive treatment of Major Depressive Disorder (MDD) and Bipolar depression and MDD with mixed features[6] - In a 1-year open-label trial, schizophrenia symptoms remained stable and the mean change in body weight was approximately -3.2 kg (~7 lbs) at Day 350[30] Market and Prevalence - Approximately 24 million adults in the U S live with schizophrenia[26, 28] - Approximately 11 million adults in the U S live with bipolar disorder, representing 4 4% lifetime prevalence[26, 34] - Approximately 17 3 million adults in the U S have at least one depressive episode[26, 45] - About 1/3 of patients with MDD and bipolar depression exhibit mixed features[26, 49] - Approximately 74% of patients discontinue schizophrenia treatment within 18 months of initiation[28] Pipeline and Financials - The company had $556 2 million in total cash, cash equivalents, and investments as of June 30, 2021[63] - The company had $0 0 million in total debt as of June 30, 2021[63]