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PRTC: Karuna's NDA for KarXT Accepted by U.S. FDA
PRTC: Karuna's NDA for KarXT Accepted by U.S. FDA.
About this update from Puretech Health Plc
[{"type":"text","content":"\n\n \nPureTech Founded Entity Karuna Therapeutics Announces U.S. Food and Drug Administration Accepts New Drug Application for KarXT for the Treatment of Schizophrenia\nPrescription Drug User Fee Act (PDUFA) action date is September 26, 2024\nIf approved, KarXT would represent the first new pharmacological approach to treating schizophrenia in several decades\nThe application is supported by positive data from the EMERGENT clinical trial program showing KarXT is associated with significant improvements in schizophrenia symptoms\nBOSTON - November 29, 2023 - PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (\"PureTech\" or the \"Company\"), a clinical-stage biotherapeutics company, noted today that its Founded Entity, Karuna Therapeutics, Inc. (Nasdaq: KRTX) (\"Karuna\") announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for KarXT (xanomeline-trospium) for the treatment of schizophrenia in adults. The application has been granted a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024.\nThe NDA submission is supported by efficacy and long-term safety data from the EMERGENT program, the clinical program evaluating KarXT as a treatment for schizophrenia. The EMERGENT program includes the three completed positive EMERGENT-1, EMERGENT-2, and EMERGENT-3 trials evaluating the efficacy and safety of KarXT compared to placebo, and the EMERGENT-4 and EMERGENT-5 trials evaluating the long-term safety of KarXT.\nPureTech is a founder of Karuna and co-inventor of the KarXT program. If approved, KarXT will be the third therapeutic candidate to be taken from inception at PureTech to FDA regulatory approval.\nThe full text of the announcement from Karuna is as follows:\n \nKaruna Therapeutics Announces U.S. Food and Drug Administration Accepts New Drug Application for KarXT for the Treatment of Schizophrenia\nPrescription Drug User Fee Act (PDUFA) action date is September 26, 2024\nIf approved, KarXT would represent the first new pharmacological approach to treating schizophrenia in several decades\nThe application is supported by positive data from the EMERGENT clinical trial program showing KarXT is associated with significant improvements in schizophrenia symptoms\nBOSTON -- Nov. 29, 2023 -- Karuna Therapeu...