KRTX - FDA accepts Karuna Therapeutics' schizophrenia drug for review
2023-11-29 07:16:58 ET
The U.S. Food and Drug Administration has accepted Karuna Therapeutics' ( NASDAQ: KRTX ) new drug application for its lead candidate, KarXT.
KarXT (xanomeline-trospium) is an investigational muscarinic antipsychotic in development for the treatment of schizophrenia and psychosis related to Alzheimer's disease.
The application is backed by positive data from the EMERGENT clinical trial program showing KarXT is associated with significant improvements in schizophrenia symptoms.
"We are pleased the NDA for KarXT has been accepted, and we look forward to working with the FDA during the review process. There is a significant need for new treatment options for serious mental illness. If approved, KarXT could be one of the more important new product introductions in neuropsychiatry by providing a novel pharmacological approach for the treatment of schizophrenia," said Bill Meury, president and chief executive officer of Karuna Therapeutics.
The FDA has until September 26, 2024 to respond to the application.
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FDA accepts Karuna Therapeutics' schizophrenia drug for review