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Karuna Therapeutics said Monday that its treatment for schizophrenia reduced psychosis reported by patients — achieving the main goal of a large clinical trial and supporting similarly positive results from previously conducted studies.

The company intends to file a marketing application for its drug, called KarXT, with the Food and Drug Administration by the middle of the year. If approved, the Karuna drug would usher in the first new class of medicines for the treatment of schizophrenia in decades.


“KarXT could profoundly change the standard of care, and I think the psychiatric community is anticipating it,” Karuna CEO Bill Meury told STAT.

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