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Karuna Therapeutics said Monday that a novel combination pill reduced psychosis and related symptoms experienced by patients with schizophrenia, achieving the main goals of a late-stage clinical trial.

With positive study results in hand, the Boston-based biotech intends to submit a marketing application with the Food and Drug Administration by the middle of next year. If approved, the Karuna drug would usher in the first new class of medicines for the treatment of schizophrenia in decades.


Called KarXT, the Karuna drug targets muscarinic acetylcholine receptors in the brain to reduce psychotic symptoms. Current antipsychotics — which mostly block dopamine receptors — have become blockbuster schizophrenia medicines despite causing troubling side effects like weight gain and somnolence. Peak sales for KarXT could also reach into the billions of dollars, analysts forecast.

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