Press Releases

Prescription Drug User Fee Act (PDUFA) action date is September 26, 2024 If approved, KarXT would represent the first new pharmacological approach to treating schizophrenia in several decades The application is supported by positive data from the EMERGENT clinical trial program showing KarXT is

Results demonstrate KarXT was not associated with clinically meaningful increases in blood pressure in adults with schizophrenia KarXT demonstrated a mean change from baseline to week 8 in 24-hour ambulatory systolic blood pressure of -0.59 mmHg, the primary endpoint in the trial KarXT was

Submitted New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for KarXT for the treatment of schizophrenia in the third quarter of 2023 Initiated the Phase 3 ADEPT-2 and ADEPT-3 trials evaluating KarXT for the treatment of psychosis in Alzheimer’s disease in the third quarter

Analyses of pooled efficacy data from the EMERGENT program demonstrate significant improvements in schizophrenia symptoms Analyses extend prior findings that KarXT is generally well tolerated with a low risk of common adverse events associated with current antipsychotics, including somnolence,

BOSTON --(BUSINESS WIRE)--Nov. 1, 2023-- Karuna Therapeutics, Inc. (NASDAQ: KRTX), a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced that management will present at the

BOSTON --(BUSINESS WIRE)--Oct. 19, 2023-- Karuna Therapeutics, Inc. (NASDAQ: KRTX), a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced that it will host a live conference call

New efficacy, safety and tolerability analyses from the EMERGENT-3 trial support KarXT's potential as a new treatment option for schizophrenia Exploratory analysis will examine KarXT's impact on cognition in patients with schizophrenia in the EMERGENT-2 and EMERGENT-3 trials Company submitted New

KarXT, a dual M1/M4 muscarinic agonist, represents the first new mechanism of action to treat schizophrenia in several decades, if approved Submission is supported by data from three positive registrational trials demonstrating consistent and robust reductions of schizophrenia symptoms BOSTON

BOSTON --(BUSINESS WIRE)--Aug. 30, 2023-- Karuna Therapeutics, Inc. (NASDAQ: KRTX), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced that management will present at the

On track to submit New Drug Application (NDA) for KarXT in schizophrenia with the U.S. FDA in the third quarter of 2023, with a product launch in the second half of 2024, assuming approval Initiated the Phase 3 ADEPT-3 open label extension trial in the third quarter of 2023, and on track to