New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults under review with a Prescription Drug User Fee Act (PDUFA) action date of September 26, 2024 Results from the Phase 3 EMERGENT-2 trial of KarXT in schizophrenia published in The Lancet Announced appointments of Andrew Miller, Ph.D. as President of Research and Development and Mia Kelley, J.D. as General Counsel Previously announced proposed... Read More

KarXT demonstrated statistically significant and clinically meaningful improvements in positive and negative symptoms of schizophrenia compared to placebo, as measured by primary and secondary endpoints KarXT was generally well tolerated and not associated with many adverse events typically associated with current antipsychotics, including somnolence, weight gain and extrapyramidal symptoms New Drug Application for KarXT for... Read More

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 associated with significant improvements in schizophrenia symptoms BOSTON / Nov 29, 2023 / Business Wire / Karuna Therapeutics, Inc.... Read More

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 generally well tolerated, with a side effect profile consistent with prior trials in the EMERGENT program evaluating KarXT in... Read More

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 of 2023 $1.3 billion in cash expected to fund operations through 2026 Conference call and webcast to take place today at 8:00... Read More

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, weight gain, and movement disorders Company submitted New Drug Application (NDA) for KarXT for the treatment of schizophrenia to the... Read More

BOSTON / Nov 01, 2023 / Business Wire / 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 following upcoming investor conferences: Guggenheim 5 th Annual Inflammation & Immunology Conference Date: Tuesday, November 7, 2023... Read More

BOSTON / Oct 19, 2023 / Business Wire / 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 and webcast on Thursday, November 2, 2023 at 8:00 a.m. ET to review third quarter 2023 financial results and provide a general... Read More

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 Drug Application (NDA) for KarXT, which includes data from the EMERGENT program, to the U.S. Food & Drug Administration (FDA) in... Read More

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 / Sep 28, 2023 / Business Wire / Karuna Therapeutics, Inc. (NASDAQ: KRTX), a biopharmaceutical company driven to discover, develop,... Read More

BOSTON / Aug 30, 2023 / Business Wire / 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 following upcoming investor conferences: 2023 Wells Fargo Healthcare Conference Date: Wednesday, September 6, 2023 Time: 3:45 p.m. ET... Read More

Jonathan Rosin appointed to Chief Human Resources Officer Jason Brown promoted to Chief Financial Officer BOSTONBOSTON / Aug 03, 2023 / Business Wire / 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 the appointment of Jonathan Rosin to Chief Human... Read More

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 commence the Phase 3 ADEPT-2 trial in the second half of 2023 Announced the appointment of Jonathan Rosin to Chief Human Resources... Read More

BOSTON / Jul 20, 2023 / Business Wire / 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 it will host a live conference call and webcast on Thursday, August 3, 2023 at 8:00 a.m. ET to review second quarter 2023 financial results and provide a general... Read More

BOSTON / May 30, 2023 / Business Wire / 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 Goldman Sachs 44 th Annual Global Healthcare Conference on Monday, June 12, 2023, at 2:40 p.m. PT (5:40 p.m. ET). A live webcast of... Read More

BOSTON / May 22, 2023 / Business Wire / 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 data from the EMERGENT-1, EMERGENT-2, and EMERGENT-3 trials evaluating KarXT in schizophrenia will be presented at the American Society of Clinical... Read More

Announced positive topline data from the Phase 3 EMERGENT-3 trial of KarXT in schizophrenia in the first quarter of 2023 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 launch in the second half of 2024, if approved Phase 3 ADEPT-2 and ADEPT-3 trials of KarXT in psychosis in Alzheimer’s disease to initiate in the second half of 2023 $1.5 billion... Read More

BOSTON / May 02, 2023 / Business Wire / 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 following upcoming investor conferences: BofA Securities 2023 Health Care Conference Date: Wednesday, May 10, 2023 Time: 5:00 p.m. PT... Read More

Conference call and webcast to take place on Thursday, May 4, 2023 at 8:00 a.m. ET BOSTON / Apr 20, 2023 / Business Wire / 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 it will host a live conference call and webcast on Thursday, May 4, 2023 at 8:00... Read More

BOSTON / Mar 24, 2023 / Business Wire / Karuna Therapeutics, Inc. (NASDAQ: KRTX) (“Karuna”), a clinical-stage biopharmaceutical company driven to create and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced the closing of its previously announced underwritten public offering of 2,851,299 shares of common stock, which includes the exercise in full by the... Read More

BOSTON / Mar 23, 2023 / Business Wire / 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 Stifel 2023 CNS Days on Wednesday, March 29, 2023, at 8:00 a.m. ET. A live webcast of the presentation will be available on the... Read More

BOSTON / Mar 21, 2023 / Business Wire / 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 the pricing of an underwritten public offering of 2,479,391 shares of its common stock at a public offering price of $161.33 per share. The gross proceeds to Karuna from... Read More

BOSTON / Mar 20, 2023 / Business Wire / 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 it has commenced an underwritten public offering of $400.0 million of its common stock. Karuna also intends to grant the underwriters a 30-day option to purchase an... Read More

BOSTON / Mar 20, 2023 / Business Wire / 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 positive topline results from its Phase 3 EMERGENT-3 trial evaluating the efficacy, safety, and tolerability of its lead investigational therapy, KarXT... Read More

BOSTON / Feb 23, 2023 / Business Wire / 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 financial results for the fourth quarter and full year ended December 31, 2022, and provided a general business update. "A great deal was accomplished in 2022, which is... Read More

BOSTON / Feb 09, 2023 / Business Wire / 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 SVB Securities Global Biopharma Conference on Tuesday, February 14, 2023, at 2:20 p.m. EST. A live webcast of the presentation will... Read More

BOSTON / Jan 31, 2023 / Business Wire / 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 the appointment of Will Kane as chief commercial officer (CCO), effective February 6, 2023. “ The addition of Will to our executive team represents an important step as... Read More

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 Bill Meury, president and chief executive officer, will present at the 41 st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2023, at 9:00 a.m. PST (12:00 p.m. EST). A live webcast of the... Read More

Mr. Meury is a distinguished pharmaceutical leader with more than 25 years of operational and commercial experience delivering transformative medicines to patients Succeeds current president, chief executive officer, and chairman, Steve Paul, M.D., who will transition to president of research and development and chief scientific officer Christopher Coughlin to assume role of chairman of the board BOSTON--( BUSINESS WIRE )--... Read More