Karuna Therapeutics Inc

Karuna Therapeutics, Inc. operates as a clinical-stage biopharmaceutical company. engages in business of research and development of therapies utilizing muscarinic cholinergic receptors to treat psychosis and cognitive impairment in numerous central nervous system disorders. The company was founded by Andrew Miller, Eric Elenko, and Peter Jeffrey Conn in July 2009 and is headquartered in Boston, MA.

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Karuna Therapeutics reports positive trial results and strong financial outlook

Karuna Therapeutics is making significant progress in its key programs, with positive trial results and a focus on expanding its pipeline. Despite challenges in trial timelines and increased expenses, the company's strong financial position and strategic priorities position it well for future growth.

Karuna Therapeutics reports robust Q2 performance and eyes new indications

Karuna Therapeutics reported strong financials, progress on NDA submission, and ongoing Phase III programs.
The company's focus on cognitive benefits, broader efficacy, and potential new indications showcases strategic growth initiatives.
Challenges include competitive dynamics in Alzheimer's trials and uncertainties in the applicability of KarXT in certain patient populations.
Opportunities lie in exploring new indications, demonstrating cognitive benefits, and enhancing efficacy in mood and anxiety disorders.

Karuna Therapeutics excels in Q3, eyes global expansion for KarXT

Karuna Therapeutics demonstrated strong performance in Q3 with a focus on KarXT Phase III programs and NDA submission, supported by a healthy financial position.
Strategic strengths lie in maximizing KarXT value, positive payer interactions, and broad-based commercial strategies, while challenges include managing expenses and operational considerations.
Opportunities for growth include expanding the TRPC4/5 program, leveraging favorable mental health trends, and pursuing international market partnerships for KarXT.

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Karuna Therapeutics is a biopharmaceutical company that develops treatments for psychiatric and neurological conditions. Karuna Therapeutics creates drugs that can significantly improve the lives of people who suffer from neurological and psychiatric illnesses, with a particular focus on schizophrenia and the behavioral symptoms of Alzheimer's disease. The company is skilled in neuroscience and has creative ideas for finding and developing new drugs. Karuna Therapeutics is advancing a pipeline of innovative drugs since its inception with the aim of significantly improving the lives of people suffering from these difficult conditions.

If approved, Karuna's (KRTX) KarXT will be the first new mechanism of action to treat schizophrenia in several decades. A final decision is expected in September 2024.

FDA Accepts Karuna's (KRTX) NDA Filing for Schizophrenia Drug

PureTech Health PLC

BOSTON--(BUSINESS WIRE)--PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company, noted today that its Founded Entity, Karuna Therapeutics, Inc. (Nasdaq: KRTX) ("Karuna") announced the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for KarXT (xanomeline-trospium) for the treatment of schizophrenia in adults. The application has been granted a Prescription Drug User Fee Act (PDUFA) date of Septembe.

PureTech Founded Entity Karuna Therapeutics Announces U.S. Food and Drug Administration Accepts New Drug Application for KarXT for the Treatment of Schizophrenia

BOSTON--(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 the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for KarXT (xanomeline-trospium) for the treatment of schizophrenia in adults. The application has been granted a Prescription Drug User Fee Act (PDUFA) date of September.

Karuna Therapeutics Announces U.S. Food and Drug Administration Accepts New Drug Application for KarXT for the Treatment of Schizophrenia

Data from an early-stage study shows that treatment with Karuna's (KRTX) KarXT was not associated with clinically meaningful increases in blood pressure in schizophrenia patients.

Karuna (KRTX) Posts Upbeat Safety Data on Schizophrenia Drug

BOSTON--(BUSINESS WIRE)--PureTech Founded Entity Karuna Therapeutics Announces Positive Results from Ph 1b Ambulatory Blood Pressure Monitoring Trial of KarXT in Schizophrenia.

PureTech Founded Entity Karuna Therapeutics Announces Positive Results from Phase 1b Ambulatory Blood Pressure Monitoring Trial of KarXT in Schizophrenia

BOSTON--(BUSINESS WIRE)---- $KRTX--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 positive results from its Phase 1b open-label, eight-week inpatient trial evaluating the effect of KarXT (xanomeline-trospium) on 24-hour ambulatory blood pressure in adults with schizophrenia demonstrating that KarXT was not associated with increases in blo.

Karuna Therapeutics Announces Positive Results from Phase 1b Ambulatory Blood Pressure Monitoring Trial of KarXT in Schizophrenia

Karuna Therapeutics focuses on developing therapies that target muscarinic cholinergic receptors to treat psychosis and cognitive impairment in CNS disorders. The Company's lead asset, KarXT, has shown promising efficacy in phase III studies and has a unique mechanism of action compared to traditional antipsychotics. KarXT has potential applications in both schizophrenia and Alzheimer's disease psychosis, offering diversification to the investment thesis.

Karuna Therapeutics: Rewiring The Schizophrenia Paradigm - A Novel Leap Beyond Dopamine

Karuna Therapeutics, Inc. (NASDAQ:KRTX ) Q3 2023 Earnings Conference Call November 2, 2023 8:00 AM ET Company Participants Alexis Smith - Head of Corporate Affairs and IR Bill Meury - President and CEO Jason Brown - CFO Andrew Miller - Founder and COO Will Kane - Chief Commercial Officer Conference Call Participants Yatin Suneja - Guggenheim Securities Myles Minter - William Blair Paul Matteis - Stifel Ash Verma - UBS Mohit Bansal - Wells Fargo David Amsellem - Piper Sandler Jay Olson - Oppenheimer Jeff Hung - Morgan Stanley Jason Butler - JMP Securities Operator Welcome to the Karuna Therapeutics Third Quarter 2023 Financial Results Conference Call. All participants are in a listen-only mode.

Karuna Therapeutics, Inc. (KRTX) Q3 2023 Earnings Conference Call Transcript

Karuna's (KRTX) third-quarter 2023 earnings miss estimates. The company did not record any sales during the quarter.

Karuna's (KRTX) Q3 Loss Wider-Than-Expected, Sales Miss

BOSTON--(BUSINESS WIRE)---- $KRTX--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 financial results for the third quarter of 2023 and provided a general business update. “The third quarter was highlighted by our NDA submission to the FDA for KarXT for the treatment of schizophrenia, a significant milestone for Karuna, as well as for patie.

Karuna Therapeutics Reports Third Quarter 2023 Financial Results and Provides General Business Updates

BOSTON--(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 it will be presenting new efficacy, safety, and tolerability analyses from its EMERGENT program evaluating KarXT (xanomeline-trospium) in adults with schizophrenia at the upcoming Neuroscience Education Institute (NEI) Congress, to be held November 9-12, 202.

Karuna Therapeutics to Present Data from the EMERGENT Program Evaluating KarXT in Schizophrenia at the 2023 Neuroscience Education Institute Congress

BOSTON--(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 5th Annual Inflammation & Immunology Conference Date: Tuesday, November 7, 2023 Time: 1:50 p.m. ET Stifel 2023 Healthcare Conference Date: Tuesday, November 14, 2023.

Karuna Therapeutics to Present at Upcoming Investor Conferences

BOSTON--(BUSINESS WIRE)---- $KRTX--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 business update. A live webcast of the presentation will be available on the Investor Rela.

Karuna Therapeutics to Announce Third Quarter 2023 Financial Results and Provide General Business Update on Thursday, November 2, 2023

Karuna Therapeutics, Inc. stock had >8x gain after my Buy rating before successful Phase 3 trial data for KarXT in treating schizophrenia. The stock has pulled back and is at a good buy level ahead of the upcoming NDA decision (end of this year) and potential FDA approval for KarXT in 2024. KarXT has the potential to become a new standard of care for treating schizophrenia (a large target market), with several advantages over current treatments.

Karuna Therapeutics: KarXT Could Become A New Standard Of Care In Schizophrenia

BOSTON--(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 it will be presenting new secondary efficacy, safety and tolerability, and pooled cognition data from its EMERGENT clinical program evaluating KarXT (xanomeline-trospium) in schizophrenia. The data will be presented at the upcoming 36th European College of N.

Karuna Therapeutics to Present Data from the EMERGENT Program Evaluating KarXT in Schizophrenia at the 36th European College of Neuropsychopharmacology (ECNP) Congress

If approved, Karuna's (KRTX) KarXT will be the first new mechanism of action to treat schizophrenia in several decades. Data from three clinical studies support the FDA filing.

Karuna (KRTX) Submits NDA Filing to FDA for Schizophrenia Drug

Karuna Therapeutics asked the Food and Drug Administration to approve its schizophrenia treatment on Thursday, and KRTX stock jumped higher.

Karuna Takes A Big Step In Schizophrenia Treatment. Shares Jump Higher.

BOSTON--(BUSINESS WIRE)---- $KRTX--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 the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for KarXT (xanomeline-trospium) for the treatment of schizophrenia. "Schizophrenia is a serious mental illness that affects how one thinks, feels, and behaves, with.

Karuna Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for KarXT for the Treatment of Schizophrenia

Submission of New Drug Application of KarXT for the treatment of schizophrenia is expected in Q3, 2023. If FDA approval of KarXT is given for the treatment of patients with schizophrenia then commercial launch of the drug is expected in the second half of 2024. The global schizophrenia drug market is projected to reach $9.48 billion by 2026.

Karuna: NDA Filing Q3 Of 2023 And Expanded Potential With KarXT

Karuna Therapeutics develops innovative treatments for psychiatric and neurological disorders, with their investigational drug KarXT targeting schizophrenia and Alzheimer's-related psychosis. Karuna Therapeutics faced a net loss of $103.2M in Q2 2023, largely due to increased expenses in research and development, but finished the quarter with $1.4B in cash and equivalents. KarXT shows promising potential in treating schizophrenia and Alzheimer's-related psychosis, with upcoming clinical trial results and a projected NDA submission in 2023.

Karuna's Robust Liquidity Paves Way For KarXT Milestones (Rating Upgrade)

Karuna Therapeutics, Inc. (NASDAQ:KRTX ) Q2 2023 Earnings Conference Call August 3, 2023 8:00 AM ET Company Participants Alexis Smith - Senior Director of Investor Relations William Meury - President and Chief Executive Officer Troy Ignelzi - Chief Financial Officer Andrew Miller - Founder and Chief Operating Officer Conference Call Participants Paul Matteis - Stifel David Amsellem - Piper Sandler Myles Minter - William Blair Jason Butler - JMP Securities Guofang Li - Leerink Partners Jay Olson - Oppenheimer Yatin Suneja - Guggenheim Partners Laura Chico - Wedbush Securities Ram Selvaraju - H.C. Wainwright Jeff Hung - Morgan Stanley Operator Welcome to the Karuna Therapeutics Second Quarter 2023 Financial Results Conference Call.

Karuna Therapeutics, Inc. (KRTX) Q2 2023 Earnings Call Transcript

Karuna (KRTX) reports mixed second-quarter 2023 results. The company beats estimates for earnings but misses the mark on sales.

Karuna (KRTX) Reports Narrower-Than-Expected Loss in Q2

Karuna Therapeutics, Inc. (KRTX) came out with a quarterly loss of $2.75 per share versus the Zacks Consensus Estimate of a loss of $2.76. This compares to loss of $2.17 per share a year ago.

Karuna Therapeutics, Inc. (KRTX) Reports Q2 Loss, Lags Revenue Estimates

BOSTON--(BUSINESS WIRE)---- $KRTX--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 second quarter of 2023 and provided a general business update. “We've made significant progress in the second quarter across our business, but most importantly in generating, analyzing, and preparing the data required for our NDA.

Karuna Therapeutics Reports Second Quarter 2023 Financial Results and Provides General Business Updates

BOSTONBOSTON--(BUSINESS WIRE)---- $KRTX--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 Resources Officer (CHRO) and the promotion of Jason Brown to Chief Financial Officer (CFO). Mr. Brown succeeds Troy Ignelzi, who will remain at Karuna for a transition period through the end of the th.

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