KarXT

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

Retrieved on: 
Wednesday, November 29, 2023
FDA, Pharmaceutical, Health, Mental Health, NDA, Neuropsychiatry, DSM-IV codes, KRTX, Safety, Employment, Food, Therapy, PureTech Health, Risk, PANSS, LSE, Nature, PRTC, Weight gain, New Drug Application, Master of Education, Housing, PDUFA, Psychiatry, Somnolence, Life, Pharmaceutical industry, Schizophrenia, KarXT

The application has been granted a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024.

Key Points: 
  • The application has been granted a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024.
  • The NDA submission is supported by efficacy and long-term safety data from the EMERGENT program, the clinical program evaluating KarXT as a treatment for schizophrenia.
  • PureTech is a founder of Karuna and co-inventor of the KarXT program.
  • If approved, KarXT will be the third therapeutic candidate to be taken from inception at PureTech to FDA regulatory approval.

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

Retrieved on: 
Wednesday, November 29, 2023
Mental Health, Health, FDA, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, NDA, Neuropsychiatry, DSM-IV codes, KRTX, Safety, Employment, Food, Therapy, Risk, PANSS, Nature, Weight gain, New Drug Application, Master of Education, Housing, Psychiatry, PDUFA, Somnolence, Life, Pharmaceutical industry, Schizophrenia, KarXT

The application has been granted a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024.

Key Points: 
  • The application has been granted a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024.
  • “We are pleased the NDA for KarXT has been accepted, and we look forward to working with the FDA during the review process,” said Bill Meury, president and chief executive officer of Karuna Therapeutics.
  • “Diagnosis marks the beginning of an often long and tiresome search for effective and tolerable treatment options.
  • Notably, KarXT was not associated with common side effects of currently available antipsychotics, including weight gain, somnolence, and movement disorders.

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

Retrieved on: 
Thursday, November 16, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, NDA, KRTX, Schizophrenia, Safety, Therapy, Assessment, BID, FDA, Heart rate, Diagnosis, Mercury (element), Psychiatry, Blood pressure, Pharmaceutical industry, KarXT

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 blood pressure.

Key Points: 
  • 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 blood pressure.
  • The primary endpoint in the trial was the change from baseline at week 8 in 24-hour average ambulatory systolic blood pressure.
  • In the trial, KarXT demonstrated a mean change from baseline to week 8 in 24-hour ambulatory systolic blood pressure of -0.59 mmHg.
  • Additional vital sign measures collected in the trial, including 24-hour average diastolic blood pressure and heart rate, were consistent with prior trials of KarXT in schizophrenia.

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

Retrieved on: 
Friday, November 17, 2023
Cardiology, Biotechnology, Pharmaceutical, General Health, Health, FDA, Mental Health, Clinical Trials, NDA, KRTX, Schizophrenia, Safety, Food, Therapy, PureTech Health, Assessment, LSE, BID, Heart rate, PRTC, New Drug Application, Diagnosis, Mercury (element), Psychiatry, Blood pressure, Pharmaceutical industry, KarXT

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company, noted that its Founded Entity, Karuna Therapeutics (NASDAQ: KRTX), 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 blood pressure.

Key Points: 
  • PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company, noted that its Founded Entity, Karuna Therapeutics (NASDAQ: KRTX), 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 blood pressure.
  • The primary endpoint in the trial was the change from baseline at week 8 in 24-hour average ambulatory systolic blood pressure.
  • In the trial, KarXT demonstrated a mean change from baseline to week 8 in 24-hour ambulatory systolic blood pressure of -0.59 mmHg.
  • In the trial, KarXT demonstrated a mean change from baseline to week 8 in 24-hour ambulatory systolic blood pressure of -0.59 mmHg.

PureTech's LYT-300 (Oral Allopregnanolone) Achieved Primary Endpoint in a Phase 2a Acute Anxiety Trial in Healthy Volunteers

Retrieved on: 
Tuesday, November 14, 2023
Mental Health, Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, CNS, Allopregnanolone, Schizophrenia, Daphne, Trier social stress test, PureTech Health, Anxiety, Neurosteroid, Patient, Multimedia, LSE, KarXT, Alprazolam, PRTC, Psychiatry, FRCPC, Epilepsy, Pharmacology, Therapy, Benzodiazepine, Stress-related disorders, DSM-IV codes, MPH, University, TSST, Massachusetts General Hospital, Public health, Glyph, Central nervous system, Volunteering, Hospital, Pharmaceutical industry, MD

The trial was designed to evaluate the salivary cortisol response in the Trier Social Stress Test (TSST), a validated clinical model of anxiety in healthy volunteers.

Key Points: 
  • The trial was designed to evaluate the salivary cortisol response in the Trier Social Stress Test (TSST), a validated clinical model of anxiety in healthy volunteers.
  • View the full release here: https://www.businesswire.com/news/home/20231113556006/en/
    PureTech announced topline results from its Phase 2a, randomized, placebo-controlled, proof-of-concept trial of LYT-300 (oral allopregnanolone).
  • The trial was designed to evaluate the salivary cortisol response in the Trier Social Stress Test (TSST), a validated clinical model of anxiety in healthy volunteers.
  • An increase in cortisol levels after the TSST is a physiological response and an objective biomarker of acute stress.

Royalty Pharma Reports Third Quarter 2023 Results

Retrieved on: 
Wednesday, November 8, 2023
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Drivers of total royalty receipts in the third quarter of 2023 are discussed below, based on commentary from the marketers of the products underlying the royalties in the preceding quarter (as royalty receipts generally lag product performance by one calendar quarter).

Key Points: 
  • Drivers of total royalty receipts in the third quarter of 2023 are discussed below, based on commentary from the marketers of the products underlying the royalties in the preceding quarter (as royalty receipts generally lag product performance by one calendar quarter).
  • Royalty Pharma acquired the Spinraza royalty in the first quarter of 2023.
  • In September 2023, Royalty Pharma acquired a royalty interest in Skytrofa from Ascendis Pharma A/S ( press release ) for an upfront payment of $150 million.
  • During the third quarter of 2023, Royalty Pharma repurchased approximately five million shares for $144 million.

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

Retrieved on: 
Thursday, November 2, 2023
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, KRTX, Psychiatry, Psychosis, Congress, ECNP, Schizophrenia, European College of Neuropsychopharmacology, NDA, Therapy, Patient, Cognition, Pharmaceutical industry, KarXT, PANSS

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.

Key Points: 
  • 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.
  • Submitted an NDA to the FDA for KarXT for the treatment of schizophrenia in adults in the third quarter of 2023.
  • General and administrative expenses were $32.3 million for the third quarter of 2023, as compared to $19.1 million for the prior year period.
  • The third quarter 2023 financial results and business update will be discussed during a conference call and webcast today at 8:00 a.m.

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

Retrieved on: 
Wednesday, November 1, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, Randomness, KRTX, Psychiatry, NEI, Therapy, Congress, Safety, Date-time group, Date, NDA, User experience, Patient, Sam Nda-Isaiah, Pharmaceutical industry, Communications satellite, KarXT, Schizophrenia

These new findings bolster KarXT’s earlier data, demonstrating clinically meaningful symptom reduction along with strong tolerability,” said Stephen Brannan, M.D., chief medical officer of Karuna Therapeutics.

Key Points: 
  • These new findings bolster KarXT’s earlier data, demonstrating clinically meaningful symptom reduction along with strong tolerability,” said Stephen Brannan, M.D., chief medical officer of Karuna Therapeutics.
  • In September 2023, the company filed an NDA for KarXT for the treatment of schizophrenia in adults to the U.S. FDA.
  • The NDA submission is supported by efficacy and long-term safety data from the EMERGENT program, the clinical program evaluating KarXT as a treatment for schizophrenia.
  • The EMERGENT program includes the three completed positive EMERGENT-1, EMERGENT-2, and EMERGENT-3 trials evaluating the efficacy and safety of KarXT compared to placebo, and the EMERGENT-4 and EMERGENT-5 trials evaluating the long-term safety of KarXT.

PureTech to Present at Two Upcoming Investor Conferences

Retrieved on: 
Tuesday, October 17, 2023
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PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that members of the management team will participate in fireside chats at two upcoming investor conferences.

Key Points: 
  • PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that members of the management team will participate in fireside chats at two upcoming investor conferences.
  • “Recently, we have been increasing our focus on our central nervous system (CNS) programs, including LYT-300 and LYT-310, that originated from our Glyph™ technology platform.
  • If approved, KarXT, invented at PureTech, will be the third therapeutic candidate to be taken from inception at PureTech to FDA regulatory approval.
  • PureTech will not move forward with the contemplated plan of merger with Gelesis and will instead focus on other strategic business initiatives.

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

Retrieved on: 
Wednesday, October 4, 2023
Mental Health, Research, Neurology, Clinical Trials, Biotechnology, Managed Care, Health, Pharmaceutical, Science, KRTX, Psychiatry, Cognition, Schizophrenia, Congress, European College of Neuropsychopharmacology, ECNP, KarXT, Therapy, Safety, Pharmaceutical industry

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.

Key Points: 
  • 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 Neuropsychopharmacology (ECNP) Congress, to be held October 7-10, 2023, in Barcelona, Spain.
  • “We’re eager to share these latest results, which further support KarXT’s differentiated safety and tolerability profile demonstrated in trials conducted to date and reinforce its potential to provide a broad range of clinically meaningful symptom improvements,” said Stephen Brannan, M.D., chief medical officer of Karuna Therapeutics.
  • “The complex challenges of schizophrenia underscore the urgent need for innovation.