Extrapyramidal symptoms

 Bristol Myers Squibb Presents New Pooled Interim Long-Term Safety and Metabolic Outcomes Data from the EMERGENT Program Evaluating KarXT in Schizophrenia at the 2024 Annual Congress of the Schizophrenia International Research Society

Retrieved on: 
Saturday, April 6, 2024
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Bristol Myers Squibb (NYSE: BMY) today announced interim long-term safety, tolerability and metabolic outcomes data from its Phase 3 EMERGENT program evaluating KarXT (xanomeline-trospium) in adults with schizophrenia.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced interim long-term safety, tolerability and metabolic outcomes data from its Phase 3 EMERGENT program evaluating KarXT (xanomeline-trospium) in adults with schizophrenia.
  • “These long-term safety results and metabolic outcomes from the EMERGENT program are extremely encouraging, allowing us to further understand the tolerability profile of KarXT in people living with schizophrenia,” said Roland Chen , MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience development, Bristol Myers Squibb.
  • In the pooled analysis, KarXT demonstrated a favorable impact on weight and long-term metabolic profile where most patients experienced stability or improvements on key metabolic parameters over 52 weeks of treatment.
  • In the long-term studies, KarXT was generally well-tolerated across 52 weeks of treatment, with a side effect profile consistent with prior trials of KarXT in schizophrenia.

PureTech Founded Entity Karuna Therapeutics to be Acquired by Bristol Myers Squibb for $14 Billion

Retrieved on: 
Friday, December 22, 2023
Neurology, Biotechnology, Pharmaceutical, General Health, Health, FDA, Mental Health, Clinical Trials, Akathisia, BMY, Conference, Cognition, Food, Bristol Myers Squibb, Simpson Thacher & Bartlett, Treatment, Drug development, Extrapyramidal symptoms, PRTC, Psychiatry, Bipolar I disorder, Acquisition, PDUFA, Psychosis, Conference call, NDA, KRTX, Prolactin, Citigroup, Therapy, Covington & Burling, M1, Goldman Sachs, Weight gain, Growth, Webcast, Patient, Safety, M4, Pharmaceutical industry

The transaction was unanimously approved by both the Bristol Myers Squibb and Karuna Boards of Directors.

Key Points: 
  • The transaction was unanimously approved by both the Bristol Myers Squibb and Karuna Boards of Directors.
  • ET
    PRINCETON, N.J. & BOSTON -- Bristol Myers Squibb (NYSE: BMY) and Karuna Therapeutics, Inc. (NASDAQ: KRTX) (“Karuna”) today announced that they have entered into a definitive merger agreement under which Bristol Myers Squibb has agreed to acquire Karuna for $330.00 per share in cash, for a total equity value of $14.0 billion, or $12.7 billion net of estimated cash acquired.
  • The transaction was unanimously approved by both the Bristol Myers Squibb and Karuna Boards of Directors.
  • Gordon Dyal & Co. and Citi are serving as financial advisors to Bristol Myers Squibb, and Covington & Burling LLP is serving as legal counsel.

Bristol Myers Squibb Strengthens Neuroscience Portfolio with Acquisition of Karuna Therapeutics

Retrieved on: 
Friday, December 22, 2023
Biotechnology, Neurology, Mental Health, Health, Pharmaceutical, Akathisia, BMY, Cognition, Food, Bristol Myers Squibb, Simpson Thacher & Bartlett, Drug development, Extrapyramidal symptoms, Psychiatry, Bipolar I disorder, FDA, Acquisition, PDUFA, Psychosis, NDA, KRTX, Prolactin, Citigroup, Therapy, Schizophrenia, Covington & Burling, M1, Goldman Sachs, Weight gain, Growth, Webcast, Patient, Safety, M4, Pharmaceutical industry

Bristol Myers Squibb (NYSE: BMY) and Karuna Therapeutics, Inc. (NASDAQ: KRTX) (“Karuna”) today announced that they have entered into a definitive merger agreement under which Bristol Myers Squibb has agreed to acquire Karuna for $330.00 per share in cash, for a total equity value of $14.0 billion, or $12.7 billion net of estimated cash acquired.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) and Karuna Therapeutics, Inc. (NASDAQ: KRTX) (“Karuna”) today announced that they have entered into a definitive merger agreement under which Bristol Myers Squibb has agreed to acquire Karuna for $330.00 per share in cash, for a total equity value of $14.0 billion, or $12.7 billion net of estimated cash acquired.
  • The transaction was unanimously approved by both the Bristol Myers Squibb and Karuna Boards of Directors.
  • “There are tremendous opportunities in neuroscience, and Karuna strengthens our position and accelerates the expansion and diversification of our portfolio in the space.
  • Gordon Dyal & Co. and Citi are serving as financial advisors to Bristol Myers Squibb, and Covington & Burling LLP is serving as legal counsel.

Bristol Myers Squibb Strengthens Neuroscience Portfolio with Acquisition of Karuna Therapeutics

Retrieved on: 
Friday, December 22, 2023
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Bristol Myers Squibb (NYSE: BMY) and Karuna Therapeutics, Inc. (NASDAQ: KRTX) (“Karuna”) today announced that they have entered into a definitive merger agreement under which Bristol Myers Squibb has agreed to acquire Karuna for $330.00 per share in cash, for a total equity value of $14.0 billion, or $12.7 billion net of estimated cash acquired.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) and Karuna Therapeutics, Inc. (NASDAQ: KRTX) (“Karuna”) today announced that they have entered into a definitive merger agreement under which Bristol Myers Squibb has agreed to acquire Karuna for $330.00 per share in cash, for a total equity value of $14.0 billion, or $12.7 billion net of estimated cash acquired.
  • The transaction was unanimously approved by both the Bristol Myers Squibb and Karuna Boards of Directors.
  • “There are tremendous opportunities in neuroscience, and Karuna strengthens our position and accelerates the expansion and diversification of our portfolio in the space.
  • Gordon Dyal & Co. and Citi are serving as financial advisors to Bristol Myers Squibb, and Covington & Burling LLP is serving as legal counsel.

KarXT, invented at PureTech, submitted for FDA Approval in Schizophrenia

Retrieved on: 
Thursday, September 28, 2023
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“We are thrilled to note this additional exciting milestone from the KarXT program, following the achievement of three successful, registration enabling studies in schizophrenia.

Key Points: 
  • “We are thrilled to note this additional exciting milestone from the KarXT program, following the achievement of three successful, registration enabling studies in schizophrenia.
  • 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 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.
  • Discontinuation rates due to treatment emergent adverse events were low and similar between KarXT and placebo across all trials.

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

Retrieved on: 
Thursday, September 28, 2023
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It is also a defining moment for Karuna Therapeutics.

Key Points: 
  • It is also a defining moment for Karuna Therapeutics.
  • 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.
  • Discontinuation rates due to treatment emergent adverse events were low and similar between KarXT and placebo across all trials.
  • Notably, KarXT was not associated with common side effects of currently available antipsychotics, including changes in metabolic function, weight gain, somnolence, and extrapyramidal symptoms.

Accord Healthcare Offers Generic Option for Treatment of Schizophrenia and Bipolar Depression

Retrieved on: 
Tuesday, February 21, 2023
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DURHAM, N.C., Feb. 21, 2023 /PRNewswire/ -- Accord Healthcare, Inc. , a leading generic pharmaceutical company, has added Lurasidone HCL tablets to its line of generic drugs.

Key Points: 
  • DURHAM, N.C., Feb. 21, 2023 /PRNewswire/ -- Accord Healthcare, Inc. , a leading generic pharmaceutical company, has added Lurasidone HCL tablets to its line of generic drugs.
  • Lurasidone is an oral, atypical antipsychotic, which is a first-line treatment option for the management of schizophrenia in adults and adolescents.
  • "A generic option in mental health treatment provides more accessible healthcare to those who are in need."
  • Adverse reactions 2 of lurasidone for treatment of schizophrenia and bipolar depression include somnolence, akathisia, which is a feeling of restlessness, anxiety, and/or agitation, and extrapyramidal symptoms.

Cerevel Therapeutics Announces Publication in The Lancet of Emraclidine Data from Phase 1b Clinical Trial in People Living with Schizophrenia

Retrieved on: 
Thursday, December 15, 2022
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CAMBRIDGE, Mass., Dec. 15, 2022 (GLOBE NEWSWIRE) -- Cerevel Therapeutics (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, announced today the publication of data from its Phase 1b clinical trial of emraclidine, a novel muscarinic M4 selective positive allosteric modulator, in adults living with schizophrenia in The Lancet.

Key Points: 
  • Recently, in order to accelerate a potentially registrational package for emraclidine in schizophrenia, the company also initiated EMPOWER-3, a 52-week open-label safety extension trial.
  • This two-part, phase 1b trial was designed to assess the safety and tolerability of emraclidine in people living with schizophrenia.
  • The first part of the trial (part A) was a multiple ascending-dose design to establish safety, tolerability, and appropriate dosing based on pharmacokinetics.
  • Current pharmacologic treatments for schizophrenia primarily target excessive striatal dopaminergic signaling by directly antagonizing postsynaptic dopamine D2 receptor subtypes.

USPTO Grants New Patent to Evoke Pharma Covering the Usage of GIMOTI® To Treat Moderate to Severe Gastroparesis

Retrieved on: 
Wednesday, December 7, 2022
NMS, Depression, Metoclopramide, Absorption, Suicidal ideation, EPS, Fatigue, Physiology, Evoke, Tardive dyskinesia, Gastroparesis, MBA, Neuroleptic malignant syndrome, Creatinine, COVID-19, Parkinsonism, Dysgeusia, Food, FDA, Patent, Risk, Internal bleeding, Perforation, Methemoglobinemia, Hypersensitivity, Extrapyramidal symptoms, Water, Moderate, Hypertension, Neoplasm, Orange Book, Bronchospasm, Epilepsy, Liver, Seizure, Patient, Kidney, United, Catecholamine, TD, Headache, Pheochromocytoma, Suicide, Stomach, Hyperprolactinaemia, History, CYP2D6, Pharmaceutical industry, Aroma compound, Residential care, Generic drug, EU
Key Points: 

    Evoke Pharma Strengthens its Intellectual Property Portfolio with a Notice of Allowance from the USPTO for a Patent Application Related to GIMOTI®

    Retrieved on: 
    Wednesday, November 30, 2022
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    This patent application is a continuation of several other U.S. patent applications filed by the company over the last decade.

    Key Points: 
    • This patent application is a continuation of several other U.S. patent applications filed by the company over the last decade.
    • We are thrilled and highly encouraged by the strides we have made with the USPTO and its continued acknowledgement of the novel and inventive nature of GIMOTI, said Matt DOnofrio, Chief Business Officer of Evoke Pharma.
    • Most common adverse reactions (5%) for GIMOTI are: dysgeusia, headache, and fatigue.These are not all of the possible side effects of GIMOTI.
    • Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects.