Seqens Seqens

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[{"orgOrder":0,"company":"Intra-Cellular Therapies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pivotal Study of CAPLYTA\u2122 (lumateperone) for the Treatment of Schizophrenia in Adults Published in JAMA Psychiatry","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Intra-Cellular Therapies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Intra-Cellular Therapies Announces Positive Top-line Results from ITI-214 Phase I\/II Study in Patients with Heart Failure","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Intra-Cellular Therapies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Intra-Cellular Therapies Announces Positive Results from Study 402 Evaluating Lumateperone as Adjunctive Therapy for Bipolar Depression","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Intra-Cellular Therapies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Intra-Cellular Therapies' CAPLYTA\u00ae Open-Label Safety Switching Study in Schizophrenia Published in the Journal, Schizophrenia Research","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase II"},{"orgOrder":0,"company":"Intra-Cellular Therapies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CAPLYTA\u00ae (Lumateperone) Schizophrenia Safety and Tolerability Profile Published in the Journal, International Clinical Psychopharmacology","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase II"},{"orgOrder":0,"company":"Intra-Cellular Therapies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Intra-Cellular Therapies Announces U.S. FDA Approval of CAPLYTA\u00ae (Lumateperone) for the Treatment of Bipolar Depression in Adults","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Intra-Cellular Therapies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Intra-Cellular Therapies Announces FDA Approval of New Dosage Strengths for CAPLYTA\u00ae (lumateperone) for Specific Patient Populations","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Intra-Cellular Therapies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Intra-Cellular Therapies Highlights New CAPLYTA Bipolar Depression Data Presentations at the American College of Neuropsychopharmacology 61st Annual Meeting","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Intra-Cellular Therapies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Intra-Cellular Therapies Announces Positive Topline Results from Study 403 Evaluating Lumateperone as Monotherapy in Patients with Major Depressive Disorder with Mixed Features and Bipolar Depression with Mixed Features","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Intra-Cellular Therapies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Intra-Cellular Therapies Announces Availability of CAPLYTA\u2122 (lumateperone) for Adult Patients with Schizophrenia","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Intra-Cellular Therapies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Intra-Cellular Therapies Initiates Promotional Activities for CAPLYTA\u2122 (lumateperone) for the Treatment of Schizophrenia in Adults","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Intra-Cellular Therapies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Intra-Cellular Therapies Announces FDA Acceptance of CAPLYTA\u00ae (lumateperone) sNDAs for the Treatment of Bipolar Depression","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Intra-Cellular Therapies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Intra-Cellular Therapies Applies for FDA Approval of CAPLYTA\u00ae (lumateperone) for the Treatment of Bipolar Depression","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Intra-Cellular Therapies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Intra-Cellular Therapies Highlights Lumateperone Bipolar Depression Data Presentations at the 2022 International Society for Bipolar Disorders (ISBD) Experience","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Intra-Cellular Therapies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Intra-Cellular Therapies Announces CAPLYTA Data Presentations at the American Society of Clinical Psychopharmacology Annual Meeting","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Intra-Cellular Therapies","sponsor":"J.P. Morgan","pharmaFlowCategory":"D","amount":"$500.0 million","upfrontCash":"Undisclosed","newsHeadline":"Intra-Cellular Therapies Announces Proposed Public Offering of Common Stock","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Intra-Cellular Therapies","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Intra-Cellular Therapies Announces Positive Phase 3 Topline Results from Study 501 Evaluating Lumateperone as Adjunctive Therapy in Patients with Major Depressive Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"}]

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            Details:

            The net proceeds will fund commercialization activities in connection with the continued commercialization of Caplyta (lumateperone), an antipsychotic drug, for the treatment of schizophrenia and for the treatment of bipolar depression.

            Lead Product(s): Lumateperone Tosylate

            Therapeutic Area: Psychiatry/Psychology Product Name: Caplyta

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: J.P. Morgan

            Deal Size: $500.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering April 16, 2024

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            Details:

            Caplyta (lumateperone) is an oral, once daily atypical antipsychotic that acts as a 5-HT2A & D2 receptor antagonist. It is being evaluated for the treatment of major depressive disorder.

            Lead Product(s): Lumateperone Tosylate

            Therapeutic Area: Psychiatry/Psychology Product Name: Caplyta

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 16, 2024

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            Details:

            Caplyta® (lumateperone) has a combination mechanism of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors. It is investigated for the treatment of bipolar I or bipolar II disorder.

            Lead Product(s): Lumateperone Tosylate

            Therapeutic Area: Psychiatry/Psychology Product Name: Caplyta

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 31, 2023

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            Caplyta® (lumateperone) has a combination mechanism of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors. It is used for the treatment of major depressive disorers.

            Lead Product(s): Lumateperone Tosylate

            Therapeutic Area: Psychiatry/Psychology Product Name: Caplyta

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 28, 2023

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            The results confirm the favorable effects of Caplyta (lumateperone) 42mg on body weight and morphology as demonstrated by minimal and similar to placebo mean changes from baseline in weight, BMI (kg/m2) and waist circumference in short-term studies.

            Lead Product(s): Lumateperone Tosylate

            Therapeutic Area: Psychiatry/Psychology Product Name: Caplyta

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 08, 2022

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            Details:

            Caplyta (lumateperone) has a combination mechanism of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central D2 receptors. It is investigated for major depressive episodes associated with bipolar I or II disorder.

            Lead Product(s): Lumateperone Tosylate

            Therapeutic Area: Psychiatry/Psychology Product Name: Caplyta

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 13, 2022

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            Details:

            CAPLYTA (lumateperone) label now includes dosage recommendations for specific patient populations; those with moderate or severe hepatic impairment and patients who are concomitantly taking moderate or strong CYP3A4 inhibitors.

            Lead Product(s): Lumateperone Tosylate

            Therapeutic Area: Psychiatry/Psychology Product Name: Caplyta

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 25, 2022

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            Details:

            CAPLYTA is the only medication approved by the FDA to treat depressive disorders associated with bipolar I or bipolar II as both monotherapy and adjunctive therapy with lithium or valproate. CAPLYTA demonstrated a favorable tolerability and safety profile.

            Lead Product(s): Lumateperone Tosylate

            Therapeutic Area: Psychiatry/Psychology Product Name: Caplyta

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 20, 2021

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            Details:

            CAPLYTA (lumateperone) is an oral, once daily atypical antipsychotic approved for the treatment of schizophrenia of adults. While the mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown.

            Lead Product(s): Lumateperone Tosylate

            Therapeutic Area: Psychiatry/Psychology Product Name: Caplyta

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 07, 2021

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            Details:

            Caplyta® (lumateperone) has a combination mechanism of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors. It is investigated for the treatment of Bipolar Depression.

            Lead Product(s): Lumateperone Tosylate

            Therapeutic Area: Psychiatry/Psychology Product Name: Caplyta

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 03, 2021

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