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Details:
Lumateperone tosylate capsule 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 Schizophrenia.
Lead Product(s): Lumateperone Tosylate
Therapeutic Area: Psychiatry/Psychology Product Name: Caplyta-Generic
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2023
Details:
The intend to use the net proceeds from this offering to fund commercialization activities of Caplyta (lumateperone), which is indicated for the treatment of schizophrenia.
Lead Product(s): Lumateperone Tosylate
Therapeutic Area: Psychiatry/Psychology Product Name: Caplyta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: J.P. Morgan
Deal Size: $575.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering April 24, 2024
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: J.P. Morgan
Deal Size: $500.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering April 17, 2024
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: J.P. Morgan
Deal Size: $500.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering April 16, 2024
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2024
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2023
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 used for the treatment of major depressive disorers.
Lead Product(s): Lumateperone Tosylate
Therapeutic Area: Psychiatry/Psychology Product Name: Caplyta
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2023
Details:
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 08, 2022
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 13, 2022
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 25, 2022
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 20, 2021
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 IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 07, 2021
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2021
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2021
Details:
Patients with stable symptoms of schizophrenia were switched from previous antipsychotic medications with no dose titration to CAPLYTA 42 mg for a 6-week treatment duration, then switched back to previous or another approved antipsychotic.
Lead Product(s): Lumateperone Tosylate
Therapeutic Area: Psychiatry/Psychology Product Name: Caplyta
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 21, 2021
Details:
Lumateperone 42 mg achieved statistically significant results in primary and key secondary endpoints in Study 402. Company expects to submit supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) in late 2020 or early 2021.
Lead Product(s): Lumateperone Tosylate
Therapeutic Area: Psychiatry/Psychology Product Name: Caplyta
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2020
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 used for the treatment of Schizophrenia.
Lead Product(s): Lumateperone Tosylate
Therapeutic Area: Psychiatry/Psychology Product Name: Caplyta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 02, 2020
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 used for the treatment of Schizophrenia.
Lead Product(s): Lumateperone Tosylate
Therapeutic Area: Psychiatry/Psychology Product Name: Caplyta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2020
Details:
In this trial, CAPLYTA 42 mg met the primary endpoint and demonstrated antipsychotic efficacy with statistically significant superiority over placebo at Week 4.
Lead Product(s): Lumateperone Tosylate
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 20, 2020
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