Psychiatry/Psychology | Phase III Developments | UNITED STATES

Axsome Therapeutics

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Axsome reports late-stage depression trial defeat, shares wilt

Lead Product(s): Bupropion,Dextromethorphan

Therapeutic Area: Psychiatry/Psychology

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 30, 2020

Details:

A 312-subject Phase 3 clinical trial, STRIDE-1 in patients with treatment-resistant depression failed to achieve the primary endpoint.

VistaGen Therapeutics

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VistaGen Therapeutics Announces Common Stock Purchase Agreement for up to $10.25 Million

Lead Product(s): Aloradine

Therapeutic Area: Psychiatry/Psychology

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Lincoln Park Capital Fund

Deal Size: $10.2 million Upfront Cash: Undisclosed

Deal Type: Agreement March 25, 2020

Details:

VistaGen plans to use proceeds for general corporate purposes, including ongoing preparation for Phase 3 clinical development of PH94B neuroactive nasal spray.

BioXcel Therapeutics

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BioXcel Therapeutics Provides an Update on its Ongoing Phase 3 SERENITY Trials

Lead Product(s): Dexmedetomidine

Therapeutic Area: Psychiatry/Psychology

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 19, 2020

Details:

More than one-third of the SERENITY I & II patients have been dosed, including over 100 bipolar patients.

Sage Therapeutics

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Sage to run 3 new studies to save once-failed depression drug

Lead Product(s): SAGE-217

Therapeutic Area: Psychiatry/Psychology

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 18, 2020

Details:

Expected regulatory pathway for episodic treatment of major depression remains unchanged with plan for one new additional efficacy study.

Adial Pharmaceuticals

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Adial Pharmaceuticals Announces Modifications to the Phase 3 Pivotal Trial

Lead Product(s): Ondansetron

Therapeutic Area: Psychiatry/Psychology

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 17, 2020

Details:

Company is modifying its pivotal Phase 3 clinical trial of the Company's lead drug candidate, AD04, for the treatment of alcohol use disorder (AUD) in genetically targeted patients.

Sage Therapeutics

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Sage rethinks SAGE-217 program after phase 3 failure

Lead Product(s): SAGE-217

Therapeutic Area: Psychiatry/Psychology

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 February 27, 2020

Details:

The company will be evaluating path forward for the zuranolone (SAGE-217) Landscape Program.

Intra-Cellular Therapies

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Pivotal Study of CAPLYTA™ (lumateperone) for the Treatment of Schizophrenia in Adults Published in JAMA Psychiatry

Lead Product(s): Lumateperone

Therapeutic Area: Psychiatry/Psychology

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 February 20, 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.

Adamis Pharmaceuticals

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Adamis Pharmaceuticals Provides Update Regarding ZIMHI

Lead Product(s): Naloxone

Therapeutic Area: Psychiatry/Psychology

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 February 19, 2020

Details:

At the face to face meeting, the Company obtained concurrence from the agency on the Chemistry, Manufacturing and Controls (CMC) information required for resubmission of the NDA.

BioXcel Therapeutics

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BioXcel Therapeutics Initiates Phase 2 Study Designed to Assess Agitation-Associated Biomarkers and their Response to BXCL501

Lead Product(s): Dexmedetomidine

Therapeutic Area: Psychiatry/Psychology

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 February 18, 2020

Details:

The Phase 2 study by researchers at Yale University is designed to measure biomarkers associated with agitation in patients with schizophrenia and the response to treatment with BXCL501.

Biohaven Pharmaceuticals

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Biohaven anxiety treatment fails late-stage study, shares fall 16%

Lead Product(s): Trigriluzole

Therapeutic Area: Psychiatry/Psychology

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 February 10, 2020

Details:

In the study, patients receiving the experimental drug, troriluzole, twice everyday did not show improvement in anxiety symptoms, compared to a placebo.

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Axsome Therapeutics

Axsome reports late-stage depression trial defeat, shares wilt

VistaGen Therapeutics

VistaGen Therapeutics Announces Common Stock Purchase Agreement for up to $10.25 Million

BioXcel Therapeutics

BioXcel Therapeutics Provides an Update on its Ongoing Phase 3 SERENITY Trials

Sage Therapeutics

Sage to run 3 new studies to save once-failed depression drug

Adial Pharmaceuticals

Adial Pharmaceuticals Announces Modifications to the Phase 3 Pivotal Trial

Sage Therapeutics

Sage rethinks SAGE-217 program after phase 3 failure

Intra-Cellular Therapies

Pivotal Study of CAPLYTA™ (lumateperone) for the Treatment of Schizophrenia in Adults Published in JAMA Psychiatry

Adamis Pharmaceuticals

Adamis Pharmaceuticals Provides Update Regarding ZIMHI

BioXcel Therapeutics

BioXcel Therapeutics Initiates Phase 2 Study Designed to Assess Agitation-Associated Biomarkers and their Response to BXCL501

Biohaven Pharmaceuticals

Biohaven anxiety treatment fails late-stage study, shares fall 16%