Psychiatry/Psychology | Phase II Developments | UNITED STATES

Embera NeuroTherapeutics

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Embera NeuroTherapeutics Announces First Subject Dosed in Phase 2 Study of EMB-001 in Cocaine Use Disorder

Lead Product(s): Metyrapone,Oxazepam

Therapeutic Area: Psychiatry/Psychology Product Name: EMB-001

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 August 31, 2020

Details:

The randomized, double-blind, placebo-controlled Phase 2 clinical trial is supported by funding from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health and will evaluate EMB-001 as a treatment option for patients with cocaine use disorder.

American BriVision

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American BriVision Announces New Patent Filed for Treatment of Major Depressive Disorder

Lead Product(s): PDC-1421

Therapeutic Area: Psychiatry/Psychology Product Name: ABV-1504

Highest Development Status: Phase II Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 24, 2020

Details:

The patent application outlines a method for treating major depressive disorder by the patient’s oral administration of a composition containing Radix Polygalae (Polygala tenuifolia Willd) extract (PDC-1421).

Newron Pharmaceuticals

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Newron Pharmaceuticals Provides Clinical and Business Update

Lead Product(s): Evenamide

Therapeutic Area: Psychiatry/Psychology Product Name: NW-3509

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 August 11, 2020

Details:

All evenamide pre-clinical studies requested by FDA completed and first clinical safety study initiated; on track to initiate evenamide Phase III program in 2021.

Medicinova

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MediciNova Announces the Presentation of Positive Results from Phase 2 Trial of MN‑166 (ibudilast) in Alcohol Use Disorder

Lead Product(s): Ibudilast

Therapeutic Area: Psychiatry/Psychology Product Name: MN-166

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: UCLA

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 06, 2020

Details:

This study was a randomized, double-blind, placebo-controlled Phase 2 trial to evaluate the effect of 14 days of ibudilast treatment on heavy drinking days and alcohol neural cue reactivity.

Achieve Life Sciences

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Achieve Life Sciences Announces Pricing of $6.5 Million Public Offering

Lead Product(s): Cytisinicline

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Lake Street Capital Markets

Deal Size: $6.5 million Upfront Cash: Undisclosed

Deal Type: Public Offering August 04, 2020

Details:

Achieve intends to use the proceeds from the offering to fund clinical research and development, and for general working capital.

Praxis Precision Medicines

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Praxis Precision Medicines Announces $110 Million Financing

Lead Product(s): PRAX-114

Therapeutic Area: Psychiatry/Psychology Product Name: PRAX-114

Highest Development Status: Phase II Product Type: Undisclosed

Partner/Sponsor/Collaborator: Eventide Asset Management

Deal Size: $110.0 million Upfront Cash: Undisclosed

Deal Type: Series C Financing July 28, 2020

Details:

Praxis' pipeline consists of PRAX-114, now under Phase 2 development for the treatment of major depressive disorder and perimenopausal depression; PRAX-944, under Phase 2 for essential tremor; and PRAX-562, in Phase 1 for pediatric epilepsy and adult cephalgia.

American BriVision

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American BriVision Reports Completion of ABV-1505 Phase II Part I Clinical Trial for Treatment of Adult ADHD

Lead Product(s): PDC-1421

Therapeutic Area: Psychiatry/Psychology Product Name: ABV-1505

Highest Development Status: Phase II Product Type: Undisclosed

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 28, 2020

Details:

Last patient last visit (LPLV) marked the final step toward the completion of ABV-1505 Phase II Part I clinical trial in treatment of adult attention-deficit hyperactivity disorder (ADHD).

Reviva Pharmaceuticals

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Tenzing Acquisition and Reviva Pharmaceuticals Announce Execution of Definitive Agreement and Plan of Merger

Lead Product(s): Brilaroxazine

Therapeutic Area: Psychiatry/Psychology Product Name: RP5063

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Tenzing

Deal Size: $119.0 million Upfront Cash: Undisclosed

Deal Type: Merger July 21, 2020

Details:

The acquisition adds Reviva's lead product candidate, RP5063 (brilaroxazine), for the treatment of schizophrenia, bipolar disorder, and major depressive disorder, to Tenzing's Pipeline.

Relmada Therapeutics

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Relmada Therapeutics Announces Notice of Allowance for Patent in Canada Covering REL-1017 for Treatment of Psychiatric Symptoms

Lead Product(s): Dextromethadone

Therapeutic Area: Psychiatry/Psychology Product Name: REL-1017

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 23, 2020

Details:

The patent that will issue from this allowed application provides broad coverage in Canada for REL-1017 (d-methadone, dextromethadone,) for the treatment of symptoms associated with a wide range of psychological and psychiatric disorders.

American BriVision

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American BriVision Announces Completed Patient Enrollment in Clinical Trial at UCSF for Treatment of Adult ADHD

Lead Product(s): PDC-1421

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Undisclosed

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 15, 2020

Details:

Patient enrollment has been completed for a Phase II Part I clinical trial at the University of California. Primary objective of clinical trial is to determine the effective dosage of ABV-1505 in treatment of adult attention-deficit hyperactivity disorder (ADHD).

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Embera NeuroTherapeutics

Embera NeuroTherapeutics Announces First Subject Dosed in Phase 2 Study of EMB-001 in Cocaine Use Disorder

American BriVision

American BriVision Announces New Patent Filed for Treatment of Major Depressive Disorder

Newron Pharmaceuticals

Newron Pharmaceuticals Provides Clinical and Business Update

Medicinova

MediciNova Announces the Presentation of Positive Results from Phase 2 Trial of MN‑166 (ibudilast) in Alcohol Use Disorder

Achieve Life Sciences

Achieve Life Sciences Announces Pricing of $6.5 Million Public Offering

Praxis Precision Medicines

Praxis Precision Medicines Announces $110 Million Financing

American BriVision

American BriVision Reports Completion of ABV-1505 Phase II Part I Clinical Trial for Treatment of Adult ADHD

Reviva Pharmaceuticals

Tenzing Acquisition and Reviva Pharmaceuticals Announce Execution of Definitive Agreement and Plan of Merger

Relmada Therapeutics

Relmada Therapeutics Announces Notice of Allowance for Patent in Canada Covering REL-1017 for Treatment of Psychiatric Symptoms

American BriVision

American BriVision Announces Completed Patient Enrollment in Clinical Trial at UCSF for Treatment of Adult ADHD