Psychiatry/Psychology | Phase III Developments | UNITED STATES

Arbor Pharmaceuticals

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Arbor Presents Data from Pivotal Study of AR19 to Resist Physical Manipulation form Nonmedical Misuse or Abuse

Lead Product(s): Amphetamine Sulfate

Therapeutic Area: Psychiatry/Psychology Product Name: AR19

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 September 10, 2020

Details:

The Phase 3 data being presented support Arbor’s New Drug Application (NDA) for AR19, which also includes data demonstrating that AR19 resists manipulation for nonmedical misuse and abuse by non-oral routes of administration.

Achieve Life Sciences

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Achieve Life Sciences Announces Presentation of Cytisinicline Data at the 20th Annual SRNT-E Virtual Conference

Lead Product(s): Cytisinicline

Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

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 September 10, 2020

Details:

Cytisinicline data will be featured in two presentations on Friday, September 18th, at the SRNT-E virtual conference. Both presentations evaluate positive findings from studies comparing cytisinicline to varenicline (Chantix®).

Intra-Cellular Therapies

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Intra-Cellular Therapies Announces Positive Results from Study 402 Evaluating Lumateperone as Adjunctive Therapy for Bipolar Depression

Lead Product(s): Lumateperone

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 September 09, 2020

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.

Axsome Therapeutics

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Axsome Therapeutics Announces Further Progress in AXS-05 Depression Clinical Program

Lead Product(s): Dextromethorphan,Bupropion

Therapeutic Area: Psychiatry/Psychology Product Name: AXS-05

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 August 10, 2020

Details:

Enrollment has been completed in the COMET (Clinical Outcomes with NMDA-based Depression Treatment) Phase 3 open-label, long-term safety trial to support the planned NDA filing of AXS-05 in MDD.

VistaGen Therapeutics

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VistaGen Therapeutics Announces Closing of $12.5 Million Underwritten Public Offering

Lead Product(s): PH94B

Therapeutic Area: Psychiatry/Psychology Product Name: PH94B

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Maxim Group LLC

Deal Size: $12.5 million Upfront Cash: Undisclosed

Deal Type: Public Offering August 05, 2020

Details:

VistaGen currently intends to use the net proceeds from the offering for the continued development of its CNS pipeline programs, general research and development, working capital and general corporate purposes.

VistaGen Therapeutics

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VistaGen Therapeutics Announces Receipt of $5 Million Non-Dilutive Upfront License Payment from EverInsight Therapeutics for PH94B

Lead Product(s): PH94B

Therapeutic Area: Psychiatry/Psychology Product Name: PH94B

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: EverInsight Therapeutics

Deal Size: Undisclosed Upfront Cash: $5.0 million

Deal Type: Licensing Agreement August 04, 2020

Details:

EverInsight is responsible for clinical development, regulatory submissions and commercialization of PH94B, VistaGen's rapid-onset neuroactive nasal spray, for acute treatment of anxiety in adults with social anxiety disorder, in Greater China South Korea and Southeast Asia.

VistaGen Therapeutics

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VistaGen Therapeutics Announces Proposed Public Offering of Common Stock

Lead Product(s): PH94B

Therapeutic Area: Psychiatry/Psychology Product Name: PH94B

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Maxim Group LLC

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Public Offering July 31, 2020

Details:

VistaGen currently intends to use the net proceeds from the offering to fund continued development of its CNS pipeline programs, and for general research and development, working capital and general corporate purposes.

Acadia Pharmaceuticals

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Pimavanserin Reduces Dementia-Related Psychosis Symptoms

Lead Product(s): Pimavanserin

Therapeutic Area: Psychiatry/Psychology Product Name: Nuplazid

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 July 29, 2020

Details:

Treatment with pimavanserin (Nuplazid; Acadia Pharmaceuticals) produced a robust reduction in psychosis symptoms, irrespective of most likely clinical diagnosis of dementia subtype or baseline dementia severity.

KemPharm

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KemPharm Announces Issuance of Two Additional U.S. Patents Governing KP415 and KP484

Lead Product(s): Serdexmethylphenidate

Therapeutic Area: Psychiatry/Psychology Product Name: KP415

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 July 28, 2020

Details:

These newly-issued patents have an expiration date of December 9, 2037, which is an extension of approximately five years past the previously-issued patents generally describing compositions based on a prodrug of d-methylphenidate (serdexmethylphenidate or SDX).

VistaGen Therapeutics

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VistaGen Therapeutics Announces Positive Meeting with FDA Regarding Pivotal Phase 3 Study of PH94B for Acute Treatment of Anxiety

Lead Product(s): PH94B

Therapeutic Area: Psychiatry/Psychology Product Name: PH94B

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 July 23, 2020

Details:

VistaGen and the FDA reached consensus on key aspects of a unique initial pivotal Phase 3 clinical trial of PH94B involving a single-event, laboratory-simulated public speaking challenge in adult patients with SAD.

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Find Psychiatry/Psychology Drugs in Phase III Clinical Development in UNITED STATES

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Arbor Pharmaceuticals

Arbor Presents Data from Pivotal Study of AR19 to Resist Physical Manipulation form Nonmedical Misuse or Abuse

Achieve Life Sciences

Achieve Life Sciences Announces Presentation of Cytisinicline Data at the 20th Annual SRNT-E Virtual Conference

Intra-Cellular Therapies

Intra-Cellular Therapies Announces Positive Results from Study 402 Evaluating Lumateperone as Adjunctive Therapy for Bipolar Depression

Axsome Therapeutics

Axsome Therapeutics Announces Further Progress in AXS-05 Depression Clinical Program

VistaGen Therapeutics

VistaGen Therapeutics Announces Closing of $12.5 Million Underwritten Public Offering

VistaGen Therapeutics

VistaGen Therapeutics Announces Receipt of $5 Million Non-Dilutive Upfront License Payment from EverInsight Therapeutics for PH94B

VistaGen Therapeutics

VistaGen Therapeutics Announces Proposed Public Offering of Common Stock

Acadia Pharmaceuticals

Pimavanserin Reduces Dementia-Related Psychosis Symptoms

KemPharm

KemPharm Announces Issuance of Two Additional U.S. Patents Governing KP415 and KP484

VistaGen Therapeutics

VistaGen Therapeutics Announces Positive Meeting with FDA Regarding Pivotal Phase 3 Study of PH94B for Acute Treatment of Anxiety