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

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            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.

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            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®).

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            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.

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            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.

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            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.

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            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.

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            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.

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            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.

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            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).

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            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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