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

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            Lead Product(s): Ondansetron

            Therapeutic Area: Psychiatry/Psychology Product Name: AD04

            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 November 03, 2020

            Details:

            ONWARD is Testing Adial's lead drug candidate, AD04, as a therapeutic agent for the treatment of Alcohol Use Disorder in persons with certain target genotypes related to the serotonin transporter and receptor genes. 40% of expected Trial patient screenings have been completed.

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            Lead Product(s): Amphetamine Sulfate

            Therapeutic Area: Psychiatry/Psychology Product Name: TRN-110

            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 October 22, 2020

            Details:

            The new amphetamine extended-release tablet is an investigational agent and is not currently approved for use in any country.

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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 October 22, 2020

            Details:

            KP415 is KemPharm’s investigational product candidate for the treatment of attention deficit hyperactivity disorder (ADHD). Serdexmethylphenidate (SDX) is KemPharm’s prodrug of d-methylphenidate (d-MPH).

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            Lead Product(s): SAGE-217

            Therapeutic Area: Psychiatry/Psychology Product Name: SAGE-217

            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 October 15, 2020

            Details:

            For the primary endpoint of safety and tolerability, the data analyzed to date show that zuranolone was generally well-tolerated in the 30 mg dose and among the initial patients treated with the 50 mg dose.

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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 October 07, 2020

            Details:

            ORCA-2 participants will be randomized to one of three study arms to determine the smoking cessation efficacy and safety profile of cytisinicline administered for either 6 or 12 weeks, compared to placebo.

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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: Hercules Capital

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Financing September 29, 2020

            Details:

            The committed capital strengthens the Company’s balance sheet through the anticipated commercial launches of its two lead product candidates, AXS-05 for major depressive disorder and AXS-07 for migraine, and extends its cash runway, based on current operating plans.

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            Lead Product(s): Ondansetron

            Therapeutic Area: Psychiatry/Psychology Product Name: AD04

            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 25, 2020

            Details:

            Adial's lead drug candidate, AD04, is a therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in persons with certain target genotypes and the Company and regulatory advisors have concluded that AD04 is a candidate for this FDA program.

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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 18, 2020

            Details:

            The study, conducted at the University of Cambridge Department of Biochemistry by Professor Sarah Lummis and Dr. Kerry Price, was designed to examine the in vitro binding characteristics of cytisinicline compared to varenicline at the human 5-HT3 receptor.

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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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