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[{"orgOrder":0,"company":"Vallon Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vallon Pharmaceuticals Presents Positive Data from Pilot Intranasal Human Abuse Study of Its Investigational Abuse Deterrent Stimulant, ADAIR, at the American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase I"},{"orgOrder":0,"company":"Vallon Pharmaceuticals","sponsor":"Undisclosed","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"CNS Pharmaceutical Developer Vallon Pharmaceuticals Files for a $17 million IPO","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase I"},{"orgOrder":0,"company":"Vallon Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vallon Pharmaceuticals Presents Positive Data from Proof-of-Concept Intranasal Human Abuse Study of Its Investigational ADHD Stimulant","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase I"},{"orgOrder":0,"company":"Vallon Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vallon Pharmaceuticals Continues Advancement of Pivotal Study in Lead Development Program, ADAIR, Toward Potential Approval","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase I"},{"orgOrder":0,"company":"Vallon Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vallon Pharmaceuticals Announces Topline Results of its Pivotal SEAL Study for Lead Program, ADAIR, for the Treatment of ADHD","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase I"},{"orgOrder":0,"company":"Vallon Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vallon Pharmaceuticals Reports Additional Pharmacokinetic and Pharmacodynamic Data from SEAL Study of ADAIR","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase I"},{"orgOrder":0,"company":"Vallon Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vallon Pharmaceuticals Announces Issuance of Japanese Patent Covering Composition of Matter and Methods of Manufacturing for ADAIR","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase I"},{"orgOrder":0,"company":"Vallon Pharmaceuticals","sponsor":"GRI Bio","pharmaFlowCategory":"D","amount":"$25.0 million","upfrontCash":"$15.0 million","newsHeadline":"Vallon Pharmaceuticals and GRI Bio Enter into Merger Agreement with Goal of Advancing Innovative Pipeline of NKT Cell Regulators","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"Vallon Pharmaceuticals","sponsor":"GRI Bio","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Vallon Pharmaceuticals Completes Merger with GRI Bio, Inc.","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase I"}]

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            Development Status

            Details:

            The combined company will advance innovative pipeline of Natural Killer T modulating therapies for the treatment of inflammatory, fibrotic and autoimmune diseases, including GRI-0621, an inhibitor of type 1 NKT cells.

            Lead Product(s): GRI-0621

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: GRI-0621

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: GRI Bio

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Merger April 21, 2023

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            Details:

            GRI-0621 is a small molecule RAR-βɣ dual agonist that inhibits the activity of human NKT I cells. In in vitro studies and after 28 days dosing in the study GRI-0621-201, oral dosing of GRI-0621 has been shown to inhibit NKT I cells in patients.

            Lead Product(s): GRI-0621

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: GRI-0621

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: GRI Bio

            Deal Size: $25.0 million Upfront Cash: $15.0 million

            Deal Type: Merger December 13, 2022

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            Details:

            Pharmacokinetic analysis showed that ADAIR (dextroamphetamine) intranasally demonstrated blunted pharmacokinetic profile compared to crushed and snorted dextroamphetamine including Cmax,Tmax, and AUC, especially during early time points up to 1, 2, and 4 hours after dosing.

            Lead Product(s): Amphetamine

            Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 12, 2022

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            ADAIR (dextroamphetamine), investigational new drug; a novel, patented formulation designed to deter attempts to crush and snort it or take it by other non-oral routes that can produce a greater “high".

            Lead Product(s): Amphetamine

            Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 11, 2022

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            Study did not meet primary endpoint of significant reduction in Emax Drug Liking for ADAIR (dextroamphetamine) vs reference dextroamphetamine, although a trend in favor of ADAIR was observed (p=0.16).

            Lead Product(s): Amphetamine

            Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 21, 2022

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            Details:

            ADAIR (Abuse Deterrent Amphetamine Immediate Release) is an investigational new drug; a novel, patented formulation of dextroamphetamine designed to deter attempts to crush and snort it or take it by other non-oral routes that can produce a greater “high.”

            Lead Product(s): Amphetamine

            Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 13, 2021

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            Details:

            Results demonstrated that ADAIR had slower absorption and lower early exposure, and was less desirable to recreational drug abusers on key measures of abuse liability compared to commercially available dextroamphetamine.

            Lead Product(s): Amphetamine

            Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 09, 2020

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            Details:

            The company's clinical-stage product currently under development is Abuse-Deterrent Amphetamine Immediate-Release, or ADAIR. ADAIR has completed a Phase 1 pivotal bioequivalence study and a Phase 1 food effect study.

            Lead Product(s): Amphetamine

            Therapeutic Area: Psychiatry/Psychology Product Name: ADAIR

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Public Offering October 23, 2020

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            Company to begin enrolling phase 1 clinical trial for first immune tolerance product, KAN-101, in first quarter of 2020.

            Lead Product(s): Amphetamine

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 21, 2020

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