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    [{"orgOrder":0,"company":"Imbrium Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Imbrium Therapeutics Presents First Data and Describes Novel Mechanism of Action For IMB-115","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Imbrium Therapeutics"},{"orgOrder":0,"company":"XWPharma","sponsor":"Panacea Venture","pharmaFlowCategory":"D","amount":"$40.0 million","upfrontCash":"Undisclosed","newsHeadline":"XWPharma Announces $40 Million Financing and Appoints Leonard Blum as Chief Executive Officer","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"XWPharma"},{"orgOrder":0,"company":"KemPharm","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"KemPharm Announces Full Data Set from Higher-Dose Serdexmethylphenidate (SDX) Phase 1 Clinical Trial","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"KemPharm"},{"orgOrder":0,"company":"KemPharm","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"KemPharm Doses First Subject in Phase 1 Clinical Trial Evaluating Cardiovascular Safety of Serdexmethylphenidate (SDX)","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"KemPharm"},{"orgOrder":0,"company":"KemPharm","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"KemPharm Announces Submission of Investigational New Drug Application for Phase 2 Trial of KP1077 in Idiopathic Hypersomnia (IH)","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"KemPharm"},{"orgOrder":0,"company":"Incannex Healthcare","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Positive Pre-IND Meeting with US FDA for IHL-42X for Obstructive Sleep Apnoea","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase I","country":"AUSTRALIA","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Incannex Healthcare"},{"orgOrder":0,"company":"Sumitomo","sponsor":"Jazz Pharmaceuticals","pharmaFlowCategory":"D","amount":"$1,140.0 million","upfrontCash":"$50.0 million","newsHeadline":"Jazz Pharmaceuticals and Sumitomo Pharma Announce Exclusive License Agreement to Develop and Commercialize DSP-0187, a Potent, Highly Selective Oral Orexin-2 Receptor Agonist","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase I","country":"JAPAN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Sumitomo"},{"orgOrder":0,"company":"Fortrea","sponsor":"Incannex Healthcare","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Incannex Engages Fortrea to Manage its FDA IND Opening Phase 2\/3 Clinical Trial Investigating IHL-42X for Treatment of Obstructive Sleep Apnoea","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Fortrea"}]

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              Fortrea

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              Incannex Engages Fortrea to Manage its FDA IND Opening Phase 2/3 Clinical Trial Investigating IHL-42X for Treatment of Obstructive Sleep Apnoea

              Details:

              Fortrea will manage Incannex's IND opening Phase 2/3 clinical trial investigating IHL-42X which is a synergistic composition of dronabinol, a synthetic form of Tetrahydrocannabinol, and acetazolamide, a carbonic anhydrase inhibitor, for treatment of obstructive sleep apnoea.

              Lead Product(s): Acetazolamide,Tetrahydrocannabinol

              Therapeutic Area: Sleep Product Name: IHL-42X

              Highest Development Status: Phase I Product Type: Small molecule

              Partner/Sponsor/Collaborator: Incannex Healthcare

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Partnership July 18, 2023

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              Incannex Healthcare

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              Positive Pre-IND Meeting with US FDA for IHL-42X for Obstructive Sleep Apnoea

              Details:

              IHL-42X (dronabinol) is a fixed-dose combination of dronabinol and acetazolamide that is being developed as a treatment for obstructive sleep apnoea (‘OSA’) in adults.

              Lead Product(s): Tetrahydrocannabinol,Acetazolamide

              Therapeutic Area: Sleep Product Name: IHL-42X

              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 17, 2022

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              KemPharm

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              KemPharm Announces Submission of Investigational New Drug Application for Phase 2 Trial of KP1077 in Idiopathic Hypersomnia (IH)

              Details:

              The data suggest that KP1077 (serdexmethylphenidate) produces a smoother, more gradual release of d-MPH that may avoid the adverse events associated with large and rapid exposure fluctuations that may be experienced with other stimulant-based therapies.

              Lead Product(s): Serdexmethylphenidate

              Therapeutic Area: Sleep Product Name: KP1077

              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 05, 2022

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              Sumitomo

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              Jazz Pharmaceuticals and Sumitomo Pharma Announce Exclusive License Agreement to Develop and Commercialize DSP-0187, a Potent, Highly Selective Oral Orexin-2 Receptor Agoni...

              Details:

              Under the agreement, Jazz will receive an exclusive license to develop and commercialize narcolepsy and sleep drug DSP-0187/JZP441 in U.S., Europe and other territories except Japan, China and other Asia/Pacific countries and regions, where Sumitomo Pharma will retain rights.

              Lead Product(s): DSP-0187

              Therapeutic Area: Sleep Product Name: JZP441

              Highest Development Status: Phase I Product Type: Small molecule

              Partner/Sponsor/Collaborator: Jazz Pharmaceuticals

              Deal Size: $1,140.0 million Upfront Cash: $50.0 million

              Deal Type: Licensing Agreement May 04, 2022

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              KemPharm

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              KemPharm Doses First Subject in Phase 1 Clinical Trial Evaluating Cardiovascular Safety of Serdexmethylphenidate (SDX)

              Details:

              Prodrug of d-methylphenidate, is sole API in KP1077, a potential first-ever therapeutic treatment for Idiopathic Hypersomnia, a neurological disorder marked by significant, detrimental effects on nighttime sleep as well as daytime sleepiness/wakefulness.

              Lead Product(s): Methylphenidate

              Therapeutic Area: Sleep Product Name: KP1077

              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 19, 2022

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              KemPharm

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              KemPharm Announces Full Data Set from Higher-Dose Serdexmethylphenidate (SDX) Phase 1 Clinical Trial

              Details:

              Data demonstrate higher doses of KP1077 (serdexmethylphenidate) prodrug of d-methylphenidate, were generally well-tolerated and produced targeted pharmacodynamic effects that may be beneficial for the treatment of idiopathic hypersomnia and other sleep disorders.

              Lead Product(s): Serdexmethylphenidate

              Therapeutic Area: Sleep Product Name: KP1077

              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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              XWPharma

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              XWPharma Announces $40 Million Financing and Appoints Leonard Blum as Chief Executive Officer

              Details:

              XWPharma expects to use proceeds to advance clinical development of the company’s lead investigational programs: XW10172, a GABAB receptor agonist intended for the treatment of sleep disorders in narcolepsy, Parkinson’s disease and other neurodegenerative diseases.

              Lead Product(s): XW10172

              Therapeutic Area: Sleep Product Name: XW10172

              Highest Development Status: Phase I Product Type: Small molecule

              Partner/Sponsor/Collaborator: Panacea Venture

              Deal Size: $40.0 million Upfront Cash: Undisclosed

              Deal Type: Series C Financing September 17, 2020

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              Imbrium Therapeutics

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              Imbrium Therapeutics Presents First Data and Describes Novel Mechanism of Action For IMB-115

              Details:

              IMB-115 is a novel, highly potent and selective partial agonist for nociceptin/orphanin-FQ peptide (NOP) receptors designed to promote sleep onset and maintenance at doses that show minimal or no residual next-day somnolence (drowsiness) or psychomotor impairment.

              Lead Product(s): IMB-115

              Therapeutic Area: Sleep Product Name: IMB-115

              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 August 28, 2020

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              ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
              Douglas Pharma, a New Zealand success story, with CDMO capabilities for softgels, liquids, tablets, capsules & powders.
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