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    [{"orgOrder":0,"company":"Orexia Therapeutics","sponsor":"Centessa Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Sosei Heptares Spin-Off Company Orexia Therapeutics Merged Into Newly Created Centessa Pharmaceuticals","therapeuticArea":"Sleep","highestDevelopmentStatus":"Preclinical","country":"","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Orexia Therapeutics"},{"orgOrder":0,"company":"Enalare Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Enalare Therapeutics Receives Rare Pediatric Disease Designation for Lead Compound ENA-001 for the Treatment of Apnea of Prematurity.","therapeuticArea":"Sleep","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Enalare Therapeutics"},{"orgOrder":0,"company":"KemPharm","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"KemPharm Completes KP1077 Pre-IND Meeting Process with FDA","therapeuticArea":"Sleep","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"KemPharm"},{"orgOrder":0,"company":"RespireRx Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"RespireRx Pharmaceuticals Inc. Announces Patent Filings Claiming Novel Lipid Based Formulations for Insoluble Compounds, Including Cannabinoids Such as Dronabinol","therapeuticArea":"Sleep","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"RespireRx Pharmaceuticals"},{"orgOrder":0,"company":"Tris Pharma Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Tris Pharma Announces Development of a Very Low Sodium and Once-Nightly Oxybate Formulation","therapeuticArea":"Sleep","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Tris Pharma Inc"},{"orgOrder":0,"company":"Eagle Pharmaceuticals","sponsor":"Enalare Therapeutics","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Eagle Pharmaceuticals and Enalare Therapeutics Announce FDA Orphan Drug Designation for ENA-001 for the Treatment of Apnea of Prematurity, a New Chemical Entity Being Developed as an Agnostic Respiratory Stimulant","therapeuticArea":"Sleep","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Eagle Pharmaceuticals"},{"orgOrder":0,"company":"Enalare Therapeutics","sponsor":"National Institutes of Health","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Enalare Therapeutics Receives Orphan Drug Designation From the U.S. FDA on ENA-001 for the Treatment of Apnea of Prematurity (AoP)","therapeuticArea":"Sleep","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Enalare Therapeutics"}]

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              Eagle Pharmaceuticals

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              Eagle Pharmaceuticals and Enalare Therapeutics Announce FDA Orphan Drug Designation for ENA-001 for the Treatment of Apnea of Prematurity, a New Chemical Entity Being Devel...

              Details:

              ENA-001, is a one-of-a-kind new chemical entity (NCE) designed as an agnostic respiratory stimulant. The compound has a novel mechanism of action that affects ventilation via the peripheral chemoreceptor pathways in the carotid body.

              Lead Product(s): ENA-001

              Therapeutic Area: Sleep Product Name: ENA-001

              Highest Development Status: Preclinical Product Type: Small molecule

              Partner/Sponsor/Collaborator: Enalare Therapeutics

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 03, 2022

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              Enalare Therapeutics

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              Enalare Therapeutics Receives Orphan Drug Designation From the U.S. FDA on ENA-001 for the Treatment of Apnea of Prematurity (AoP)

              Details:

              Enalare's lead compound, ENA-001, is a one-of-a-kind new chemical entity (NCE) designed as an agnostic respiratory stimulant. The compound has a novel mechanism of action that affects ventilation via the peripheral chemoreceptor pathways in the carotid body.

              Lead Product(s): ENA-001

              Therapeutic Area: Sleep Product Name: ENA-001

              Highest Development Status: Preclinical Product Type: Small molecule

              Partner/Sponsor/Collaborator: National Institutes of Health

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 03, 2022

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              Tris Pharma Inc

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              Tris Pharma Announces Development of a Very Low Sodium and Once-Nightly Oxybate Formulation

              Details:

              In a human clinical study, Tris established about 100% bioavailability for one dose of its formulation against two doses of XYREM at 4.5 gm each, equivalent to the 9.0 gm maximum dose of sodium oxybate.

              Lead Product(s): Gamma-Hydroxybutyric Acid Sodium

              Therapeutic Area: Sleep Product Name: Undisclosed

              Highest Development Status: Preclinical Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable July 27, 2022

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              RespireRx Pharmaceuticals

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              RespireRx Pharmaceuticals Inc. Announces Patent Filings Claiming Novel Lipid Based Formulations for Insoluble Compounds, Including Cannabinoids Such as Dronabinol

              Details:

              Provisional patent application describing novel lipid based formulation technology (LFT) that may be used to improve the solubility and bioavailability of poorly soluble drugs particularly cannabinoids Dronabinol that is formulated as a sesame oil emulsion.

              Lead Product(s): Tetrahydrocannabinol

              Therapeutic Area: Sleep Product Name: Undisclosed

              Highest Development Status: Preclinical Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 23, 2022

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              KemPharm

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              KemPharm Completes KP1077 Pre-IND Meeting Process with FDA

              Details:

              The successful completion of the pre-IND meeting process with the FDA for KP1077 affirms company's plan to submit the IND application by mid-year 2022 and to initiate a Phase 2 trial of KP1077 for Idiopathic Hypersomnia.

              Lead Product(s): Dexmethylphenidate

              Therapeutic Area: Sleep Product Name: KP1077

              Highest Development Status: Preclinical Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 23, 2022

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              Enalare Therapeutics

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              Enalare Therapeutics Receives Rare Pediatric Disease Designation for Lead Compound ENA-001 for the Treatment of Apnea of Prematurity.

              Details:

              Rare Pediatric Disease Designation received for ENA-001, a unique agnostic respiratory stimulant has the potential to significantly improve the standard of care for neonates experiencing life-threatening and debilitating respiratory conditions.

              Lead Product(s): ENA-001

              Therapeutic Area: Sleep Product Name: ENA-001

              Highest Development Status: Preclinical Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 14, 2021

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              Orexia Therapeutics

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              Sosei Heptares Spin-Off Company Orexia Therapeutics Merged Into Newly Created Centessa Pharmaceuticals

              Details:

              Orexia Therapeutics has been merged into Centessa. Orexia is developing oral and intranasal orexin receptor agonists using structure-based drug design approaches.

              Lead Product(s): Undisclosed

              Therapeutic Area: Sleep Product Name: Undisclosed

              Highest Development Status: Preclinical Product Type: Small molecule

              Partner/Sponsor/Collaborator: Centessa Pharmaceuticals

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Merger February 16, 2021

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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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