Minakem Generic APIs Minakem Generic APIs

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[{"orgOrder":0,"company":"KemPharm","sponsor":"Corium","pharmaFlowCategory":"D","amount":"$5.0 million","upfrontCash":"Not Applicable","newsHeadline":"KemPharm Eligible to Receive $5 Million Milestone Payment from Gurnet Point Capital After NDA Filing for Potential New ADHD Treatment","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"KemPharm","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"KemPharm Announces Issuance of Two Additional U.S. Patents Governing KP415 and KP484","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 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AZSTARYS\u2122","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"KemPharm","sponsor":"Commave Therapeutics","pharmaFlowCategory":"D","amount":"$590.0 million","upfrontCash":"Undisclosed","newsHeadline":"KemPharm Receives $10M Milestone Payment for FDA Approval of AZSTARYS Per License Agreement with Affiliate of Gurnet Point Capital","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"KemPharm","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"KemPharm Files IND for KP879 for the Treatment of Stimulant Use Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Corium","sponsor":"Hercules Capital","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Corium Secures $235 Million in Debt Financing","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"KemPharm","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"KemPharm Receives FDA Clearance to Initiate KP879 Clinical Program for the Treatment of Stimulant Use Disorder","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Corium","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. FDA Approves Novel Once-Daily Capsule AZSTARYS","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"IQVIA","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"IQVIA\u2019s Orchestrated Customer Engagement (OCE) Solution Chosen to Support the Commercial Launch of Novel ADHD Drug","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"KemPharm","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AZSTARYS\u00ae, An Innovative ADHD Treatment Developed by KemPharm, to be Featured in a Poster Presentation at the 2021 Psych Congress","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Corium","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Significant ADHD Symptom Improvement with 30-Minute Onset and 13-Hour Duration of Efficacy Delivered by Once-Daily Corium Product AZSTARYS\u00ae (Serdexmethylphenidate and Dexmethylphenidate) in Children Ages 6 to 12 Years","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"KemPharm","sponsor":"Hypersomnia Foundation","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"KemPharm Partners with the Hypersomnia Foundation to Support Sleep Disorder Research and Advocacy","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Sleep","graph2":"Phase II"},{"orgOrder":0,"company":"Zevra Therapeutics","sponsor":"RARE-X","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Zevra Therapeutics Announces Collaboration with RARE-X and the Sleep Consortium as Founding Member of New Sleep Data Initiative","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Sleep","graph2":"Phase II"},{"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":"Sleep","graph2":"Phase I"},{"orgOrder":0,"company":"Corium","sponsor":"Gurnet Point Capital","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Corium To Present at Academy of Managed Care Pharmacy: Fast-Acting AZSTARYS\u00ae (serdexmethylphenidate and dexmethylphenidate) Significantly Improves Attention and Behavior in Children Aged 6 to 12 Years With ADHD","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"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":"Sleep","graph2":"Phase I"},{"orgOrder":0,"company":"Corium","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Corium to Present Positive Data on ADHD Medication AZSTARYS\u00ae (serdexmethylphenidate and dexmethylphenidate) and Alzheimer's Disease Medication ADLARITY\u00ae (donepezil transdermal system) at Psych Congress 2022","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"KemPharm","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not 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Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zevra Therapeutics Announces Submission of IND for KP1077 in Narcolepsy","therapeuticArea":"Sleep","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Sleep","graph2":"IND Enabling"},{"orgOrder":0,"company":"Zevra Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zevra Therapeutics Announces FDA Acceptance of IND Application for KP1077 in Narcolepsy","therapeuticArea":"Sleep","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Sleep","graph2":"IND Enabling"},{"orgOrder":0,"company":"Corium","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Corium's Novel ADHD Medication AZSTARYS\u00ae (Serdexmethylphenidate and Dexmethylphenidate) Had No Clinically Significant Impact on Children's Weight and Height Growth Rate","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Zevra Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zevra Therapeutics Announces Interim Data from the Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Sleep","graph2":"Phase II"},{"orgOrder":0,"company":"Zevra Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zevra Therapeutics Announces Top-Line Data from the Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Sleep","graph2":"Phase II"}]

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            Details:

            KP1077 (serdexmethylphenidate) is a prodrug of d-methylphenidate, which acts as dopamine & norepinephrine transporter antagonists. It is being evaluated for the treatment of idiopathic hypersomnia.

            Lead Product(s): Serdexmethylphenidate

            Therapeutic Area: Sleep Product Name: KP1077

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 26, 2024

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            KP1077 is being developed as a treatment for idiopathic hypersomnia (IH) and narcolepsy. KP1077 is comprised solely of serdexmethylphenidate (SDX), KemPharm’s proprietary prodrug of d-methylphenidate.

            Lead Product(s): Serdexmethylphenidate

            Therapeutic Area: Sleep Product Name: KP1077

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 02, 2023

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            Azstarys (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) showed no clinically significant impact on weight and height growth rate in pediatric patients. CNS stimulants prescribed for treatment of ADHD have been associated with height and weight growth.

            Lead Product(s): Serdexmethylphenidate,Dexmethylphenidate

            Therapeutic Area: Psychiatry/Psychology Product Name: Azstarys

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 22, 2023

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            KP1077 is being developed as a treatment for idiopathic hypersomnia (IH) and narcolepsy. KP1077 is comprised solely of serdexmethylphenidate (SDX), KemPharm’s proprietary prodrug of d-methylphenidate.

            Lead Product(s): Serdexmethylphenidate

            Therapeutic Area: Sleep Product Name: KP1077

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 03, 2023

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            KP1077 is Zevra’s lead clinical candidate being developed to treat idiopathic hypersomnia (“IH”) and narcolepsy. KP1077 is comprised solely of serdexmethylphenidate (“SDX”), Zevra’s proprietary prodrug of d-methylphenidate (“d-MPH”).

            Lead Product(s): Serdexmethylphenidate

            Therapeutic Area: Sleep Product Name: KP1077

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 04, 2023

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            Details:

            The data being generated by Zevra's program for KP1077 (serdexmethylphenidate), a novel therapy for the treatment of IH, will support the research and development of effective treatments for rare sleep disorders through the use of new data collection platform led by RARE-X.

            Lead Product(s): Serdexmethylphenidate

            Therapeutic Area: Sleep Product Name: KP1077

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: RARE-X

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration March 17, 2023

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            KP1077 is KemPharm’s lead clinical candidate being developed as a treatment for idiopathic hypersomnia (IH) and narcolepsy. KP1077 is comprised solely of serdexmethylphenidate (SDX), KemPharm’s proprietary prodrug of d-methylphenidate.

            Lead Product(s): Serdexmethylphenidate

            Therapeutic Area: Sleep Product Name: KP1077

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Hypersomnia Foundation

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership January 18, 2023

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            Serdexmethylphenidate (SDX) is KemPharm’s proprietary prodrug of d-methylphenidate (d-MPH) and the sole active pharmaceutical ingredient (API) in KP1077, KemPharm’s lead clinical candidate being developed as a treatment for idiopathic hypersomnia (IH) and narcolepsy.

            Lead Product(s): Serdexmethylphenidate

            Therapeutic Area: Sleep Product Name: KP1077

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 21, 2022

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            SDX is the sole active pharmaceutical ingredient (API) in KP1077, KemPharm’s lead clinical candidate being developed as a treatment for IH and narcolepsy.

            Lead Product(s): Serdexmethylphenidate

            Therapeutic Area: Sleep Product Name: KP1077

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 18, 2022

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            AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) for patients six and older with ADHD, and ADLARITY (donepezil transdermal system) for patients with mild, moderate, or severe dementia of the Alzheimer's type.

            Lead Product(s): Serdexmethylphenidate,Dexmethylphenidate

            Therapeutic Area: Psychiatry/Psychology Product Name: Azstarys

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 13, 2022

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