Bora CDMO Bora CDMO

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[{"orgOrder":0,"company":"KemPharm","sponsor":"Gurnet Point Capital","pharmaFlowCategory":"D","amount":"$590.0 million","upfrontCash":"$10.0 million","newsHeadline":"KemPharm Announces Amendment to Licensing Agreement with Gurnet Point Capital Affiliate Following FDA Approval of 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":"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":"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":"Cingulate Therapeutics, LLC","sponsor":"Aegis Capital Corp.","pharmaFlowCategory":"D","amount":"$25.0 million","upfrontCash":"Undisclosed","newsHeadline":"Cingulate Inc. Announces Pricing of $25.0 Million Initial Public Offering","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase I\/ Phase II"},{"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":"Societal CDMO","sponsor":"Cingulate Therapeutics, LLC","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Cingulate Announces Agreement with Societal CDMO and Provides Clinical Update","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"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":"Indegene","sponsor":"Cingulate Therapeutics, LLC","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Cingulate and Indegene Announce Joint Commercialization Agreement for Lead ADHD Candidate CTx-1301","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Cingulate Therapeutics, LLC","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cingulate Provides 2022 Clinical Plan for CTx-1301, an Investigational Medication for Attention Deficit\/Hyperactivity Disorder (ADHD)","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase I\/ Phase II"},{"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":"Sleep","graph2":"Preclinical"},{"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":"Cingulate Therapeutics, LLC","sponsor":"H.C. 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Wainwright & Co.","pharmaFlowCategory":"D","amount":"$7.5 million","upfrontCash":"Undisclosed","newsHeadline":"Cingulate Announces Pricing of $7.5 Million Public Offering","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Cingulate Therapeutics, LLC","sponsor":"H.C. 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III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Cingulate Therapeutics, LLC","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cingulate Announces Positive Top-Line Results from Fed\/Fast Study of Lead Asset CTx-1301 for ADHD","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Cingulate Therapeutics, LLC","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cingulate Completes First Cohort of Phase 3 Adult Onset and Duration Trial of CTx-1301 (dexmethylphenidate) for ADHD","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"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":"Cingulate Therapeutics, LLC","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cingulate Completes Phase 3 Adult Trial of CTx-1301 (dexmethylphenidate) for ADHD","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Cingulate Therapeutics, LLC","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cingulate Successfully Manufactures Clinical Supply \u2013 Initiation of Pediatric Phase 3 Studies to Commence in July and August","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"},{"orgOrder":0,"company":"Cingulate Therapeutics, LLC","sponsor":"Dr. Vince Clinical Research","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dr. Vince Clinical Research Announces First Dosing in Cingulate Therapeutics\u2019 CTx-1301 Phase III Laboratory Classroom Study in ADHD Patients","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase III"}]

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            The Company intends to use the net proceeds for continued research and development and commercialization activities of its lead candidate CTx-1301 (dexmethylphenidate), a novel, investigational treatment being developed as a true, once-daily stimulant medication for ADHD.

            Lead Product(s): Dexmethylphenidate

            Therapeutic Area: Psychiatry/Psychology Product Name: CTx-1301

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

            Deal Size: $7.5 million Upfront Cash: Undisclosed

            Deal Type: Public Offering February 06, 2024

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            The Company intends to use the net proceeds for continued research and development and commercialization activities of its lead candidate CTx-1301 (dexmethylphenidate), a novel, investigational treatment being developed as a true, once-daily stimulant medication for ADHD.

            Lead Product(s): Dexmethylphenidate

            Therapeutic Area: Psychiatry/Psychology Product Name: CTx-1301

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

            Deal Size: $7.5 million Upfront Cash: Undisclosed

            Deal Type: Public Offering February 02, 2024

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            The Company intends to use the proceeds for continued research and development and commercialization activities of its lead candidate CTx-1301, a novel, trimodal formulation of dexmethylphenidate to treat ADHD.

            Lead Product(s): Dexmethylphenidate

            Therapeutic Area: Psychiatry/Psychology Product Name: CTx-1301

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

            Deal Size: $4.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering September 13, 2023

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            The proceeds will fund for continued R&D and commercialization activities of company's lead candidate CTx-1301 (dexmethylphenidate), a novel, investigational treatment being developed as a once-daily stimulant medication for attention-deficit/hyperactivity disorder.

            Lead Product(s): Dexmethylphenidate

            Therapeutic Area: Psychiatry/Psychology Product Name: CTx-1301

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

            Deal Size: $4.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering September 11, 2023

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            CTx-1301 (dexmethylphenidate) is a sustained release and immediate-release tablet part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior. It is being developed for ADHD.

            Lead Product(s): Dexmethylphenidate

            Therapeutic Area: Psychiatry/Psychology Product Name: CTx-1301

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Dr. Vince Clinical Research

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 06, 2023

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            CTx-1301 (dexmethylphenidate) is a sustained release and immediate-release tablet part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior. It is being developed for ADHD.

            Lead Product(s): Dexmethylphenidate

            Therapeutic Area: Psychiatry/Psychology Product Name: CTx-1301

            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 June 29, 2023

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            CTx-1301 (dexmethylphenidate) is a sustained release and immediate-release tablet part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior. It is being developed for ADHD.

            Lead Product(s): Dexmethylphenidate

            Therapeutic Area: Psychiatry/Psychology Product Name: CTx-1301

            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 June 08, 2023

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            Details:

            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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            CTx-1301, utilizes the Company’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD

            Lead Product(s): Dexmethylphenidate

            Therapeutic Area: Psychiatry/Psychology Product Name: CTx-1301

            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 April 04, 2023

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            Details:

            Under the agreement, Indegene will provide commercial support for Cingulate’s lead candidate CTx-1301 (dexmethylphenidate), a novel, investigational treatment being developed as a true, once-daily stimulant medication for attention deficit/hyperactivity disorder.

            Lead Product(s): Dexmethylphenidate

            Therapeutic Area: Psychiatry/Psychology Product Name: CTx-1301

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Cingulate Therapeutics, LLC

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement March 13, 2023

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