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Details:
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 IIIProduct 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
Details:
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 IIIProduct 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
Details:
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 IIIProduct 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
Details:
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 IIIProduct 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
Details:
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 IIIProduct 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
Details:
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2023
Details:
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2023
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 22, 2023
Details:
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 04, 2023
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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cingulate Therapeutics, LLC
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement March 13, 2023
Details:
CTx-1301 (dexmethylphenidate) is 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 IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 23, 2023
Details:
CTx-1301 (Dexmethylphenidate), utilizes proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of dexmethylphenidate (approved for ADHD treatment). Dexmethylphenidate is a stimulant which increases brain's norepinephrine and dopamine activity.
Lead Product(s): Dexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: CTx-1301
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2023
Details:
CTx-1301, utilizes the Company’s proprietary PTR™ drug delivery platform to create a breakthrough, multi-core formulation of the API dexmethylphenidate, a compound approved by the U.S. Food and Drug Administration (FDA) for the treatment of ADHD.
Lead Product(s): Dexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: CTx-1301
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2022
Details:
Under the agreement, Societal CDMO will manufacture all clinical, registration, and commercial batches of Cingulate’s lead candidate CTx-1301 (dexmethylphenidate), an investigational medication for the treatment of Attention Deficit / Hyperactivity Disorder (ADHD).
Lead Product(s): Dexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: CTx-1301
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cingulate Therapeutics, LLC
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 24, 2022
Details:
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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2022
Details:
AZSTARYS is the first and only medicine containing SDX, a prodrug of d-MPH, which provides for an extended duration of d-MPH release throughout the day. Once-daily AZSTARYS is available nationally in the U.S. in three SDX/immediate-release d-MPH dose strengths.
Lead Product(s): Serdexmethylphenidate,Dexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: Azstarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gurnet Point Capital
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2022
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: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 23, 2022
Details:
Company plans to initiate its CTx-1301 Phase 3 clinical studies: a fixed-dose pediatric and adolescent safety and efficacy study, a dose-optimization study extension, and a pediatric safety and efficacy study to assess the onset and duration of efficacy.
Lead Product(s): Dexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: CTx-1301
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 08, 2022
Details:
Cingulate intends to use the net proceeds of the offering for continued research and development and pre-commercialization planning of CTx-1301, continued research and development of CTx-1302, proof of concept study for CTx-2103, to satisfy obligations.
Lead Product(s): Dexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: CTx-1301
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Aegis Capital Corp.
Deal Size: $25.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering December 07, 2021
Details:
AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) significantly improved attention deficit hyperactivity disorder (ADHD) symptoms.
Lead Product(s): Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: Azstarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 29, 2021
Details:
AZSTARYS is a once-daily product for the treatment of ADHD in patients aged six years and older consisting of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH.
Lead Product(s): Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: Azstarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2021
Details:
The financing will provide funds to support continued U.S. commercialization of AZSTARYS which is used for the treatment of ADHD for patients 6 years of age and over that was approved by the FDA.
Lead Product(s): Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: Azstarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Hercules Capital
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing September 27, 2021
Details:
AZSTARYS is the first and only product containing a dexmethylphenidate (d-MPH) oral prodrug for the treatment of attention deficit hyperactivity disorder (ADHD) symptoms in patients aged six years and older.
Lead Product(s): Dexmethylphenidate,Serdexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: Azstarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2021
Details:
The License Agreement provides for an exclusive worldwide license to develop, manufacture and commercialize KemPharm’s product candidates containing serdexmethylphenidate and d-methylphenidate (d-MPH), including AZSTARYS.
Lead Product(s): Serdexmethylphenidate,Dexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: Azstarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Commave Therapeutics
Deal Size: $590.0 million Upfront Cash: Undisclosed
Deal Type: Collaboration April 21, 2021
Details:
Gurnet Point Capital affiliate gets exclusive worldwide license to develop, manufacture and commercialize KemPharm’s product candidates containing serdexmethylphenidate (SDX) and d-methylphenidate (d-MPH), including AZSTARYS for the treatment of ADHD.
Lead Product(s): Serdexmethylphenidate,Dexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: Azstarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gurnet Point Capital
Deal Size: $590.0 million Upfront Cash: $10.0 million
Deal Type: Licensing Agreement April 08, 2021
Details:
AZSTARYS contains 30 percent immediate-release d-MPH and 70 percent extended-release novel SDX, a prodrug of d-MPH. After absorption via the gastrointestinal tract, SDX is converted to d-MPH with a design to gradually release d-MPH throughout the day.
Lead Product(s): Serdexmethylphenidate,Dexmethylphenidate
Therapeutic Area: Psychiatry/Psychology Product Name: Azstarys
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2021
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