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Find Clinical Drug Pipeline Developments & Deals by Marinus Pharmaceuticals

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            Lead Product(s): Ganaxolone

            Therapeutic Area: Neurology Product Name: CCD 1042

            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 September 24, 2020

            Details:

            Marinus Pharmaceuticals has satisfied the FDA’s protocol-specific questions for the registrational Phase 3 trial (the RAISE trial) in refractory status epilepticus (RSE), allowing the company to begin enrollment in this clinical trial.

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            Lead Product(s): Ganaxolone

            Therapeutic Area: Genetic Disease Product Name: CCD 1042

            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 July 30, 2020

            Details:

            U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation for the company’s product candidate ganaxolone for the treatment of CDKL5 deficiency disorder (CDD), a rare refractory form of pediatric epilepsy.

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            Lead Product(s): Ganaxolone

            Therapeutic Area: Neurology Product Name: Undisclosed

            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 June 30, 2020

            Details:

            Marinus has finalized the protocol for its planned Phase 3 pivotal clinical trial in SE following its End of Phase 2 Meeting held in March 2020 and based on the successful results from its completed Phase 2 trial.

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            Lead Product(s): Ganaxolone

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Cowen

            Deal Size: $40.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering May 28, 2020

            Details:

            Marinus intends to use the net proceeds to fund the development of its product candidates and working capital, capital expenditures, research and development expenditures, clinical trial expenditures, acquisitions of new technologies, products or businesses, and investments.

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            Lead Product(s): Ganaxolone

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            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 February 25, 2020

            Details:

            The Marigold Study is a pivotal Phase 3 study evaluating oral ganaxolone in children and young adults with CDKL5 Deficiency Disorder (CDD).