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Applicable","upfrontCash":"Not Applicable","newsHeadline":"Marinus Pharmaceuticals Announces Delay to RAISE Phase 3 Clinical Trial in Status Epilepticus and Associated IV Ganaxolone Clinical Trials","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Marinus Pharmaceuticals Announces FDA Approval of ZTALMY\u00ae (ganaxolone) for CDKL5 Deciency Disorder","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Approved"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Marinus Pharmaceuticals Announces Publication in The Lancet Neurology of ZTALMY\u00ae (ganaxolone) Phase 3 Marigold Trial Results","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Approved"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Marinus Pharmaceuticals Announces Resumption of Phase 3 RAISE Trial in Status Epilepticus","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small 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Corporation","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Commission Approval of Ztalmy (ganaxolone) for the Adjunctive Treatment of Epileptic Seizures Associated with CDKL5 Deficiency Disorder","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"}]

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            Ztalmy (ganaxolone) is a positive allosteric modulation of the gamma-aminobutyric acid type A (GABAA) receptor in the CNS. It is used for the treatment of epileptic seizures associated with CDKL5 deficiency disorder.

            Lead Product(s): Ganaxolone

            Therapeutic Area: Genetic Disease Product Name: Ztalmy

            Highest Development Status: Approved Product Type: Small molecule

            Recipient: Orion Corporation

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 31, 2023

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            Details:

            Ztalmy (ganaxolone) is a positive allosteric modulation of the gamma-aminobutyric acid type A (GABAA) receptor in the CNS. It is investigated for the treatment of Seizures Associated With CDKL5 Deficiency Disorder.

            Lead Product(s): Ganaxolone

            Therapeutic Area: Genetic Disease Product Name: Ztalmy

            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 26, 2023

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            Ztalmy (ganaxolone) is a positive allosteric modulation of the gamma-aminobutyric acid type A (GABAA) receptor in the CNS. It is investigated for the treatment of lennox-gastaut syndrome.

            Lead Product(s): Ganaxolone

            Therapeutic Area: Genetic Disease Product Name: Ztalmy

            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 22, 2023

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            Under the terms of the agreement, Tenacia will receive exclusive rights to develop and commercialize certain formulations of Ztalmy (ganaxolone) in Mainland China, Hong Kong, Macau and Taiwan, including the current oral and intravenous (IV) dose formulations.

            Lead Product(s): Ganaxolone

            Therapeutic Area: Neurology Product Name: Ztalmy

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Tenacia Biotechnology

            Deal Size: $266.0 million Upfront Cash: $10.0 million

            Deal Type: Collaboration November 17, 2022

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            Marinus intends to use the net proceeds of the offering to continue to fund commercialization of ZTALMY® (ganaxolone) oral suspension CV, the development of its product candidates and for general corporate purposes.

            Lead Product(s): Ganaxolone

            Therapeutic Area: Neurology Product Name: Ztalmy

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: SVB Securities

            Deal Size: $60.0 million Upfront Cash: Undisclosed

            Deal Type: Public Offering November 07, 2022

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            Under the terms of the revenue interest financing agreement, Sagard will provide Marinus with an upfront cash payment in exchange for tiered payments on annual U.S. net sales of ganaxolone, including ZTALMY (ganaxolone).

            Lead Product(s): Ganaxolone

            Therapeutic Area: Genetic Disease Product Name: Ztalmy

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Sagard Healthcare Partners

            Deal Size: Undisclosed Upfront Cash: $32.5 million

            Deal Type: Financing October 31, 2022

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            Marinus anticipates using the proceeds for the ZTALMY® (ganaxolone) commercial launch, execution of its Phase 3 clinical programs in refractory status epilepticus and tuberous sclerosis complex, and other general expenditures.

            Lead Product(s): Ganaxolone

            Therapeutic Area: Neurology Product Name: Ztalmy

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Novo Nordisk

            Deal Size: $110.0 million Upfront Cash: $92.3 million

            Deal Type: Agreement August 29, 2022

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            Details:

            ZTALMY® (ganaxolone) oral suspension CV is the first and only FDA-approved treatment indicated specifically for seizures associated with cyclin-dependent kinase-like 5 deficiency disorder (CDD) in patients two years of age and older.

            Lead Product(s): Ganaxolone

            Therapeutic Area: Genetic Disease Product Name: Ztalmy

            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 July 28, 2022

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            Details:

            Marinus was awarded the voucher when it received approval of ZTALMY® (ganaxolone) oral suspension CV for the treatment of seizures associated with CDKL5 deciency disorder, a rare form of genetic epilepsy.

            Lead Product(s): Ganaxolone

            Therapeutic Area: Neurology Product Name: Ztalmy

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Novo Nordisk

            Deal Size: $110.0 million Upfront Cash: Undisclosed

            Deal Type: Divestment July 14, 2022

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            Details:

            Ztalmy (Ganaxolone) is a neuroactive steroid GABAA receptor modulator that acts on a well-characterized target in the brain known to have anti-seizure effects.

            Lead Product(s): Ganaxolone

            Therapeutic Area: Neurology Product Name: Ztalmy

            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, 2022

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