X
[{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Marinus Pharmaceuticals Completes Targeted Enrollment in Pivotal Phase 3 Study for CDKL5 Deficiency Disorder","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Cowen","pharmaFlowCategory":"D","amount":"$40.0 million","upfrontCash":"Undisclosed","newsHeadline":"Marinus Pharmaceuticals Announces Proposed Public Offering of Common Stock","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Marinus Pharmaceuticals Provides Pipeline Update","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase II"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Marinus Pharmaceuticals Receives Rare Pediatric Disease Designation from FDA for Ganaxolone for the Treatment of CDKL5 Deficiency Disorder","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Marinus Provides Corporate Update on Phase 3 RAISE Trial in Status Epilepticus (SE)","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","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 Four Presentations on Ganaxolone at AES2020 Virtual Annual Meeting","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","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 Launches Expanded Access Program for Ganaxolone Treatment in CDKL5 Deficiency Disorder","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Marinus Gets Positive Response from FDA on Sufficiency of One Phase 3 Trial for Filing of NDA for the Use of Ganaxolone in CDD","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"BARDA","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Marinus Enrolls First Patient in Pivotal Phase 3 Clinical Trial of IV Ganaxolone in Refractory Status Epilepticus","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Orion Corporation","pharmaFlowCategory":"D","amount":"$145.0 million","upfrontCash":"$30.0 million","newsHeadline":"Marinus Pharmaceuticals Announces Exclusive Collaboration with Orion Corporation for European Commercialization of Ganaxolone","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Marinus Reports Topline Ganaxolone Phase 2 Results in Tuberous Sclerosis Complex and Receives FDA Orphan Drug Designation","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Marinus Pharmaceuticals Submits NDA for Ganaxolone for the Treatment of Seizures Associated with CDKL5 Deficiency Disorder","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Marinus Pharmaceuticals Provides Strategic Update at Virtual R&D Event","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not 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 molecule","productStatus":"New Molecular Entity","date":"May 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 Expands Enrollment Criteria to Support Recruitment in Phase 3 RAISE Trial in Refractory Status Epilepticus","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 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 U.S. Commercial Launch of ZTALMY\u00ae (ganaxolone) for Seizures Associated With CDKL5 Deficiency Disorder","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Novo Nordisk","pharmaFlowCategory":"D","amount":"$110.0 million","upfrontCash":"Undisclosed","newsHeadline":"Marinus Pharmaceuticals Sells Rare Pediatric Disease Priority Review Voucher for $110 Million","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Novo Nordisk","pharmaFlowCategory":"D","amount":"$110.0 million","upfrontCash":"$92.3 million","newsHeadline":"Marinus Pharmaceuticals Announces Closing of Sale of Priority Review Voucher for $110 Million","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Sagard Healthcare Partners","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"$32.5 million","newsHeadline":"Marinus Pharmaceuticals Announces $32.5 Million Revenue Interest Financing Agreement with Sagard Healthcare Partners","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"SVB Securities","pharmaFlowCategory":"D","amount":"$60.0 million","upfrontCash":"Undisclosed","newsHeadline":"Marinus Pharmaceuticals Announces Pricing of $60 Million Public Offering","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Tenacia Biotechnology","pharmaFlowCategory":"D","amount":"$266.0 million","upfrontCash":"$10.0 million","newsHeadline":"Marinus Pharmaceuticals Announces Collaboration with Tenacia Biotechnology for Ganaxolone Development and Commercialization in China","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Marinus Pharmaceuticals Receives FDA Orphan Drug Designation for Ganaxolone in the Treatment of Lennox-Gastaut Syndrome","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Preclinical"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Marinus Pharmaceuticals Receives Positive CHMP Opinion for ZTALMY\u00ae (ganaxolone) for the Adjunctive Treatment of Seizures Associated With CDKL5 Deficiency Disorder","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Orion 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"},{"orgOrder":0,"company":"Marinus Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Marinus Pharmaceuticals Provides Update on the Phase 3 RAISE Trial and Reports Preliminary First Quarter 2024 Financial Results","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals by Marinus Pharmaceuticals
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Companies By Therapeutic Area
Details:
Ztalmy (ganaxolone) is a neuroactive steroid that works by modulating both synaptic and extrasynaptic GABAA receptors via a unique binding site to potentiate two types of inhibitory signaling. It is being evaluated for the treatment of refractory status epilepticus.
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
April 15, 2024
Details:
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
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
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 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
Details:
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
Details:
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
Details:
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
Details:
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
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
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