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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 IIIProduct 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: ApprovedProduct 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: ApprovedProduct 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: PreclinicalProduct 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: ApprovedProduct 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: ApprovedProduct 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: ApprovedProduct 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 IIIProduct 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: ApprovedProduct 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: ApprovedProduct 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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