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Marinus Files US Application For Ganaxolone For Genetic Epilepsy, Inks European Commercialization Pact With Orion

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  • Marinus Pharmaceuticals Inc (NASDAQ: MRNS) has submitted a marketing application to the FDA seeking approval for its lead product candidate, ganaxolone, to treat seizures associated with CDKL5 deficiency disorder (CDD).

  • An application filing notification letter from the FDA is expected before the end of Q3 2021.

  • If the application is accepted for filing by the FDA, the Company will be able to draw $30 million of additional cash under its credit financing agreement with Oaktree Capital Management.

  • The application is supported by Phase 3 trial data in which 101 patients treated with ganaxolone showed a 30.7% median reduction in 28-day major motor seizure frequency, compared to a 6.9% reduction on placebo.

  • The Company also said that due to COVID-19 related priorities, data readout from Ganaxolone Phase 3 RAISE trial is expected in 2H of 2022. The majority of the clinical sites are expected to open by the end of Q3 2021.

  • Separately, Orion Corporation received exclusive rights to commercialize ganaxolone oral and intravenous dose formulations in Europe for CDKL5 deficiency disorder, tuberous sclerosis complex, and refractory status epilepticus.

  • Orion will pay Marinus €25 million as an upfront fee to Marinus and an additional €97 million in R&D reimbursement and cash milestone payments.

  • Price Action: MRNS shares are up 1.1% at $15.2 during the premarket session on the last check Tuesday.

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