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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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