Marinus Pharmaceuticals Inc

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Products, Expansion, Regulatory

Marinus says Ganaxolone Achieves Primary Endpoint In Phase 3 Trial For a Rare Form of Genetic Epilepsy

Published: 09/14/2020 21:55 GMT
Marinus Pharmaceuticals Inc (MRNS) - Marinus Pharmaceuticals Says Ganaxolone Achieves Primary Endpoint in Phase 3 Trial for Cdkl5 Deficiency Disorder (cdd), a Rare Form of Genetic Epilepsy.
Marinus Pharmaceuticals - Ganaxolone Trial Met Primary Endpoint, Median 28-day Major Motor Seizure Frequency Reduction of 32.2% Versus 4.0% for Placebo.
Marinus Pharmaceuticals - Ganaxolone Was Generally Well Tolerated With a Safety Profile Consistent With Previous Clinical Studies.
Marinus Pharmaceuticals - Trial Showed Numerical Trends Favoring Ganaxolone Across Several Predefined Secondary Endpoints.
Marinus Pharmaceuticals - Ganaxolone Did Meet Statistical Significance in Exploratory Secondary Endpoints in Phase 3 Trial.
Marinus Pharmaceuticals - Trial Showed Ganaxolone Did Not Meet Statistical Significance in Predefined Secondary Endpoints.
Marinus - Plan to Launch an Expanded Access Program in Q4, for Patients Unable to Participate in Trial to Begin Receiving Treatment With Ganaxolone.
Marinus Pharmaceuticals - New Drug Application Submission Planned for Mid-2021 for Ganaxolone; Commercial Launch Targeted for H1 2022.
Marinus Pharmaceuticals - Recently Received FDA Feedback on Protocol for Its Planned Phase 3 Trial for Iv Ganaxolone in Refractory Status Epilepticus.
Marinus - Plan to Submit a Marketing Authorization Application for Ganaxolone for Treatment of Cdd to European Medicine Agency by End of Q3 2021.