The stock, Marinus Pharmaceuticals Inc. (MRNS) touched a new 52-week high of $3.80 today, and is currently trading at $3.79, up $1.68 or 79.63% in the regular session. Trading volume surges over 29.9 million versus an average volume of 1.92 million shares.
Marinus Pharma announced positive top-line results from its registrational Phase 3 clinical trial evaluating the use of oral ganaxolone in children and young adults with CDKL5 deficiency disorder or CDD, a rare, genetic epilepsy with refractory seizures.
In the trial, patients given ganaxolone showed a significant 32.2% median reduction in 28-day major motor seizure frequency, compared to a 4.0% reduction for those receiving the placebo, achieving the primary endpoint. Ganaxolone was generally well tolerated with a safety profile consistent with previous clinical studies.
Further, Marinus said it plans to submit an NDA for ganaxolone in the treatment of CDD to the U.S. Food and Drug Administration or FDA in mid-2021 and a Marketing Authorization Application or MAA for ganaxolone for the treatment of CDD to the European Medicines Agency or EMA by the end of Q3 2021.
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