Shares of Marinus Pharmaceuticals, Inc. (NASDAQ: MRNS) traded up 51.66% after announcing the encouraging result of a Phase 3 trial evaluating its drug candidate ganaxolone in children and young adults with CDKL5 deficiency disorder (CDD), a rare type of epilepsy.
After the promising result of ganaxolone, Marinus has decided to submit the New Drug Application (NDA) to the US FDA in mid-2021. Not only this, but the company has also decided to submit Marketing Authorization Application (MAA) for ganaxolone for the treatment of CDD to the European Medicines Agency (EMA) by the end of Q3 2021.
Marinus Pharmaceutical has earlier participated in Morgan Stanley Virtual Global Healthcare Conference on September 15. The biotechnology company is scheduled to participate in the Cantor Virtual Global Healthcare Conference on September 17, 2020. The company is dedicated to the development of innovative medicines for the treatment of rare disorders.
Marinus Pharmaceutical has disclosed that it has received the five-year development contract with BARDA. The contract has been awarded to the company to support the development of IV ganaxolone for the treatment of refractory status epilepticus (RSE). There are many serious causes of RSE.
Marinus Pharmaceuticals, Inc. (NASDAQ: MRNS) shares were trading up 51.66% at $3.20 at the time of writing on Tuesday. Marinus Pharmaceuticals, Inc. (MRNS) share price went from a low point around $1.01 to briefly over $3.50 in the past 52 weeks, though shares have since pulled back to $3.20. Marinus Pharmaceuticals, Inc. (MRNS) market cap has remained high, hitting $381.28 million at the time of writing.
In the Phase III trial, patients who have received the ganaxolone have shown a 32.2% median reduction in 28-day major motor frequency as compared to the 4% for placebo.
Chief Medical Officer Joe Hulihan of MRNS said that after receiving the positive result from the trial encouraged the company to accelerate the clinical studies in tuberous sclerosis complex and possibly other rare pediatric epilepsies as well.