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Marinus Pharmaceuticals Inc [NASDAQ:MRNS] rallied yesterday and closed the day higher by 51%, The breakout followed news that the company’s treatment for CDKL5 Deficiency Disorder (CDD), a rare genetic epilepsy had met its phase 3 primary goals. From the trials, the company reported that in 28-days, there was a 32.2% decline in major motor seizure frequency compared to the 4% reduction when using a placebo.
The company also announced that Ganaxolone was well tolerated and that the rate discontinuation was lower than 5% of the subjects that were put under the treatment.
On the basis of these results, the company stated that it would submit an NDA for the treatment to the U.S F.D.A in the middle of 2021 The company also noted that it would make a Marketing Authorization Application (MAA) for the treatment to the European Medicines Agency within Q3 of 2021.
Commenting on the progress made so far, CEO Scott Braunstein stated that the study had a series of firsts that make it special. One of the firsts that is unique to this project is that it was a double blind placebo. This was used to give clear evidence of the treatment’s efficacy, with strict specificity to CDD.
He added that this was the first phase 3 trial that examined the dosing of ganaxolene 3 times a day in patients. The CEO further stated that he believed the company was a step closer to giving the first treatment for CDD and that the company would continue investing in ganaxolene.
Even more interesting is the CEO’s statement that the company’s successful development of a CDD treatment would create the way for the company to accelerate its studies in other treatments such as those for tuberous sclerosis complex among other rare epilepsies.
From an investor perspective, these developments point to a company that has a growing portfolio of potential revenue generating products. It is also noteworthy that the company announced that it had been awarded a contract by BARDA for the development of IV Ganaxolone.
The company stated that it had entered into a 5-year deal with BARDA (Biomedical Advanced Research and Development Authority) as part of the U.S government’s efforts to treat refractory status epilepticus (RSE), a life threatening ailment that most patients do not respond to treatment. It all points to a company whose fundamentals are getting stronger and the same will reflect in its price action over time.
About Marinus Pharmaceuticals Inc
Marinus Pharmaceuticals Inc is a biopharma company that develops therapies for rare seizures. It is headquartered in Radnor, Pennsylvania.
