Marinus Pharmaceuticals, Inc. (MRNS) 49% on 09/11/17: This is why

Marinus Pharmaceuticals, Inc. (MRNS) Entry level: 4.1 | Exit level: 4.4 | Stop level: 3.98  jumped 49% as a result of Bullish news signal: Marinus Pharmaceuticals Inc. saw its shares make a huge gain to kick off the week after the firm announced top-line results from its mid-stage study in patients with  CDKL5 disorder. Essentially, the Phase 2 study of ganaxolone showed a sizable and durable seizure-frequency reduction in the majority of patients, with some achieving an increase in the number of seizure-free days and reporting behavioral benefits.

For some quick background: CDKL5 disorder is a severe, rare genetic epilepsy that results in early-onset, treatment-refractory seizures, pervasive neuro-developmental delay and disabling behavioral issues.

finviz dynamic chart for  mrns

Top-line Data:

  • The median change in 28-day seizure frequency from baseline in the ITT (intent-to-treat) population (primary endpoint) was a decrease of 43% (n=7).
  • The median change from baseline in seizure-free days in the ITT population (key secondary endpoint) was an increase of 78% (n=5; two subjects cannot be calculated due to 0 baseline seizure-free days).
  • Five of the seven children experienced a meaningful seizure reduction compared to baseline; median reduction of 65% (range 24% – 85%).
  • Three children have so far met the criteria to enter the one year study extension (completed 26-weeks of treatment with excellent seizure control) and continue to experience a median seizure reduction of 70% and median increase in seizure-free days of 75%.
  • The Clinical Global Impression Scale rated by Investigators (CGI-I) and Caregivers (CGI-P) were consistent with seizure control for all the children. Children with a 43% or higher seizure reduction were rated as “much improved” or “very much improved” by the Investigators and Caregivers.
  • Investigators and Caregivers reported improvements in attention, mood, behavior and sleep via investigator narratives.
  • Ganaxolone was generally safe and well-tolerated with no serious adverse events. To date, there have been no adverse event reports of somnolence or dizziness.
  • One child has not yet reached the 26-week visit and two children discontinued prior to completing the 26-week treatment due to lack of efficacy.

“We believe that the efficacy and safety profile of ganaxolone in this study provide compelling evidence that a definitive study in patients with CDKL5 disorder should be undertaken as soon as possible,” commented Dr. Lorianne Masuoka, Chief Medical Officer of Marinus Pharmaceuticals.  “The tolerability and complete lack of dose regimen-limiting safety concerns, as compared to the most widely used anti-epileptic drugs for this condition, could make ganaxolone an exceptional option for patients with CDKL5 disorder.”

In addition to the CDKL5 disorder cohort of patients, Marinus evaluated a cohort of Lennox-Gastaut syndrome (LGS) patients.  Based upon these robust CDKL5 disorder clinical results and etiologic fit with ganaxolone’s mechanism of action, Marinus has prioritized CDKL5 disorder as its lead pediatric orphan program for advancement into later stage clinical development.

GlobeNewswire 

Explanation:

Why Bullish? The company believes that the efficacy and safety profile of ganaxolone in this study provide compelling evidence that a definitive study in patients with CDKL5 disorder should be undertaken as soon as possible.  The stock has been impacted by the bullish news and jumped by 49%. It is very common that these type of news (i.e. positive clinical trial results) will impact the stock in a bullish manner. Therefore, we provide this stock a  short-term bullish signal

 

  Jordan Mizrahi

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