Marinus Pharmaceuticals (NASDAQ:MRNS) surged after market close on Monday as the company announced two very promising updates for shareholders. The first announcement was that the Phase 3 trials on the use of Ganaxolone had reached its primary end-point.
Phase 3 Primary End point – what does the data suggest?
The Phase 3 results showed a 32.2% reduction in major motor seizure frequency in children and young adults suffering from CDD, a rare epileptic disorder that causes refractory seizures. MRNS advised they plan to commercialise the use of Ganaxolone for CDD patients mid-way through 2022.
“The Marigold Study has two important firsts. It’s the first double-blind placebo controlled study providing evidence of efficacy specific to CDD and the first Phase 3 trial to examine three times a day dosing of ganaxolone in pediatric patients,” said Scott Braunstein, M.D., Chief Executive Officer of Marinus Pharmaceuticals
See the full results and company outlook on the commercial launch of Ganaxolon here.
Funding from BARDA – what is the outlook Marinus Pharmaceuticals investors?
The second announcement released yesterday was that MRNS has a entered five-year development contract with the Biomedical Advanced Research and Development Authority (BARDA) to assist in the development of IV Ganaxolone to treat refractory status epilepticus (RSE). RSE is a life threatening seizure disorder, which majority of patients do not respond to first and second line treatments. The first line treatment to contain a seizure is the use of Benzodiazepines and the second line of treatment if that fails is the use of Phenytoin. BARDA see potential in Ganaxolone to provide relief for patients who do not respond to first and second line treatment.
BARDA are to fund MRNS up to $51 million in the R&D, manufacturing and distribution of the drug. Interestingly, BARDA aim to use the drug Ganaxolone in cases of chemical warfare, where nerve gasses can inflict pro-longed seizures which do not respond to Benzodiazepines or Phenytoin.
This news shows positive progression in MRNS development of Ganaxolone as a viable alternative to treat severe or prolonged seizures as well as epileptic disorders. The stock is up 60% pre-market as investors rally behind the bio-pharma. The 12 month forecasts posted by analysts according to CNN data, suggests a median target price at $6.50 – a realised return of over 200%. MRNS is definitely a stock to watch as we move into 2021.
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