Marinus Pharmaceuticals, Inc. MRNS announced successful completion of a phase II study assessing pipeline candidate, ganaxolone, for the treatment of patients with CDKL5 disorder. The data supports the advancing of the candidate in a late stage study.
Shares rallied 33% on Monday after the announcement of the news. Marinus’ share price has risen 310.9% so far this year, significantly outperforming the industry’s gain of 4.6% in the same time frame.
Ganaxolone is a CNS-selective GABAA modulator being developed in three different dose forms (IV, capsule, and liquid), intended to maximize therapeutic reach to adult and pediatric patients in both acute and chronic care settings.
The study met its primary endpoint by achieving a median decrease of 43% in 28-day seizure frequency from baseline in the intent-to-treat (ITT) patient population. The data also demonstrated an increase of 73% in seizure-free days compared to baseline in ITT patient population.
We remind investors that ganaxolone was granted orphan drug designation by the FDA in June 2017 for the treatment of adult and pediatric patients with CDKL5 disorder. We note that the company is focused on developing treatments for patients suffering from epilepsy and neuropsychiatric disorders.
CDKL5 is a rare genetic disorder, which predominantly affects girls and is characterized by seizures and severe neuro-developmental impairment that impacts the ability to walk and talk.
Currently, there is no approved treatment for this indication. The promising data for ganaxolone in the study and a potential late stage study bode well for the company..
Stocks worth considering in the healthcare sector include Adverum Biotechnologies, Inc. ADVM, Aduro Biotech, Inc. ADRO and ACADIA Pharmaceuticals Inc. ACAD. All the stocks carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aduro’s loss estimates narrowed 9.6% to $1.32 for 2017 and 20% to $1.24 for 2018 over the last 60 days. The company delivered an average earnings beat of 2.53% for the four trailing quarters.
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