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Marinus Releases Positive Preliminary Data from CDKL5 Study
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Marinus Pharmaceuticals, Inc. (MRNS - Free Report) , announced positive preliminary data from the initial CDKL5 pediatric patients enrolled in its ongoing phase II study assessing pipeline candidate, ganaxolone, for the treatment of orphan, genetic disorders.
Marinus’ share price has declined 77.4% in the past one year, underperforming the Zacks classified Medical-Drugs industry’s fall of 13.1% 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 enrolled four pediatric CDKL5 patients in the cohort, who received up to 1800 mg/kg of ganaxolone per day for an average treatment of five-months. There was a reduction in seizure frequency compared to baseline ranging from 52% to 88% in three of these patients. Two of these patients have completed six-months of treatment and have elected to participate in the study extension. However, one discontinued the study after four-months of treatment due to lack of efficacy.
The study is currently enrolling patients and top-line data is expected in mid-2017. Once this study is complete, Marinus will assess the candidate for a breakthrough therapy and also apply for orphan drug designation from the FDA. We note that the company is focused on developing treatments for patients suffering from epilepsy and neuropsychiatric disorders.
We note that this phase II study is currently accepting patients at five sites in the U.S. and one in Italy. The study is designed to enroll up to 10 patients with each of CDKL5 disorder, Lennox Gastaut Syndrome (LGS) and PCDH19 pediatric epilepsy. The study is actively enrolling CDKL5 and LGS patients Though the PCDH19 cohort of the study has stopped enrolling patients, children are still receiving ganaxolone in the study extension.
Zacks Rank & Key Picks
Marinus currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. (ANIK - Free Report) , Sunesis Pharmaceuticals, Inc. and Enzo Biochem, Inc. (ENZ - Free Report) . While Anika and Sunesis sport a Zacks Rank #1 (Strong Buy), Enzo Biochem carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates for 2016 and 2017 were up 3.9% and 0.5%, respectively, over the last 60 days. The company recorded a positive earnings surprise in each of the last four quarters, the average being 33.14%. Its share price was up 37.2% in the past one year.
Sunesis’ loss estimates narrowed 5.06% and 8.80% for 2016 and 2017, respectively, over the past 60 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 0.54%.
Enz Biochem’s loss estimates for 2017 narrowed 5.88% over the past 60 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 22.50%. Its share price was up 47.9% in the past one year.
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Marinus Releases Positive Preliminary Data from CDKL5 Study
Marinus Pharmaceuticals, Inc. (MRNS - Free Report) , announced positive preliminary data from the initial CDKL5 pediatric patients enrolled in its ongoing phase II study assessing pipeline candidate, ganaxolone, for the treatment of orphan, genetic disorders.
Marinus’ share price has declined 77.4% in the past one year, underperforming the Zacks classified Medical-Drugs industry’s fall of 13.1% 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 enrolled four pediatric CDKL5 patients in the cohort, who received up to 1800 mg/kg of ganaxolone per day for an average treatment of five-months. There was a reduction in seizure frequency compared to baseline ranging from 52% to 88% in three of these patients. Two of these patients have completed six-months of treatment and have elected to participate in the study extension. However, one discontinued the study after four-months of treatment due to lack of efficacy.
The study is currently enrolling patients and top-line data is expected in mid-2017. Once this study is complete, Marinus will assess the candidate for a breakthrough therapy and also apply for orphan drug designation from the FDA. We note that the company is focused on developing treatments for patients suffering from epilepsy and neuropsychiatric disorders.
We note that this phase II study is currently accepting patients at five sites in the U.S. and one in Italy. The study is designed to enroll up to 10 patients with each of CDKL5 disorder, Lennox Gastaut Syndrome (LGS) and PCDH19 pediatric epilepsy. The study is actively enrolling CDKL5 and LGS patients Though the PCDH19 cohort of the study has stopped enrolling patients, children are still receiving ganaxolone in the study extension.
Zacks Rank & Key Picks
Marinus currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. (ANIK - Free Report) , Sunesis Pharmaceuticals, Inc. and Enzo Biochem, Inc. (ENZ - Free Report) . While Anika and Sunesis sport a Zacks Rank #1 (Strong Buy), Enzo Biochem carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates for 2016 and 2017 were up 3.9% and 0.5%, respectively, over the last 60 days. The company recorded a positive earnings surprise in each of the last four quarters, the average being 33.14%. Its share price was up 37.2% in the past one year.
Sunesis’ loss estimates narrowed 5.06% and 8.80% for 2016 and 2017, respectively, over the past 60 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 0.54%.
Enz Biochem’s loss estimates for 2017 narrowed 5.88% over the past 60 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 22.50%. Its share price was up 47.9% in the past one year.
Marinus Pharmaceuticals, Inc. Price
Marinus Pharmaceuticals, Inc. Price | Marinus Pharmaceuticals, Inc. Quote
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest tickers for the entirety of 2017?
Who wouldn't? These 10 are painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. They are our primary picks to buy and hold. Be among the very first to see them >>