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Marinus Stock Down on Dismal Phase III Data on Ganaxolone
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Shares of Marinus Pharmaceuticals, Inc. (MRNS - Free Report) plunged 69.7% after the company announced disappointing top-line results from a phase III study on ganaxolone for the treatment of adults with drug-resistant focal onset seizures.
Data from the study revealed that ganaxolone failed to demonstrate a statistically significant difference when compared with placebo. Consequently, the study did not meet the primary endpoint of a percent change in the 28-day seizure frequency from baseline.
The safety profile of ganaxolone was, however, reportedly consistent with the previously conducted studies. The candidate was safe and generally well tolerated.
Marinus said that it plans to discontinue the development of ganaxolone in adult focal onset seizures. Instead, the company now plans to focus on evaluating the candidate in other indications such as status epilepticus and pediatric orphan indications.
Marinus is developing ganaxolone in three different dose forms – intravenous (IV), capsule and liquid. The candidate is currently being evaluated in two phase II proof-of-concept studies – for the treatment of PCDH19 epilepsy in the pediatric population and for the treatment of Fragile X syndrome. Top-line data from both the studies are expected shortly.
Meanwhile, the company expects to initiate a phase I study on the candidate for the treatment of status epilepticus in 2016. Ganaxolone (IV) was granted Orphan Drug designation by the FDA in Apr 2016 for the treatment of status epilepticus.
The decision to stop evaluating ganaxolone for adult focal onset seizures is a huge setback for Marinus, as the company is highly dependent on ganaxolone for growth. Positive data from the study would have enabled the company to file regulatory application and gear up for the launch of its first drug in the market.
Going ahead, we expect investor focus to remain on further details pertaining to the development of ganaxolone in other indications.
Marinus currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Bristol-Myers Squibb Company (BMY - Free Report) , ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Pfizer Inc. (PFE - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).
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Marinus Stock Down on Dismal Phase III Data on Ganaxolone
Shares of Marinus Pharmaceuticals, Inc. (MRNS - Free Report) plunged 69.7% after the company announced disappointing top-line results from a phase III study on ganaxolone for the treatment of adults with drug-resistant focal onset seizures.
Data from the study revealed that ganaxolone failed to demonstrate a statistically significant difference when compared with placebo. Consequently, the study did not meet the primary endpoint of a percent change in the 28-day seizure frequency from baseline.
The safety profile of ganaxolone was, however, reportedly consistent with the previously conducted studies. The candidate was safe and generally well tolerated.
Marinus said that it plans to discontinue the development of ganaxolone in adult focal onset seizures. Instead, the company now plans to focus on evaluating the candidate in other indications such as status epilepticus and pediatric orphan indications.
Marinus is developing ganaxolone in three different dose forms – intravenous (IV), capsule and liquid. The candidate is currently being evaluated in two phase II proof-of-concept studies – for the treatment of PCDH19 epilepsy in the pediatric population and for the treatment of Fragile X syndrome. Top-line data from both the studies are expected shortly.
Meanwhile, the company expects to initiate a phase I study on the candidate for the treatment of status epilepticus in 2016. Ganaxolone (IV) was granted Orphan Drug designation by the FDA in Apr 2016 for the treatment of status epilepticus.
The decision to stop evaluating ganaxolone for adult focal onset seizures is a huge setback for Marinus, as the company is highly dependent on ganaxolone for growth. Positive data from the study would have enabled the company to file regulatory application and gear up for the launch of its first drug in the market.
Going ahead, we expect investor focus to remain on further details pertaining to the development of ganaxolone in other indications.
Marinus currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Bristol-Myers Squibb Company (BMY - Free Report) , ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Pfizer Inc. (PFE - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.Click to get this free report >>