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Marinus' End-of-Phase II Meeting Positive for Ganaxolone

Marinus Pharmaceuticals, Inc.MRNS announced that it has successfully completed an end-of-phase II meeting with the FDA for ganaxolone, for the adjunctive treatment of focal onset seizures in adults.

The meeting was held to get a feedback from the FDA on the nonclinical and clinical programs to support registration of ganaxolone. The FDA gave a positive opinion on the company's planned path to support registration for ganaxolone and also supported the design, population and primary endpoint for two phase III studies, one of which is presently ongoing.

Ganaxolone is currently in a phase III study in adults with drug-resistant focal onset seizures. The company expects to present top-line data in the first quarter of 2016.

We note that Marinus plans to initiate a second phase III study on ganaxolone in patients aged 17 years or older, diagnosed with focal onset seizures, in 2016. The company also plans to submit the protocol for this study to the FDA under the agency's Special Protocol Assessment program.

Meanwhile, ganaxolone is in two phase II proof-of-concept studies - one for the treatment of the rare genetic disorder, PCDH19 female pediatric epilepsy and the other for the treatment of behaviors in fragile X syndrome. Top-line data from both studies are expected in 2016.

Ganaxolone has orphan drug designation in the U.S. for the treatment of PCDH19 female epilepsy.

Marinus carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Gilead Sciences Inc. GILD , Regeneron Pharmaceuticals, Inc. REGN and Nexvet Biopharma Public Limited Company NVET , each sporting a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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