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Marinus (MRNS) Gets Positive FDA Response for Ganaxolone Study

Shares of Marinus Pharmaceuticals Inc. MRNS rose around 4% after it announced that the FDA issued a positive response stating that the efficacy and safety data from the pivotal phase III Marigold Study on the use of oral ganaxolone in children and young adults with CDKL5 deficiency disorder (CDD) appears sufficient to support the filing of a New Drug Application (NDA). However, shares of the company have surged 38.4% in the past year against the industry’s decline of 2.6%.

CDD is a rare, genetic epilepsy with refractory seizures.

We note that Ganaxolone, a positive allosteric modulator of GABAA receptors, is being developed as intravenous and oral formulations. The company is developing the candidate in IV and oral dose formulations and aims to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings.

Marigold is the first placebo-controlled study to provide evidence of efficacy in CDD and the first phase III study to examine three times a day dosing of ganaxolone in pediatric patients. In September 2020, the company reported positive top-line data from the study. The phase III study met the primary endpoint where patients treated with ganaxolone showed a significant 32.2% median reduction in the 28-day major motor seizure frequency compared to a 4% reduction for those receiving placebo.

The company is also evaluating ganaxolone for other indications. It is initiating new sites to participate in the phase III RAISE study of IV ganaxolone for the treatment of Refractory Status Epilepticus (RSE). Marinusis also conducting a phase II Violet Study, evaluating both three times a day dosing of ganaxolone and the role of allopregnanolone sulfate as a biomarker in PCDH19-related epilepsy.

The company is also conducting a phase II Tuberous Sclerosis Complex study and expects to report top-line data in the second quarter of 2020.  

Zacks Rank & Stocks to Consider

Marinus currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the healthcare sector include Alkermes Plc. ALKS, Halozyme Therapeutics Inc. HALO and Aerpio Pharmaceuticals Ltd. ARPO. While Halozyme carries a Zacks Rank #1 (Strong Buy), Alkermes and Aerpio carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Halozyme’s earnings per share estimates have increased from 85 cents to 92 cents for 2020 and from $1.66 to $1.72 for 2021 over the past 60 days.

Alkermes’ earnings per share estimates have increased from 48 cents to 52 cents for 2021 over the past 60 days. Shares of the company have increased 12.9% in the past year.

Aerpio’s loss per share estimates have narrowed from 15 cents to 14 cents for 2020 and from 63 cents to 57 cents for 2021 over the past 60 days.

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