Marinus Pharmaceuticals Inc. (NASDAQ:MRNS)
Marinus Pharmaceuticals Inc. (NASDAQ:MRNS) shares rallied 2.56% after the clinical stage biopharmaceutical company announced plans to carry out a public offering of shares of its common stock. The company intends to use net proceeds from the offering to advance the development of its treatment for rare genetic pediatric epilepsy and for working capital purposes.
Epilepsy Study Big Win
Renewed investor interest on the stock comes on the company reporting top line results in a Phase II study of ganaxolone for the treatment of the CDKL5 disorder. The stock is currently trading in an uptrend after gapping higher from $3.20 a share to highs of $5.40 a share on the positive trial results.
CDKL5 is a severe, rare genetic epilepsy that results in treatment refractory-seizures, pervasive Neuro-developmental delay and disabling behavioral issues. Phase 2 trial results indicate that ganaxolone resulted in sizable and durable seizure frequency reduction. Some of the patients also achieved an increase in the number of seizure-free days with some enjoying behavioral benefits. Ganaxolone met its primary endpoints by achieving a median decrease of 43% in 28-day seizure frequency in addition to demonstrating a 73% increase in seizure-free days.
“The durable anti-epileptic effect seen in several children distinguishes ganaxolone efficacy from the more than 20 currently available anti-epileptic drugs that provide limited seizure control lasting a few weeks to months,” said Orrin Devinsky, MD, Director of the NYU Langone Medical Center.
Regulatory Approval Push
Ganaxolone was well tolerated with no serious adverse events reported during the trials. Marinus Pharmaceuticals Inc. (NASDAQ:MRNS) plans to meet with regulatory agencies to discuss a clinical development plan that would form the basis ganaxolone approval as a novel treatment for the CDKL5 disorder.
Ganaxolone has already received an orphan drug designation from the Food and Drug Administration for the treatment of CDKL5 in adult patients. Currently, there are no approved or effective treatment options for the condition.
Separately, Marinus Pharmaceuticals Inc. (NASDAQ:MRNS) reported a net loss of (-$4.6) million or 21 cents a share for the second quarter ended June 30, 2017. Research and development expenses decreased to $2.8 million from $4.4 million, attributed to the discontinuation of the drug resistant focal onset seizure program. The company exited the quarter with cash and cash equivalent of $2.3 million which is adequate to finance operations into the fourth quarter of 2018.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.