The market pendulum is swinging from one side to the other, making it difficult to predict its trajectory from one session to the next. However, in the all or nothing world of biotechs, some things will always remain the same. Case in point: Marinus Pharmaceuticals (MRNS) shares surged nearly 50% in Tuesday’s trading session, following the release of positive clinical trial data.
On Monday evening, Marinus announced that in the phase 3 clinical trial of oral ganaxolone for the treatment of CDD (CDKL5 deficiency disorder) - a rare inherited type of epilepsy with treatment-resistant seizures – the study achieved the primary endpoint by showing a statistically meaningful 32.2% reduction from baseline in median 28-day motor seizure frequency compared to the 4% placebo reduction. Safety wise, the treatment was also generally well tolerated.
Next up is an NDA (new drug application) submission to the FDA, set for mid-2021, with a prospective launch by 1H22.
MRNS shares plummeted in July 2019 following ganaxolone’s failure to significantly beat the placebo in a phase 2 study of women with postpartum depression. Taking this into consideration, Cowen analyst Joseph Thome views the latest trial data as “impressive and a welcomed surprise for investors.”
Thome further said, “... Oral ganaxolone has had a challenging clinical path in other indications, we believe expectations into the pivotal CDD data were low. However, the Ph. III trial comfortably met statistical significance on the primary endpoint in a difficult to treat disease.”
The trial results weren’t Marinus’ only good news on Monday. Earlier in the day, the company also announced a five-year development contract with the Biomedical Advanced Research and Development Authority (BARDA).
The contract is to further advance the development of IV ganaxolone for the treatment of refractory status epilepticus (RSE), a life-threatening condition in which first- and second-line anticonvulsant drugs do not elicit a response among many patients.
To this end, Thome reiterates an Outperform (i.e. Buy) rating on MRNS shares without suggesting a price target. (To watch Thome's track record, click here)
Let’s take a look now at the rest of the Street’s outlook for Marinus. The stock has a Strong Buy consensus rating based on Buys only – 4, as it happens. The average price target comes in at $7 and implies possible upside of 119% over the next 12 months. (See MRNS stock analysis on TipRanks)
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