Marinus Pharmaceuticals Inc (NASDAQ:MRNS) Just Can't Stop Running

Marinus Pharmaceuticals Inc (NASDAQ:MRNS) is refusing to slow down. The company, which we first highlighted as being one to watch back in January when it was trading for around $1.15 a share, just logged another 10% plus gain midweek this week and currently goes for $5.87 – a more than 400% premium throughout 2017 so far.The primary driver behind this run was some slam-dunk trial data that hit press just a few weeks ago and – before that – the issuance by the FDA of Orphan Drug Designation to the drug under investigation as part of the trial in question. MRNS Daily ChartThe latest run came on the back of management taking the stage at Cantor Fitzgerald Global Healthcare Conference yesterday, at which the data mentioned above was reported and the forward path revealed (at least, to a degree – more on this shortly).All along we've been saying that this stock is about awareness – or lack thereof. When Marinus put out an early stage update at the start of this year as to how the drug in focus here, what's called Ganaxolone, fared in patients with a type of epilepsy called CDKL5, nobody really paid any attention. We did, however. We pointed out that this was a type of epilepsy that basically has no treatment options and its symptoms can be debilitating for sufferers, which are often children.Nobody has ever been able to bring a treatment to market that can really help these patients and, indeed, nobody has really ever even been able to produce anything promising in terms of efficacy data.That is, until Marinus did it at the start of this year.Markets said this was too small a sample size, etc. We said that this is a tiny patient population anyway and that the FDA isn’t going to require too much in the way of expansion to underpin approval.Again, we were spot on.So what comes next?The company hasn’t yet outlined its forward path in terms of what a pivotal trial is going to involve, mainly because Marinus isn’t yet sure itself what is needed. The company is going to sit down with the FDA near term in an attempt to hammer out a protocol and the assumption is that, if the trial can be successful against this protocol, then the agency will green light Ganaxolone for commercialization.What's really important now, then, from both a company and a shareholder perspective, is that the protocol is favorable (in the sense that it's realistically achievable). Building on this, what we would love to see at the outcome of said sit-down is that the FDA will be happy for Marinus to use the same endpoints as it did in the just-completed trial, but with a slightly extended patient population. If this turns out to be the case, all the company has to do is replicate the mid-stage data across a few more patients. Replication should be far easier than hitting fresh endpoints, so in terms of near-term action, the outcome of this meeting is incredibly important.So what specifically are we looking for from the meeting?We want to see two endpoints accepted as primary and secondary for a phase III investigation. These are median change in 28-day seizure frequency from baseline in the intent-to-treat (ITT) population as the primary and median change from baseline in seizure-free days in the ITT population as the secondary.If news hits press that the FDA is happy with these outcome goals, this stock is going to continue to run into the end of 2017 and, beyond, into the start of the pivotal study.As noted last time, there's cash on hand right now of around $20 million. If run efficiently, there's a good chance the company won't have to raise before the trial completes.Take a look at our previous coverage of this stock here. We will be updating our subscribers as soon as we know more. For the latest updates on MRNS, sign up below!Image courtesy of Caroline Davis2010 via FlickrDisclosure: We have no position in MRNS and have not been compensated for this article.