Nymox Pharmaceutical Corporation (NASDAQ:NYMX) Runs Up On Submission News, What's Next?

Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is an end of the week runner in the biotechnology space this week, having gained close to 17% on its latest announcement. The company is a young biotech that drew a fair amount of negative attention from our competitors over at The Street towards the end of last year, but has traded strong throughout 2017 to date, and looks set to gain strength further as the year matures.Here is our take on the latest release, with a look at what we expect (and what we're looking for) from Nymox going forward.For those new to the company, and as mentioned, it's a biotechnology stock that has a current focus on the development of a treatment called Fexapotide. The drug is under investigation in an indication of benign prostatic hyperplasia, or BPH. BPH is one of the most commonly diagnosed conditions in the US (among the male population) and can impact health and quality of life, as well as lead to things like acute urinary retention, incontinence, and other serious consequences.Fexapotide is an injectable treatment and has been in development for more than a decade. Trials to date have produced excellent data (whatever other publications might have readers believe) and phase 3 studies reported recently have shown that group can reduce the primary symptoms of BPH, while also reducing the necessity (long-term) for surgery by up to 95% compared to current standard of care therapies in space. There is also data that suggests the risk of prostate cancer is reduced in patients that receive Fexapotide as a BPH treatment.So, the latest news refers to the company's announcement that it has filed for marketing authorization in Europe for Fexapotide.In Europe, the process is pretty much the same as it is in the US, with the filing going to the European medicines agency (EMA) as opposed to the FDA. Once with the agency, the filing company (in this instance, of course, Nymox) waits for a response – be it positive or negative. The agency in Europe, and we're saying this as a general observation as opposed to anything based on hard fact, is often slightly more lenient when it comes to new drugs than is the FDA in the US. The EMA probably wouldn't like to hear us say that, but it's true. That's not an indication that Fexapotide is a shoo-in for approval, but we think it has a good chance come decision date. This is a patient population that is crying out for a fresh option to hit shelves, and there don't seem to be any major safety concerns that would inhibit the drug's chances of picking up a regulatory green light on the most recent application. If successful, the European thumbs up would open up markets in Netherlands, the UK, Germany, France and Spain.So what is next?This initial application represents the first step in what we see as a major push from Nymox in the global approval for this asset. The next major market and the most important from our perspective (and, we imagine, that of wider markets) is the US. So far, we haven't had any indication as to when the company plans to submit an NDA. Last month, management put out a release saying it expected to submit its first regulatory filing within a few weeks, and some suggested that this may be in the US. As it turns out, it referred to the jus-announced filing in Europe.So, we're looking for the US submission as a major near-term catalyst, as well as – looking slightly beyond the submission – any decision from the EMA in Europe as to the drug's success or failure on the back of the just-filed application.We will be updating our subscribers as soon as we know more. For the latest updates on NYMX, sign up below!Disclosure: We have no position in NYMX and have not been compensated for this article.