Nymox Pharmaceutical Corporation (NASDAQ:NYMX) just put out data from its long term investigation into the safety and efficacy of its lead prostate candidate, and the company is up nearly 83% on the news. Premarket, it’s up another 30%. The company has been one of the more volatile stocks in small cap biotech over the last few months, and so while the volatility doesn’t come as too much of a surprise, its scope and associated volume does. Here’s why speculative volume is flowing in, and what comes next.

The drug is called fexapotide, and it’s targeting a condition called benign prostatic hyperplasia, or BPH. It’s a condition in which the prostate gland enlarges, and presses on the urethra and surrounding tissue. It happens in all men as they age, but in some individuals it can enlarge to a higher degree and cause serious issues.

It’s also a prostate cancer target. While BPH is not a precursor to prostate cancer (many wrongly believe this to be the case) the two frequently coexist. In trials, Nymox has shown that fexapotide can be used as a direct therapeutic for prostate cancer, but in the latest trial (and perhaps more importantly from a revenues perspective) the company has shown that the drug reduces the risk of cancer when it’s used as a treatment for BPH.

Why is this important?

Well, aside from the obvious benefit, it also sets it apart from many of the current standard of care treatments in the space. Not only sets it apart, but blows them out of the water. Most of the other SOCs actually increase the risk of prostate cancer as they treat the underlying BPH. Fexapotide not only doesn’t increase the risk, it reduces it.

If Nymox can get fexapotide approved as a first line treatment for BPH, therefore, it has a goo dchance of capturing a large portion of the BPH treatment market. Indeed, analaysis regularly states the drug as being one of three primary drivers behind market growth over the next five to ten years.

“Valentina Gburcik, Ph.D., GlobalData’s Director of Cardiovascular & Metabolic Disorders, states that three novel therapies will contribute to the growth of the BPH therapeutics market, including the launch of Nymox’s novel first-in-class therapy, NX-1207, in the US and Europe in 2017 and 2019, respectively.”

source

The market is currently worth a little over $2 billion. By 2024, GlobalData expects this to increase to $4.9 billion.

“The drug will also be priced at a premium compared with current products, meaning that it will contribute significantly towards the anticipated market expansion following its launch.”

So that explains the response to the recent data. What did the data actually tell us?

Well, the trial was a novel design trial, whereby patients received double blind placebo as a first step, and then went on to either take fexapotide or a current SOC of their choice. Investigators then monitored their progress over a two to three-year period, to see whether there was a discernible benefit between those that took fexapotide and those that tool SOC.

And there was.

There was 82-95% reduction in the number of patients who required surgery after they received crossover fexapotide in the trial, as compared to patients who took SOC. That’s very strong, and almost certainly sets Nymox up for an FDA approval come NDA submission.

Which brings us to timefarmes. Nymox expects to submit an NDA to the FDA at some point during the next two quarters. The submission will focus on the front line BPH target indication, with seven phase III trials worth of data backing up the efficacy hypothesis.

All told, it’s a little surprising that Nymox is currently valued at its current price, even with te latest gains. The company holds a market cap just shy of $200 million. With a potential billion-dollar market, and a candidate that looks primed for a commercialization deal (or even a takeover), this looks a little low.

Keep in mind that we will probably see some level of selloff today. The company is a tiny biotech, and much of its pre announcement volume would have been short term speculative holding. Many of these will likely book profits throughout today’s session, and this will cause a correction. We think it’s just a short term pullback, however, and that there’s plenty more upside potential in Nymox going forward.