Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is trading up towards the end of the week, on the back of the company announcing that it’s on track for a regulatory submission to the agency in the US at some point during the next few weeks. The submission will mark one of the final hurdles in what has been a pretty up and down development pathway, and markets are recognizing as such. At market close on Wednesday, Nymox went for $3.57 a piece – a close to 12% premium on the day’s open.

The drug in question is called Fexapotide, and it’s one we’ve taken a look at on a few occasions over the past twelve months. It’s designed to treat a condition called benign prostatic hyperplasia, or BPH, which is a condition in which the prostate gland enlarges, and presses on the urethra and surrounding tissue. This enlarging can create some serious issues, and the current standard of care therapies in the space are once daily oral administration. Fexapotide is an injection administered directly into the prostate, and it’s single dose (in the admin form with which Fexapotide is likely going to push forward for approval).

There’s also an added benefit.

The company showed with this data that there’s a reduced chance of patients that have BPH developing prostate cancer down the line if they treat their BPH with Fexapotide than if they treat it with current SOC therapy. BPH doesn’t cause prostate cancer in itself (and it’s not a precursor to it, as many believe), but the SOC drug has been shown to increase risk of development. As such, if Nymox can get this one to market and push it to physicians on the back of the fact that it improves the chances of patient not developing prostate cancer going forward, then there’s a good chance it can swallow up a large portion of the market.

So what’s next?

The company has said it’s going to submit within the next couple of weeks, and that we’ll get some more detail as and when it does. For us, it’s all about labeling. If the company can get a label that points towards effective BPH treatment AND a reduced chance of prostate cancer development, it’s a real win and there’s a considerable upside potential on the current market capitalization.

So that’s the upside, what about the risk?

Well, we said that this one has had a bit of a rocky development pathway, and that’s an understatement. The drug actually failed a couple of phase IIIs back in 2014, and Nymox pretty much collapsed on the back of this failure. Subsequent to these studies, however, extension studies have brought data to the fore that goes against the initial failures. It’s this data on which the company is relying for its forward submission (that, and the cancer data that we referenced above) and this makes the submission a little shaky.

There’s also some uncertainty about the studies themselves. Specifically, the uncertainty is rooted in how many patients remained on the extension and qualify as randomized, because the extension was pretty drawn out (we’re talking three years), and the idea that patients might risk remaining on placebo for such a long period is a little tough to swallow.

That said, this latter point is more conjecture than fact, and if we’re going on what the company has offered up as valid information, then there’s a solid patient base from which the company can draw evidence supportive of a registration approval.

And there’s a big market on offer if Nymox can pick up said approval. Analysts have repeatedly pointed to the drug as being one of the primary drivers behind growth in the prostate enlargement space between now and 2025 (assuming approval) and data pins the current size of the market at a little over $2 billion. By the end of 2024, this is expected to grow to $4.9 billion.

As things stand, then, that’s all we know. We’re going to have to wait for the promised added detail from Nymox, or the submission itself, whichever comes first, before we can confirm exactly what the submission is targeting, and in turn, put some timeframes on any potential approval.