Is Nymox a Fluke or Is It Back?

Nymox announced Wednesday that is undertaking further analysis of its pivotal Phase 3 studies of NX-1207 for prostate enlargement (BPH). This will include new long-term data from Studies NX02-0017 and NX02-0018. Ultimately, the company expects to provide these new pivotal Phase 3 study results in the second or early third quarter of this year.

The NX02-0017 and NX02-0018 studies were initiated in 2009. NX02-0017, which consisted of 499 patients randomized, was completed in 2012. NX02-0018 had 498 randomized patients and was completed in 2013. At 12 months post-treatment, there was no overall top-line statistical significance for the efficacy of treatment in terms of BPH Symptom Score improvement versus controls. The safety profile of NX-1207 was excellent.

ALSO READ: Does the Mylan Secondary Make Its Stock Cheap?

Dr. Paul Averback, CEO of Nymox, commented on this undertaking:

Despite the setback of top-line results not initially beating controls statistically at 12 months post-treatment in these large studies, we continue to believe that NX-1207 has enormous potential for long-term management of BPH. Additional new blinded protocol data from the same pivotal studies is being prospectively captured in order to assess long-term results in patients up to 5 years after a single injection of NX-1207 2.5 mg vs placebo.

The company also reported its financial results just the day before this announcement was made. Nymox reported a net loss of $0.13 per share on a mere $331,909 in revenue for the year ended in December 2014.

At the same time, NX-1207 is also in late-stage development for low grade localized prostate cancer. Note that in 2014, Nymox reported eight-month efficacy results showing statistically significant reduced cancer progression in patients who received NX-1207 compared to standard of care.

Nymox shares began their run on Tuesday, moving up 27% to close at $0.84. The stock continued its climb on Wednesday, up 50% to $1.26. Finally, shares of Nymox closed Thursday up 37.6% to $1.73, in a 52-week trading range of $0.33 to $5.76. The stock has a consensus analyst price target of $10.25.

ALSO READ: Dyax Sees Big Increases in Analyst Price Targets