Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is evoking strong interest in the pharmaceutical space after prostate drug trial success. The stock has soared to highs of $3.46 a share on heavy trading volume in recent days, amidst talk the company is closing in on a regulatory approval for its lead candidate drug. Amidst the impressive run in the market, some investors are already questioning whether the stock has been overinflated on the clinical trial success.
Fexapotide Trial Success
According to Nymox, 82% to 95% of 391 patients who received fexapotide did not need surgery to treat prostate cancer. However, that was not case for patients who received other conventional treatments over the two-to-three year study period. Posted clinical results show reduced prostate cancer incidence in men with benign prostatic hyperplasia on receiving the drug under trial.
“Fexapotide shows significant efficacy against prostate cancer as a therapeutic, and in addition has been shown to reduce the risk of prostate cancer when fexapotide is used to treat BPH,” said CEO Paul Averback.
Buoyed by the impressive clinical trials, Nymox has confirmed that it will be filling for a Food and Drug Administration approval. Past clinical trial results on Fexapotide could come to haunt the pharmaceutical company as it pursues regulatory approval.
Regulatory Hurdle
In November 2014, Nymox reported two clinical results for the drug in a study carried out on 1,000 men with enlarged prostates. As reported at the time, there was no difference between the drug and placebo in Phase III studies
Approval in the US and Europe could take much longer should regulators take into consideration the fact that the drug failed to demonstrate benefit over placebo in the 2014 report BPH already has, a number of treatment options in the market something that could further complicate Nymox pathway to regulatory approval.
Nymex-traded as a penny stock in the wake of the 2014 Fexapotide results. It has since risen to highs of $3 a share as investors bet on the drug clinching regulatory approval. Should the FDA decline to issue marketing approval, the stock could take a beating in the market.
