Apricus Biosciences (NASDAQ:APRI) is having an incredibly hard day in the market, and for good reason. The company has been in the midst of a Phase 2b proof of concept study that investors found out today, missed its primary endpoint. Today, we'll talk about the details of the study, what we saw in the market as a result, and what we can expect to see from APRI moving forward. So, let's get right to it...
APRI Misses Primary Endpoint
As mentioned above, Apricus Biosciences has been in the midst of a Phase 2b study. The proof of concept study was looking into fispemifene as a treatment for men with secondary hypogonadism and sexual dysfunction. Ultimately, the goal of the study was to prove that not only was fispemifene safe and tolerable, but that the treatment would improve sexual function in men with hypogonadism. According to the announcement made by APRI today, the treatment did demonstrate statistically significant improvements in total, percent free and percent bioavailable testosterone compared to a placebo. However, the magnitude of the increase was not sufficient to achieve statistical significance for either the erectile function primary endpoint or low libido secondary endpoint.
APRI also announced that the treatment was generally well tolerated. According to the results of the study, there were no new or significant safety issues that arose as a result of the treatment. Apricus announced that there were no serious adverse events experienced on fispemifene and that there were few discontinuations. Nonetheless, the study did miss its primary and secondary endpoints, causing concern for investors. In a statement, Richard Pascoe, CEO at APRI had the following to offer...
“We are obviously disappointed with these results... As a consequence of these results, we will discontinue all development of fispemifene in symptomatic secondary hypogonadism, and focus our resources on our other homegrown pipeline assets. Specifically, we will focus on growing ex-U.S. Vitaros revenues, seeking U.S. Vitaros approval in 2017, and advancing RayVa with a Phase 2 clinical development program. We believe that focusing on these higher return assets, along with streamlining the organization and reducing our operating expenses, is in the best interest of shareholders.”
How The Market Reacted To The News
One of the first things that we learn as investors is the fact that the news moves the market. Any time there is positive news revolving around a publicly traded company, we can expect to see gains in the value of the stock associated with that company. However, the news revolving around APRI is anything but positive, and when we see negative news, we can expect negative results. That's exactly what we're seeing from the stock today. Currently (9:44), APRI is trading at $0.62 per share after a loss of $0.73 per share or 54% thus far today.
What We Can Expect To See Moving Forward
Moving forward, I have a relatively mixed opinion of what we can expect to see from Apricus Biosciences. There's no denying that after the poor trial results and abandonment of a treatment, the company has a rough road ahead of them. However, I am impressed by the alternative plan the company has set forth. While I do believe that the company will make it over this hurdle, it's going to take some time. So, now definitely wouldn't be the time to get involved in this stock.