Apricus Biosciences Inc (NASDAQ: APRI) is having an overwhelmingly strong day in the market today, making up for some of the massive losses that we saw on the stock on Friday. The declines on Friday came as the result of news that the United States Food and Drug Administration issued a Complete Response Letter (CRL) surrounding the company’s New Drug Application. However, today, the mood surrounding the stock seems to be changing as it makes a run for the top. Today, we’ll talk about the news from the FDA that came last week, what we’re seeing from the stock today, why the stock is making a run for the top, and what we’ll be watching for with regard to APRI ahead.
FDA Rejects NDA From APRI
As mentioned above, Friday proved to be an incredibly bad day in the market for Apricus Biosciences. Unfortunately, the company announced that the FDA issued a CRL surrounding the company’s NDA of Vitaros(TM). Vitaros is a topical cream designed for the treatment of sexual dysfunction.
In the CRL, the FDA informed APRI that it could not approve the treatment in its present form. The company released broad remarks with regard to deficiencies related to Chemistry, Manufacturing, and Control, also known as CMC. However, information with regard to exactly what these concerns were was not released. Nonetheless, Richard W. Pascoe, CEO at APRI, had the following to offer:
We are disappointed with the outcome of the review given the substantial amount of CMC, clinical and non-clinical data and analysis provided to the FDA in the Vitaros resubmission. We are assessing the content of the complete response letter with our regulatory experts, including the information that may be needed to resolve the deficiencies and the time it would take to obtain such information with the goal of providing the market an update on our assessment in early march of this year.
What We’re Seeing From The Stock
As investors, we know that the news moves the market. In this case, it definitely did, leading to declines of more than 60% on Friday. However, Apricus Bioscience seems to be making the beginning of a strong recovery today. Of course, our partners at Trade Ideas were the first to alert us to the gains. At the moment (11:31), APRI is trading at $1.24 per share after a gain of $0.20 per share (19.20%) thus far today.
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Why The Stock Is Up
With no news out of APRI directly, we can only speculate as to why the stock is up. Nonetheless, we believe that we know the reason. While the FDA has rejected the CRL surrounding Vitaros, there is a ton of uncertainty here. We don’t really know why the FDA decided to reject the treatment. At the end of the day, it could be a very simple fix. If this is the case, the rejection could prove to be nothing more than a bump in the road. Sure, it would set the company back with regard to time to commercialization, but it wouldn’t be the end of the world.
Investors seem to be speculating that the review of the CRL is going well and that the company will be able to address the concerns of the FDA, bringing Vitaros to market. As a result, with hopes of this treatment not being dead in the water, we’re seeing gains in the value of Apricus Biosciences shares.
What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on APRI. In particular, we’re interested in following the story surrounding the CRL and the company’s assessment of the message from the FDA. We are expecting to see an update within weeks giving further direction. While we – and plenty of investors – are hopeful that the company will be able to bring Vitaros to market, we urge you to consider the risks here when making an investment. Nonetheless, we’ll continue to follow the story and bring the news to you as it breaks.
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