Apricus Biosciences Inc (NASDAQ: APRI) is falling apart early on in the trading session this morning, and for good reason. The company announced the result of an end-of-review meeting with the United States Food and Drug Administration (FDA). Unfortunately, while the result of the meeting did provide a pathway toward potential regulatory approval in the United States surrounding Vitaros(TM), required changes to the formulation and additional data needed puts the company between a rock and a hard spot on a financial level. Today, we’ll talk about:
- The result of the FDA meeting;
- what we’re seeing from APRI as a reuslt; and
- what we’ll be watching for ahead.
APRI Takes A Dive On FDA News
As mentioned above, Apricus Biosciences isn’t having the best of starts in the pre-market hours this morning. In fact, the stock is falling apart as the result of FDA-related news. In a press release issued early this morning, the company announced the outcome of an end-of-review meeting with the FDA surrounding the New Drug Application (NDA) for Vitaros(TM), the company’s experimental topical cream designed to treat erectile dysfunction.
During the meeting, the FDA said that it believes that APRI should develop a new formulation of the treatment that reduces the concentration of DDAIP.HC1 from 2.5% to 0.5%. The FDA believes that doing so will address the tumor promotion and partner transference safety concerns. Also, the FDA wants to see two more Phase 3 clinical trials surrounding the efficacy of the reformulated product before the treatment is resubmitted for approval.
The big kicker for the company, however, is cost. At the end of the day, the small, clinical-stage biotechnology company is running out of resources quickly and does not have the resources to move forward with the reformulation and clinical trials on its own. As a result, the company will need to find a partner or come up with another strategic alternative. In a statement, Richard Pascoe, CEO at APRI, had the following to offer:
While we are pleased that the FDA has outlined a clear regulatory pathway for Vitaros, which we believe provides a path to approval in the U.S., the cost and timeline associated with a reformulation effort and completing additional phase 3 clinical trials exceeds our current resources and our ability to raise additional capital. Therefore, we have initiated discussions with interested parties for the U.S. Vitaros rights to enable its continued development and potential approval in exchange for financial terms commensurate with a development stage asset. In parallel, the Board of Directors has determined that Apricus should evaluate strategic alternatives or other business combinations, with the goal of maximizing shareholder value.
What We’re Seeing From The Stock
One of the first lessons that we learn when we hit the market is that the news causes moves. In this particular case, the news released by Apricus Biosciences proved to be pretty negative. After all, while there is a pathway to potential approval of the treatment, the company needs to find a strong partner or get its hands on more resources to make it down that path, which is very concerning to investors. So, it’s no surprise to see that the stock is falling in the market this morning. Of course, our partners at Trade Ideas were the first to alert us to the declines. At the moment (9:46), APRI is trading at $0.33 per share after a decline of $0.091 per share (21.76%) thus far today.
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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 company’s goal of bringing Vitaros to the market. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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