Apricus Biosciences Inc (NASDAQ: APRI) is having a strong start to the trading session, and for good reason. The company announced news from the FDA that proved to be positive. Of course, this caused investor excitement, leading to gains in the value of the stock. As is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (8:36), APRI is trading at $1.72 per share after a gain of $0.13 per share or 8.18% thus far today.
APRI Gains On FDA News
As mentioned above, Apricus Biosciences is having an overwhelmingly strong start to the trading session in the pre-market hours this morning, and for good reason. The company announced that the United States FDA has acknowledged the receipt of it’s New Drug Application, or NDA, for Vitaros(TM). The FDA said that it considers the application complete. As a result, APRI has been given a PDUFA date for the Vitaros NDA, which has been set for February 17th, 2018, the standard 6 month review period for NDA resubmissions.
Vitaros is a treatment designed for erectile dysfunction. The novel, on-demand topical cream has been approved in Canada, Mexico, and certain countries within Latin America, Europe, and the Middle East. Currently, the product is being commercialized by Ferring International Center S.A. and its licensee throughout Europe and the Middle East. In a statement, Richard W. Pascoe, CEO at APRI, had the following to offer…
“We are very pleased to announce that the FDA has acknowledged receipt of our U.S. Vitaros NDA resubmission and our PDUFA goal date is February 17, 2018… The FDA has determined that the resubmission is a complete, class 2 response to our 2008 action letter. Importantly, we believe that Vitaros, if approved, will address a significant unmet need in the erectile dysfunction market.”
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on APRI. In particular, we’ll be following the resubmission of Vitaros, and are excited to learn the results in the beginning of next year. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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