Akers Biosciences Inc (NASDAQ: AKER) is falling hard in the pre-market hours this morning, and for good reason. The company announced that it has withdrawn an application for 510(k) marketing approval with the FDA. Of course, the news of the withdrawn application is leading to concerns among investors and sending the value of the stock spiraling downward. Today, we’ll talk about:
- The news;
- what we’re seeing from the stock; and
- what we’ll be watching for with regard to AKER ahead.
AKER Announces Withdrawn 501(k) Application
As mentioned above, Akers Biosciences isn’t having a great day in the market today. In fact, the stock is spiraling out of control after announcing that it has withdrawn an application. In a press release issued early this morning, the company announced that, upon a recommendation from the United States Food and Drug Administration (FDA), it has decided to withdraw its initial 510(k) application for PFIA Chlamydia. Upon withdrawing the application, AKER plans to reevaluate its options with regard to the product and the opportunity surrounding the development of the product.
In a statement, John J. Gormally, CEO at AKER, had the following to offer:
The setback to the desired commercialization timeline for this product is disappointing, however, PIFA Chlamydia continues to be a priority for the Company, and the board believes this course of action will allow the board and management to better evaluate all options.
At the same time, we remain focused on driving sales growth of our currently commercialized products and, in particular, PIFA Heparin/PF4 Rapid Assay, through expanded distribution and a strategic focus on clinical end-users and integrated delivery network customers.
What We’re Seeing From The Stock
As investors, one of the first lessons that we learn is that the news moves the market. In the case of Akers Biosciences, the news proved to be overwhelmingly negative. After all, the withdrawn application means that 510(k) approval won’t be coming down the line any time soon. Unfortunately, the company may not resubmit the application once it has had the opportunity to reevaluate options based on the advice of the FDA. So, it’s no surprise to see that the stock is tanking in the market this morning. Of course, our partners at Trade Ideas were the first to alert us to the declines. At the moment (8:41), AKER is trading at $0.41 per share after a loss of $0.18 per share (31.15%) 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 AKER. In particular, we’re interested in following the company to see what its next moves are following the news of the withdrawn application. Nonetheless, we’ll keep our eyes on the news and continue to bring it to you as it breaks!
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