Opko Health Inc. (NYSE: OPK)
Opko Health is having an incredible start to the trading session today, and for good reason. The company announced that it has received the FDA approval it was looking for. Today, we’ll talk about the news from the FDA, how the market reacted to the news, and what we can expect to see from OPK moving forward. So, let’s get right to it…
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OPK Announces FDA Approval
As mentioned above, Opko Health is having a strong start to today’s trading session after announcing that it has received an approval from the United States Food and Drug Administration. According to the announcement, the FDA has made the decision to approve RAYALDEE extended release capsules for the treatment of secondary hypothyroidism.
The approval comes following strong results of 2 double blind phase 3 clinical trials. In these trials, OPK was able to show that a larger proportion of stage 3 and 4 CKD patients with SHPT and vitamin D insufficiency achieved significant reductions in plasma intact parathyroid hormone when treated with RAYALDEE as compared to those treated with the placebo. In a statement, Dr. Phillip Frost, CEO and Chairman at OPK, had the following to offer with regard to the new approval:
“FDA’s approval of RAYALDEE represents an important milestone for OPKO… RAYALDEE is the first product to receive FDA approval for this important indication and is one of OPKO’s many pharmaceutical products being developed for significant medical problems which will benefit from new treatment options.”
The above statement was followed up by Dr. Charles W. Bishop, CEO of the Renal Division at OPK, who had the following to offer:
“RAYALDEE fills a large void in the current treatment options for SHPT in predialysis patients… The current standard of care is high dose vitamin D supplementation, an approach for treating SHPT that is neither FDA approved nor demonstrated to be safe and effective in this population. SHPT is a progressive disease that becomes increasingly debilitating and difficult to treat, necessitating timely and effective treatment.”
How The Market Reacted To The News
As investors, one of the first things that we learn is that the news moves the market. Any time positive news is released with regard to a publicly-traded company, we can expect to see gains in the value of the stock associated with the company as a result. Adversely, when negative news is released, it generally leads to declines. The news that was released with regard to OPK today was overwhelmingly positive. So, it’s only natural that we’re seeing gains in the value of the stock. Currently (9:52), Opko Health stock is trading at $9.57 per share after a gain of $0.38 per share, or 4.11%, thus far today.
What We Can Expect To See Moving Forward
Moving forward, I have an overwhelmingly bullish opinion of what we can expect to see from OPK. The reality is that the company has worked hard to bring RAYALDEE to patients in need, and now, thanks to the FDA’s approval of the treatment, that goal will be achieved. Being the first treatment approved by the FDA for this indication, the drug will likely lead to incredible increases in revenue and profits. All in all, I’m expecting to see gains in the long run.
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What Do You Think?
Where do you think OPK is headed moving forward and why? Join the discussion at TalkTRENDZ!
[Image Courtesy of Wikimedia]