Keryx Biopharmaceuticals (NASDAQ: KERX)
Keryx Biopharmaceuticals is having an incredible start to the day today, and for good reason. The company announced top line results for a recent Phase 3 study that met its primary endpoint. Today, we’ll go over the details of the results, what we’re seeing in the market, and what we can expect to see from KERX moving forward. So, let’s get right to it!
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KERX Announces Positive Top-Line Results
As mentioned above, Keryx Biopharmaceuticals announced solid top-line results for a Phase 3 clinical study of ferric citrate. Ferric citrate is an oral, iron-based medicine that KERX is currently developing as a treatment for iron deficiency anemia in adults with stage 3 to 5 non-dialysis dependent chronic kidney disease. During the study, the company met its primary endpoint, showing that patients who received ferric citrate achieved a 1g/dL or greater rise in hemoglobin at any time-point during the 16-week randomized efficacy period, compared to 19 percent in the placebo group. The secondary endpoint was also achieved. During the study, ferric citrate was generally well tolerated and adverse events were consistent with its known safety profile. In a statement, John Neylan, M.D., chief medical officer at KERX had the following to offer:
“These Phase 3 results demonstrate that ferric citrate can effectively raise hemoglobin levels in stage 3 – 5 non-dialysis dependent chronic kidney disease patients, with effects observed as early as two weeks post-treatment initiation…. Based on these results, we plan to submit an sNDA to the FDA in the third quarter, seeking to expand the label of ferric citrate to include the treatment of iron deficiency anemia in people with stage 3 – 5 NDD CKD. We believe that the ability to treat iron deficiency anemia, managing hemoglobin and iron levels, could have an important effect on the way kidney specialists treat these patients.”
How The Market Reacted To The News
As investors, one of the first things that we learn is that the news moves the market. This is especially the case in the biotechnology market. Any time it is announced that a biotechnology company has met its primary endpoint with regard to clinical testing, we tend to see the stock associated with that company soar. That’s exactly what we’re seeing from KERX today. Currently (10:24), the stock is trading at $5.15 per share after a gain of $0.60 per share or 13.19% 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 Keryx Biopharmaceuticals. The truth is that iron deficiency anemia is a very common complication associated with CKD, and the prevalence and severity of IDA increases as the disease progresses. In the United States, it is estimated that about 1.6 million people are currently dealing with stage 3 – 5 non-dialysis dependent chronic kidney disease and iron deficiency anemia. Currently, there is no treatment approved that can do the things that ferric citrate is known to do. As a result, if the FDA approves the treatment as a treatment for iron deficiency anemia, it will be the only treatment available to patients suffering with this complication. This means that it will likely be overwhelmingly profitable, sending KERX upward as a result of strong revenue and earnings generated from the treatment. Considering the results, I see no reason that the FDA would decline the treatment. As such, I’m expecting to see incredibly long-run gains!
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What Do You Think?
Where do you think KERX is headed moving forward and why? Let us know your opinion in the comments below!
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