Keryx Biopharmaceuticals is having a great day in the market today after announcing that the European Commission has made the decision to approve Fexeric. Today, we’ll talk about what Fexeric is, what European approval means for KERX, how the market reacted to the news and what we can expect to see moving forward.
European Commission Approves Fexeric
Fexeric, also known as ferric citrate coordination complex is a treatment that’s designed for the control of elevated serum phosphorus levels (hyperphosphatemia) in adults with chronic kidneys disease. The treatment has been approved for both pre-dialysis and dialysis patients. The new approval in Europe provides KERX with exlusive data and marketing in Europe for Fexeric and any other ferric citrate coordination complex for the next ten years.
The decision was made by the European Commission based on evidence from approximately 1,900 patients, included in two key clinical trials. One of the trials was a 58-week non-dialysis Phase 2 study. The other trial was a Phase 3 registration trial in which ferric citrate effectively reduced serum phosphorus levels to withing KDOQI guidelines range.
Following the news of the European approval, John Neylan, M.D., CMO of Keryx Biopharmaceuticals had the following to say…
We are pleased that this medicine was approved for broad use, in both the pre-dialysis and dialysis settings, to control hyperphosphatemia in adults with chronic kidney disease… Importantly, the EU product information contains data that is reflective of Fexeric’s full clinical profile, including all of the primary and secondary endpoint data from the Phase 3 study. With Fexeric’s broad label, nephrologists have a new, well tolerated and effective phosphate binder to control hyperphosphatemia as the patient progresses through the late stages of CKD and into dialysis.”
Following John Neylan, M.D.’s comments, Greg Madison, CEO of KERX had the following to say…
“EC approval is another validation by a global regulatory agency of the medicine’s profile, and is another milestone in our efforts to expand the reach of ferric citrate to treat patients with renal disease… we continue to work with potential partners regarding commercialization in the EU, and expect to finalize our commercial strategy by the end of 2015.”
How The Market Reacted To The News
As mentioned above, Keryx Biopharmaceuticals is having an incredible day in the market today. After all, any time we see positive news surrounding a biotechnology company, that news is generally followed by a positive reaction. Currently (11:06), KERX is trading at $4.22 per share after a gain of 7.65% so far today.
What We Can Expect To See Moving Forward
Based on today’s news, I have an overwhelmingly bullish opinion of what we can expect to see from Keryx Biopharmaceuticals moving forward. Regulatory approval in Europe will lead to more sales, higher revenues, and better profits for investors. As a result, I’m expecting to see more improvements in the price of the stock.
What Do You Think?
Where do you think KERX is headed and why? Let us know in the comments below!
[Image Courtesy of Medicinet]