Shares Of Keryx Biopharmaceuticals (nasdaq: Kerx) Move Up On Initiation Of Zerenex Study
Today, shares of Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) have traded as high as $5.18, up 7% over their previous close of $4.83. With an hour left in today's trading session, KERX had traded over 1.6 million shares, which is considerably more than its 3 month average volume of about 1.2 million shares.
Keryx Biopharmaceuticals, Inc. (NASDAQ:KERX) develops and commercializes pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Although KERX has more than one candidate in its product pipeline,the company's KRX-0401 (perifosine), for the potential treatment of multiple myeloma, colorectal cancer, and additional forms of cancer, has undoubtedly brought the most attention to this Nasdaq biopharma stock. A prime reason for this is that the company's perifosine received orphan drug status as a treatment for neuroblastoma, a cancer that affects the nervous systems, typically in children. However, this is now old news for KERX, particularly when considering above average volume and intraday gains.
Today's movement, however, has been a result of a pre-market announcement from the company regarding the initiation of a long-term Phase 3 study of Zerenex(ferric citrate), an iron based phosphate binder for the treatment of elevated serum phosphorus levels, known as hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis. This long-term, multi-center study set out to gauge the safety and efficacy with planned enrollment of approximately 300 ESRD patients on hemodialysis, or peritoneal dialysis, will run 58-weeks, covering 45 sites in the United States. Additionally, KERX reported that its short-term efficacy study for Zerenex, initiated in May 2010 is expected to be completed in fourth quarter of this year.
These studies are in accordance with the company's SPA (special protocol assessments) agreement with the U.S. Food and Drug Administration, and are necessary for the FDA to provide evaluation and written guidance on the design and size of proposed protocols intended to form the basis for a new drug application (NDA). Thereafter, KERX's ability to receive marketing approval would depend on the efficacy and safety results demonstrated in the Phase 3 clinical program.
While KERX shares may have experienced a positive boost today, it would appear, at least at this point in time, that the company's KRX-0401 (perifosine) may be a more preferred subject for news.
Keryx Biopharmaceuticals, Inc. (NASDAQ:KERX) develops and commercializes pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Although KERX has more than one candidate in its product pipeline,the company's KRX-0401 (perifosine), for the potential treatment of multiple myeloma, colorectal cancer, and additional forms of cancer, has undoubtedly brought the most attention to this Nasdaq biopharma stock. A prime reason for this is that the company's perifosine received orphan drug status as a treatment for neuroblastoma, a cancer that affects the nervous systems, typically in children. However, this is now old news for KERX, particularly when considering above average volume and intraday gains.
Today's movement, however, has been a result of a pre-market announcement from the company regarding the initiation of a long-term Phase 3 study of Zerenex(ferric citrate), an iron based phosphate binder for the treatment of elevated serum phosphorus levels, known as hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis. This long-term, multi-center study set out to gauge the safety and efficacy with planned enrollment of approximately 300 ESRD patients on hemodialysis, or peritoneal dialysis, will run 58-weeks, covering 45 sites in the United States. Additionally, KERX reported that its short-term efficacy study for Zerenex, initiated in May 2010 is expected to be completed in fourth quarter of this year.
These studies are in accordance with the company's SPA (special protocol assessments) agreement with the U.S. Food and Drug Administration, and are necessary for the FDA to provide evaluation and written guidance on the design and size of proposed protocols intended to form the basis for a new drug application (NDA). Thereafter, KERX's ability to receive marketing approval would depend on the efficacy and safety results demonstrated in the Phase 3 clinical program.
While KERX shares may have experienced a positive boost today, it would appear, at least at this point in time, that the company's KRX-0401 (perifosine) may be a more preferred subject for news.
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