Shares of
Keryx BiopharmaceuticalsKERX, a biopharmaceutical company that focuses on the treatment of renal diseases, gained more than 20 percent Tuesday early Tuesday morning.
Keryx Biopharmaceuticals
announced positive top-line results from its pivotal Phase 3 study of ferric citrate for the treatment of iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease.
Kery Biopharmaceuticals stated that its Phase 3 study achieved the primary endpoint with 52 percent (61 out of 117) of patients who received ferric citrate achieving a 1g/dL or greater rise in hemoglobin at any time point during the 16-week randomized efficacy period, compared to 19 percent (22/115) in the placebo group.
"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," said John Neylan, M.D., chief medical officer of Keryx Biopharmaceuticals. "Based on these results, we plan to submit an sNDA to the FDA in the third quarter, seeking to expand the label for 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."
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