BioCentury
ARTICLE | Top Story

Keryx soars on Phase III data for Zerenex

January 29, 2013 1:28 AM UTC

Keryx Biopharmaceuticals Inc. (NASDAQ:KERX) jumped $2.63 (77%) to $6.06 on Monday after reporting that oral Zerenex ferric citrate met the primary endpoint in a Phase III trial to treat hyperphosphatemia in patients with end-stage renal disease (ESRD). The move translates to a market cap gain of $139.2 million for a closing valuation of $435.9 million. Zerenex significantly reduced mean serum phosphorus levels by 0.3 mg/dL from week 52 to week 56 vs. an increase of 1.9 mg/dL for placebo in the 183 patients in the intent-to-treat (ITT) population of the four-week efficacy assessment period (p<0.0001). Keryx said that Zerenex also met all key secondary endpoints.

The trial enrolled 441 ESRD patients on hemodialysis or peritoneal dialysis and included a 52-week safety assessment comparing Zerenex with active controls. Only patients randomized to Zerenex during the safety assessment were re-randomized to continue treatment with Zerenex or switch to placebo in the four-week efficacy assessment. ...