Rockwell Medical leaps on Phase III study results for lead iron delivery drug

12 July 2013

US biopharmaceutical company Rockwell Medical (Nasdaq: RMTI) has announced successful Phase III results for its lead iron-delivery drug candidate soluble ferric pyrophosphate (SFP) for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis.

The news that SFP had met its primary endpoint was met with a sharp rise in the company’s shares, which rose 39% in premarket trade yesterday changing hands at $5.23. The company said that and SFP is expected to address an estimated $600 million US market.

The top-line results came from the long-term CRUISE-1 Phase III efficacy study of SFP. The company said that SFP met the primary endpoint, demonstrating a statistically significant mean change in hemoglobin from baseline to End-of-Treatment and met key secondary endpoints, including maintenance of hemoglobin, maintenance of reticulocyte hemoglobin, and increase in serum iron pre-to-post treatment without an increase in ferritin.

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