Breaking Finance News

Rockwell Medical is Up Big Wednesday- Why? (RMTI)

Shares of Rockwell Medical (NASDAQ: RMTI) are up more than 8 percent Wednesday morning after the company announced that its late stage drug, Soluble Ferric Pyrophosphate (SFP), met its main goal of improving hemoglobin levels in adult patients with chronic kidney disease.

The study represents the second of two Phase 3 trials–each reporting positive results.

Rob Chioini, Founder, Chairman and CEO of Rockwell Medical stated, “As we were with CRUISE-1, we are thrilled with the successful outcome of this CRUISE-2 efficacy study. This second Phase 3 study produced identical results to the first in demonstrating statistical significance and meeting the primary efficacy endpoint. The data again shows that in place of IV iron, SFP appears safe and effective as an iron replacement therapy that consistently maintains hemoglobin levels without increasing iron stores. The demonstrated efficacy and excellent safety data from each of the two Phase 3 CRUISE efficacy studies gives us great confidence in obtaining FDA regulatory approval. These successful results, coupled with the recent positive PRIME study data demonstrating SFP’s ability to significantly reduce ESA use, support our belief that SFP will establish a new paradigm in iron therapy treatment for hemodialysis patients. We believe that upon FDA approval, SFP will become the new standard of care in iron therapy.”

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Disclosure: At the time of this writing, the author had no position in the company mentioned.

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