RMTI having a nice run on news.
Rockwell Medical Inc. (RMTI) said results from a study of its investigational iron-delivery drug in chronic kidney disease patients receiving hemodialysis were positive.
Shares jumped 7.2% to $5.94 in recent premarket trading. Through Tuesday's close, the stock has risen 35% in the past three months.
The successful top-line results are from Rockwell's long-term CRUISE-2 Phase 3 efficacy study of the treatment, called SFP.
In the study, SFP met the primary endpoint, demonstrating a statistically significant mean change in hemoglobin from baseline to end-of-treatment. Additionally, Rockwell--a biopharmaceutical company targeting end-stage renal disease and chronic kidney disease--said SFP 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.
It said the latest long-term study is the second and final study of two identical Phase 3 efficacy studies to provide clinical data required for the company to file a New Drug Application with the U.S. Food and Drug Administration.
"This second Phase 3 study produced identical results to the first in demonstrating statistical significance and meeting the primary efficacy endpoint," Chief Executive Rob Chioini said. "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."
Rockwell in July said results were positive from the first Phase 3 study of SFP.
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