- Rockwell Medical (RMTI) says its iron-delivery drug SFP met its primary endpoint of "demonstrating a statistically significant mean change in hemoglobin from baseline to EOT" in the CRUISE-2 Phase 3 study.
- SFP also met secondary endpoints including "maintenance of hemoglobin, maintenance of reticulocyte hemoglobin, and increase in serum iron pre-to-post treatment without an increase in ferritin."
- Data from CRUISE 1 and 2 will support an NDA which the company says it "has great confidence in" given the trial results. (PR)
- RMTI +12.5% premarket
Rockwell Medical reports positive results from CRUISE-2, shares rise
Sep 4 2013, 08:12 ET