According to the company, this USD20m straight-debt financing, coupled with its recent USD40m equity financing, will provide it with sufficient cash to get SFP to commercial launch.
Also, the company said that it is on schedule to release Phase 3 efficacy data for CRUISE-1.
Rockwell is conducting two pivotal Phase 3 efficacy studies, CRUISE-1 and CRUISE-2, each study being a prospective, randomised, placebo-controlled, multicentre study to demonstrate efficacy and safety of SFP-iron, delivered via dialysate, in adult chronic kidney disease (CKD) patients requiring haemodialysis. The primary efficacy end-point for both studies is the mean change in haemoglobin from baseline, the company said.
SFP is a unique iron compound that is delivered to the haemodialysis patient via dialysate, replacing the 5mg to 7mg of iron lost during a dialysis treatment.
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