Rockwell Medical (NASDAQ: RMTI) is currently trading at $5.72, up $0.36 or 6.72%. Rockwell is a fully-integrated biopharmaceutical company offering products and services targeting end-stage renal disease, chronic kidney disease, and iron deficiency anemia. The company currently provides products that are used to maintain human life by removing toxins and replacing critical nutrients in the bloodstream of dialysis patients. It is working on the development of unique, proprietary renal drug therapies for iron treatment. These exclusive renal drug therapies will support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of SFP for indications outside of hemodialysis.
Today, the company announced that it has successfully completed an End of Phase II meeting with the U.S. Food and Drug Administration regarding the company’s lead drug candidate Soluble Ferric Pyrophosphate (SFP), a novel continuous iron-replacement therapy designed to treat iron deficiency anemia in hemodialysis patients. During the meeting, Rockwell solicited input on the Company's planned Phase III clinical program for SFP. As a result of those conversations with the FDA, Rockwell has confirmed a change in hemoglobin is an approvable endpoint for the Phase III trial design. The Company will now use data from the prior Phase IIb study of SFP to finalize the Phase III protocol for FDA submission.
"Meeting with the FDA to review our Phase IIb data and solicit input for our planned Phase III program was an important corporate and clinical milestone," said Robert L. Chioini, Chairman, CEO and President of Rockwell. "The FDA provided clear and valuable feedback for our proposed Phase III program and we now have an acceptable endpoint for our Phase III trial design. We are incorporating the FDA's comments into a final protocol design, which will be submitted shortly, and we expect to remain on track to initiate the Phase III program later this year."
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