Why Shares Of Rockwell Medical Were Trading Higher On Monday

Shares of

were trading higher by eight percent on Monday after the company announced the FDA has approved its Triferic (ferric pyrophosphate solution) intended for the maintenance of hemoglobin in adult patients with hemodialysis dependent chronic kidney disease. The FDA's decision stems from a review of safety and efficacy data from Rockwell's clinical program that included more than 1,400 patients who were treated with Triferic and more than 100,000 individual administrations were given. The results have shown that Triferic is an effective and highly-differentiated iron delivery therapy with a safety profile similar to placebo. Dr. Raymond Pratt, Chief Medical Officer of Rockwell stated, "We are very excited about this drug approval. We see Triferic as a paradigm shift in the treatment of anemia. Importantly, Triferic is the first product that can safely allow dialysis patients to maintain target hemoglobin without the need for IV iron. Data suggests that we have been overloading our dialysis patients with IV iron, and this is an increasing concern to the hemodialysis community. Triferic offers a more physiologic way to deliver and maintain iron balance in hemodialysis patients."