Rockwell's Triferic cleared for marketing by US FDA

The US Food and Drug Administration has approved US biopharma company Rockwell Medical’s (Nasdaq: RMTI) Triferic (ferric pyrophosphate solution) for commercial sale as an iron replacement product to maintain hemoglobin in adult patients with hemodialysis dependent chronic kidney disease. Rockwell’s share leapt 15.5% to $12.49 in pre-market trading on release of the news, but fell back to $11.09 (+2.6%) by mid-morning.

Robert Chioini, founder, chairman and chief executive of Rockwell, commented: "Triferic's unique ability to be delivered via dialysate and to deliver iron without increasing iron stores strengthens its potential to become the market-leading iron therapy treatment for hemodialysis patients. We view today's FDA decision as a major development both for Rockwell and for the entire hemodialysis patient population who now have a significantly better treatment option for addressing their iron losses."

The FDA reviewed safety and efficacy data from Rockwell's overall clinical program. During the clinical program more than 1,400 patients were treated with Triferic and more than 100,000 individual administrations were given. The results from the clinical trials have shown Triferic to be an effective and highly-differentiated iron delivery therapy with a safety profile similar to placebo.