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."