FDA panel backs Rockwell's Triferic

Rockwell Medical Inc. (NASDAQ:RMTI) gained $1.22 (13%) to $10.55 on Friday after FDA's Oncologic Drugs Advisory Committee voted 8-3 that the benefits of Triferic soluble ferric pyrophosphate citrate outweigh the risks. ODAC based its decision on Phase III trials to treat iron loss to maintain hemoglobin in patients with hemodialysis-dependent stage 5 chronic kidney disease (CKD).

Rockwell said FDA reviewers did not recommend postmarket studies in the indication. ...