Rockwell Medical Jumps As FDA Panel Recommends Triferic In Hemodialysis Patients

(RTTNews) - Rockwell Medical, Inc. (RMTI) said the Oncologic Drugs Advisory Committee or ODAC of the U.S. Food & Drug Administration recommended that the Phase 3 Triferic efficacy and safety results support a positive benefit/risk to treat iron loss, to maintain hemoglobin in patients with hemodialysis-dependent stage 5 chronic kidney disease or CKD. The ODAC voted in favor of Triferic by 8 to 3.

The ODAC reviewed safety and efficacy data from Rockwell's overall clinical program. During the clinical program, over 1,400 patients were treated with Triferic and more than 100,000 individual administrations were given.

The results from the clinical trials showed Triferic to be an effective and highly-differentiated iron delivery therapy with a safety profile similar to placebo.

Robert Chioini, Founder, Chairman and CEO of Rockwell, said, "We look forward to working with the FDA to complete its review of Triferic. We remain committed to addressing the unmet needs in managing patients with chronic kidney disease."

The stock, which closed up 1.6 percent at $9.33 on Thursday, surged 35.16 percent in the extended trade.