Rockwell Medical Receives FDA Approval For Iron Replacement Therapy
Today Rockwell Medical (RMTI) received FDA approval for its iron replacement drug known as Triferic. Triferic is a water-soluble iron salt that is delivered straight to the bloodstream in a fashion similar to when a person eats food and receives iron from that food. Trifefic is administered directly into the bone marrow through the current dialysis process known as dialysate -- fluids and solutions sent through the body. The advantage Triferic has over current standard of care iron replacement therapy is because the drug is taken by the body directly to the bone marrow. That is because other standard of care therapies require iron to pass through the liver, which can cause iron induced liver damage.
Rockwell estimates that Triferic can obtain a market possibility of $300 million to $600 million at the market peak in the U.S. alone. There is a need for Triferic because patients with kidney disease or anemia on dialysis lose about 5 to 7 mg of iron every single time they receive dialysis. Triferic was designed as a drug to replenish the iron lost to the dialysis treatment.
With the approval of Triferic for hemodialysis patients there is a lot less risk now in this biotechnology stock. The company has a pipeline full of other drug compounds in mid-stage studies and is in the process of trying to get Triferic approved for other iron-deficiency indications.
The stock spiked briefly on the news today, but returned to normal levels by the close.
Disclosure: No positions in any stocks mentioned