Building on the success of a significant core business, Rockwell Medical is setting a new standard for anemia patients and caregivers
It’s a truly under-addressed medical market. Despite the advancements of modern science, iron deficiency anemia afflicts a subset of the two billion people worldwide who are nutritionally iron deficient.
Moreover, approximately 10 million people are iron deficient in the United States, including 5 million who have iron deficiency anemia. The need for innovative therapies is pressing, and one biotech up-and-comer is stepping up to the plate in a big way.
Rockwell Medical (RMTI) leverages a powerful therapeutic process that’s developed to replace iron loss in patients with anemia in an entirely different way. Rockwell’s unique and differentiated molecule, Ferric Pyrophosphate Citrate (FPC), provides a novel mechanism of action with a physiologic approach.
FPC technology has the potential to lead to transformative treatments for iron deficiency in multiple disease states, reduce health-care costs, and improve patients’ lives. And for investors, there’s an opportunity to take a position before a major data release could send the RMTI share price much higher.
A Closer Look at HMTI Stock
The big day is May 17, 2021: that’s when Rockwell Medical will report the company’s financial and operating results for the first quarter of 2021.
Could this be the catalyst that propels RMTI stock to 2x, 3x or greater gains? It’s entirely possible as the perfect setup has been months in the making.
In early May, the stock came down to rest at a support level of around $1. That’s where RMTI stock sat in late December, before the buyers scooped up the shares and sent RMTI up to $2.
Soon enough, we’ll find out if there will be a repeat of this amazing price performance. It would be a real shame if you sat on the sidelines and watched it happen, without having a dog in the race.
Terrific Triferic
Rockwell Medical’s FPC-driven tech has a multitude of core capabilities. Among them is addressing iron-level maintenance in chronic kidney disease patients, which the company does through an FPC platform called Triferic.
Triferic is unique as it’s the first and only FDA-approved treatment indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease.
In fact, two Triferic formulations have already been approved by the FDA. The first one is Triferic Dialysate, which was launched in the U.S. in May 2019; it delivers 100% bioavailable iron, resulting in hemoglobin stability for hemodialysis-dependent chronic kidney disease patients.
The second formulation is Triferic AVNU (for intravenous use); this was commercially launched in the U.S. on February 9, 2021.
Triferic AVNU is a line extension of Triferic for dialysis patients which opens new opportunities for Rockwell Medical’s portfolio as it can be used regardless of the bicarbonate technology type used, thereby providing clinics the flexibility to individualize treatment.
A Milestone Moment in Canada
This development is hot off the presses, with perfect pre-earnings-event timing. Reportedly, Health Canada just issued Rockwell Medical a Notice of Compliance (marketing approval) for Triferic AVNU for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease.
Clearly, this event represents a quantum leap forward on Triferic AVNU’s timeline to North American commercialization. And this could happen surprisingly soon, as Rockwell Medical expects Triferic AVNU to become commercially available in Canada sometime in 2022.
Plus, in Canada, Rockwell Medical has a distribution agreement with RMC Health Care, Inc. to sell Triferic AVNU. So, that piece of the puzzle is also already in place.
Rockwell Medical President and CEO Russell Ellison noted the historic significance of this event, saying, “The approval of Triferic AVNU by Health Canada is the first international regulatory approval for our intravenous therapy and marks important progress for our strategy to bring Triferic to markets around the world.”
Dr. Ellison also observed that this product will serve a severely under-met need in the medical space: “There are more than 20,000 Canadians undergoing dialysis. We expect Triferic AVNU to be an important new treatment option for dialysis clinics and the patients they serve.”
The Bottom Line
RMTI is coiling for a rally, and really it doesn’t need anything beyond Rockwell Medical’s groundbreaking, FDA-approved products to move forward.
Yet, if the upcoming earnings event happens to add a dose of fuel to the RMTI stock rocket ship, so be it – that’s just a quicker gain for early investors.
