Rockwell Medical Receives FDA Approval: Stock Sees 6% Growth

Rockwell Medical

Followers of Rockwell Medical Inc. (NASDAQ:RMTI) have reason to celebrate today, as does the medical community. The Michigan-based biopharmaceutical company announced today that it received FDA approval for the intravenous formulation of its novel, physiologic iron maintenance therapy Triferic.

The new form of the therapeutic is Triferic AVNU. As it is designed for direct intravenous infusion, it can provide hemodialysis patients with greater access to the Triferic platform and expand administration options for clinicians.

Triferic AVNU now joins Triferic Dialysate—a previously approved form of the drug designed to be administered via liquid bicarbonate—as the only FDA-approved products indicated to replace iron and maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease.

Stuart Paul, President and CEO of Rockwell Medical, calls the approval of Triferic AVNU a “major milestone” for the company. He adds:

“With Triferic AVNU, more adult hemodialysis patients in the US will have access to the benefits of this unique therapeutic, regardless of the way their clinic generates bicarbonate. Clinicians will now have the added flexibility to administer Triferic intravenously to a broader group of patients who can benefit from physiologic iron maintenance therapy to manage their anemia.”

Triferic is Transforming Anemia Management

Patients with anemia lack enough healthy red blood cells to adequately carry oxygen to tissues throughout the body. Approximately 2.8 million Americans and more than 1.62 billion people around the world currently suffer from this condition. 

According to Rockwell Medical, more than $4 billion is spent on anemia management therapies every year in the US-based concentrated provider market. To manage their anemia, a substantial majority of patients receive iron therapy and an erythropoiesis-stimulating agent (ESA). Unfortunately, these are costly and carry cardiovascular risks

Fortunately, Triferic addresses the daily iron needs of dialysis patients while avoiding iron toxicity. The therapy also significantly reduces ESAs while maintaining hemoglobin levels. 

In the press release, Dr. Steven Fishbane, Chief of Nephrology of Northwell Health, is quoted as saying:

“Clinical trials have demonstrated that patients treated with Triferic receive steady and consistent bioavailable iron to replace the iron that is lost at every dialysis treatment and hemoglobin is maintained. Now, even in clinics where delivering Triferic through the dialysate is not operationally possible, Triferic AVNU is an option. This may be especially important for patients who are difficult to manage, or for other special patient populations.”

Rockwell Medical’s Commercialization Strategy

Rockwell estimates that the global market opportunity for Triferic could exceed $1 billion.

Over the next several months, the company will initiate a strategy to lay the groundwork for the commercial introduction of Triferic AVNU. To accomplish this, it will leverage the experience gained from the 2019 launch of Triferic Dialysate.

In Q3 2020, Rockwell Medical expects to launch evaluation programs  to allow clinics to gain direct experience with Triferic AVNU. Once these initial programs are completed, the new formulation of the therapy will likely become commercially available. 

RMTI shares skyrocketed on the news of the FDA approval. After a quick correction, the stock is currently trading at $2.28, which represents 6.61% growth over the last week. RMTI has also received favorable coverage from Wall Street recently, as well as attractive price targets from analysts. 

For more developments from Rockwell Medical, keep watching this space.

Featured image: DepositPhotos © Goir

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