Rockwell Medical (RMTI) Stock Rockets on Regulatory Approval

Rockwell Medical Inc (NASDAQ: RMTI) is screaming for the top in the market this morning, and for good reason. The company announced a new regulatory approval, setting the stage for a new revenue opportunity. Here’s what’s going on:

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RMTI Announces Regulatory Approval

In a press release issued early this morning, Rockwell Medical said Jeil Pharmaceutical, its South Korean partner, has received regulatory approval by the Ministry of Food and Drug Safety, or MFDS, in the Republic of Korea. 

The approval surrounds the company’s Triferic Injection, marketed in the United States as Triferic AVNU. The treatment is indicated for iron supplementation therapy and maintaining hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. 

In the press release, RMTI reminded investors that it has an exclusive license agreement with Jeil Pharmaceuticals for the rights to commercialize Triferic in South Korea. As part of this agreement, Jeil is the exclusive development and commercialization partner for the drug in South Korea. Moreover, Rockwell Medical will supply the product to Jeil Pharmaceuticals. 

Also as part of the agreement, RMTI received an upfront fee and will be eligible for future milestone and royalty payments. It is expected that the product will begin selling in the region in June or July of this year. 

Management Commentary

In a statement, Russell Ellison, M.D., President and CEO at RMTI, had the following to offer:

“The approval by MFDS is an important milestone for Rockwell Medical, but more importantly, for the more than 82,000 patients in South Korea undergoing hemodialysis. With its considerable development and commercialization capabilities and local market expertise, we believe Jeil is well positioned to ensure that hemodialysis patients have access to our innovative therapeutic across South Korea. Today’s announcement marks another meaningful advancement for Triferic, as we build our global footprint and increase the long-term value of Triferic.”

The Bottom Line

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The bottom line here is simple, investors have a very good reason to be excited here. With the new approval, an audience of tens of thousands of targeted patients per year is now open to the company. That means there’s significant potential for revenue growth. All told, this is great news! 

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