Rockwell Medical Granted Regulatory Approval in South Korea

Jan 13, 2022 By MarketDepth

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Rockwell Medical, Inc. (Nasdaq: RMTI) received regulatory approval today from the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea for its Triferic Injection.

Surge Premarket

Shares of Rockwell Medical, Inc. (Nasdaq: RMTI) surged over 51% during premarket hours following the announcement. 

Approval Granted in South Korea

The approval was granted to Rockwell Medical’s partner in South Korea, Jeil Pharmaceutical Co., Ltd., with the Triferic Injection intended for iron supplementation therapy and maintaining hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease, according to the company’s press release. Jeil is the exclusive development and commercialization partner for Triferic in South Korea, where more than 82,000 patients receive hemodialysis annually.

“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.”

Russell Ellison, M.D., President and Chief Executive Officer of Rockwell Medical

The commercial launch of Triferic is expected in June or July 2022.