FDA RMAT Designation Granted to RZ-001 for HCC

Seong-Wook Lee, CEO of Rznomics, added, “Receiving RMAT designation for RZ-001 is a profound validation of the innovation and competitiveness of our RNA editing platform by the FDA. We will concentrate our resources on global development and commercialization to provide a breakthrough therapeutic option in the field of HCC, where unmet medical needs remain exceptionally high.”

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