Research & Development
Rznomics' RZ-001 receives US FDA Orphan Drug Designation
5 February 2024 -

Rznomics Inc., a South Korea based biopharmaceutical company, announced on Friday that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to RZ-001 intended for the treatment of patients with Hepatocellular carcinoma (HCC).

The ODD allows the product to receive seven years of marketing exclusivity upon product approval, exemption from user fee and tax credits. It is also expected to provide access to specialised regulatory assistance from the FDA's Office of Orphan Products Development (OOPD).

Seong-Wook Lee, Rznomics CEO and founder, said, 'This FDA Orphan Drug Designation further underlines the potential of our pipeline to expeditiously address the current unmet medical needs of patients with Hepatocellular Carcinoma.'