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Rznomics Announces U.S. FDA Regenerative Medicine Advanced Therapy Designation Granted to 'RZ-001' for Hepatocellular Carcinoma
Rznomics a biopharmaceutical company specializing in RNA-based gene therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) Designation to RZ-001, its lead investigational candidate for the treatment of hepatocellular carcinoma (HCC).
About this update from Rznomics Inc.
[{"type":"text","content":"RMAT designation based on promising Phase 1b/2a clinical data, including safety profile and preliminary response rates, with trans-splicing ribozyme-based RNA editing platform","length":215,"tagName":"p"},{"type":"text","content":"SEOUL, South Korea, May 8, 2026 /PRNewswire/ -- Rznomics a biopharmaceutical company specializing in RNA-based gene therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) Designation to RZ-001, its lead investigational candidate for the treatment of hepatocellular carcinoma (HCC).","length":363,"tagName":"p"},{"type":"image","alt":"Rznomics Inc. logo (PRNewsfoto/Rznomics)","displaySize":"","headline":null,"caption":"Rznomics Inc. logo (PRNewsfoto/Rznomics)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":112,"url":"https://media.zenfs.com/en/prnewswire.com/f7ff902d0dacca8515c91d28e54f7652"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/Zh_VGfx.9g88e0qrdZhe2g--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTE5Nw--/https://media.zenfs.com/en/prnewswire.com/f7ff902d0dacca8515c91d28e54f7652","width":400,"height":112},"resize_sm":{"url":"https://s.yimg.com/ny/api/res/1.2/0NEvsv4YNjFw_7Y0OqjSXw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTY0MDtoPTE3OQ--/https://media.zenfs.com/en/prnewswire.com/f7ff902d0dacca8515c91d28e54f7652","width":400,"height":112}},"href":"https://mma.prnewswire.com/media/2961309/RznomicsLogo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"RMAT designation is a specialized FDA program created to accelerate the development and review of promising new therapies, including gene therapies, intended to treat serious or life-threatening conditions. Applicant is required to submit preliminary clinical evidence suggesting the potential to address unmet medical needs. This designation provides important opportunities during the drug development process, including increased FDA guidance and eligibility for priority and rolling reviews, as well as accelerated approval pathways. By streamlining these regulatory milestones, the program aims to bring transformative innovations to patients more quickly.","length":661,"tagName":"p"},{"type":"text","content":"RZ-001 is the next-generation oncology therapeutics based on Rznomics' proprietary tran...