PET Agent Targeting Kidney Masses Earns FDA's Breakthrough and Fast-Track Designations

PET agent targeting kidney masses earns FDA's breakthrough and fast-track designations

The imaging agent is being developed as a noninvasive option for patients whose renal masses have been identified on CT or MRI but remain difficult to characterize.

FDA grants breakthrough status to Norroy kidney cancer imaging agent

WUXI, China, Aug. 19, 2026 /PRNewswire/ -- NORROY BIOSCIENCE (NORROY), a clinical-stage biotechnology company focused on innovative targeted radiopharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) has granted both Breakthrough Therapy and Fast Track designations to NORROY's 68Ga-NYM096, a potential radiopharmaceutical imaging agent targeting carbonic anhydrase Ⅸ (CAⅨ) for PET imaging of clear cell renal cell carcinoma (c…

ccRCC PET Imaging Agent Earns FDA Breakthrough Therapy, Fast Track Statuses

Ga-NYM096 is the first China-originated radiopharmaceutical to receive FDA breakthrough therapy designation for ccRCC.