Kidney Cancer PET Agent Earns 2 FDA Designations

The FDA granted Breakthrough Therapy and Fast Track designations to gallium-68 NYM096, an investigational positron emission tomography imaging agent being developed by NORROY Bioscience for clear cell renal cell carcinoma.

The agent targets carbonic anhydrase IX and is intended to support the noninvasive characterization of indeterminate renal masses identified through computed tomography or magnetic resonance imaging. Its proposed use is to help differentiate clear cell renal cell carcinoma from non-clear cell lesions.

Clear cell renal cell carcinoma is the most common subtype of renal cell carcinoma, accounting for approximately 70% to 80% of cases. NORROY said preliminary clinical data suggest that gallium-68 NYM096 could offer advantages over current diagnostic approaches and address unmet needs in the diagnosis and management of the disease.

Fast Track designation is intended to facilitate development and expedite regulatory review through measures that can include more frequent communication with the FDA and potential eligibility for rolling review of a new drug application. According to NORROY, the Breakthrough Therapy designation recognizes the agent’s potential to provide a meaningful clinical advantage based on preliminary evidence.

Additional clinical data are scheduled for presentation at the 2026 EANM Annual Congress. NORROY also plans to initiate phase 1 clinical trials of gallium-68 NYM096 in the United States and China. The agent has not been approved for marketing, and its safety and efficacy have not been fully established.

Source: NORROY Bioscience Co, Ltd. NORROY Bioscience granted FDA Breakthrough Therapy and Fast Track designations for kidney cancer imaging product. News release. NORROY Bioscience Co, Ltd; August 19, 2026. Accessed August 20, 2026.