NORROY’s 68Ga-NYM096 Receives FDA Breakthrough Therapy and Fast Track Designations
Norroy bioscience, a clinical-stage biotechnology company focused on targeted radiopharmaceuticals, has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy and Fast Track designations to 68Ga-NYM096, an investigational PET imaging agent for clear cell renal cell carcinoma (ccRCC).
The radiopharmaceutical targets carbonic anhydrase IX (CAIX) and is being developed as a non-invasive imaging option for evaluating indeterminate renal masses identified through computed tomography (CT) or magnetic resonance imaging (MRI).
The technology is intended to help distinguish ccRCC from other types of renal lesions and support more informed clinical decision-making.
The Breakthrough Therapy designation recognises preliminary clinical evidence indicating that 68Ga-NYM096 could provide meaningful benefits compared with existing diagnostic approaches.
Fast Track status may enable more frequent discussions with the FDA, regulatory guidance during development and potential eligibility for rolling review of a New Drug Application.
NORROY said the programme is the first China-originated innovative radiopharmaceutical to receive FDA Breakthrough Therapy Designation.
The company plans to present further clinical findings at the 2026 EANM Annual Congress.
It also intends to begin Phase I clinical trials in China and the US, while continuing regulatory discussions with the FDA to advance the programme.
The development could strengthen the role of targeted radiopharmaceutical imaging in the diagnosis and management of ccRCC.
