Shots:
- NORROY BIOSCIENCE reported that the FDA has granted Breakthrough Therapy and FTD to 68Ga-NYM096, a radiopharmaceutical imaging agent targeting CAIX for PET imaging of clear cell renal cell carcinoma (ccRCC)
- 68Ga-NYM096 is being developed as a non-invasive PET imaging agent to characterize indeterminate renal masses identified by CT or MRI and help differentiate ccRCC from non-ccRCC lesions
- NORROY plans to initiate P-I studies in China and the US, with additional clinical data expected at the 2026 EANM Annual Congress. The FTD may support expedited development and review through enhanced FDA interactions and potential rolling NDA review
Ref: BioSpace | Image: Norroy Bioscience | Press Release
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