Telix Pharmaceuticals TLX250-CDx Granted FDA Priority Review for Kidney Cancer Imaging

Telix Pharmaceuticals (ASX: TLX) announced that the U.S. FDA has accepted its Biologics License Application (BLA) for TLX250-CDx (Zircaix®), an investigational PET imaging agent for clear cell renal cell carcinoma (ccRCC). With a Priority Review and a PDUFA date of August 27, 2025, the approval could enable a U.S. commercial launch this year.

TLX250-CDx binds to carbonic anhydrase IX (CAIX), a key marker in 95% of ccRCC cases, enabling precise, non-invasive diagnosis. The pivotal Phase 3 ZIRCON study demonstrated 86% sensitivity, 87% specificity, and 93% positive predictive value, with findings published in The Lancet Oncology. CEO Kevin Richardson emphasized the potential of Zircaix® to transform kidney cancer diagnosis, similar to how PSMA-PET/CT revolutionized prostate cancer care. Telix continues expanding access through global early access programs to support patients in need.

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