• FDA accepts BLA for Telix's investigational kidney cancer PET imaging agent TLX250-CDx (Zircaix)
• FDA grants Priority Review and provides PDUFA date of 27 August 2025
• If approved, Zircaix will become the first commercially available imaging agent to accurately diagnose and characterize clear cell renal cell carcinoma

Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its breakthrough investigational kidney cancer PET imaging agent TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granted a Priority Review and provided a PDUFA date of 27 August 2025, paving the way for a U.S. commercial launch in 2025. If approved, TLX250-CDx will become the first commercially available imaging agent to accurately and non-invasively diagnose and characterize clear cell renal cell carcinoma (ccRCC), the most common and one of the most aggressive sub-types of kidney cancer. The BLA is based on Telix's successful global Phase 3 ZIRCON study, which demonstrated a sensitivity of 86%, specificity of 87% and a positive predictive value (PPV) of 93% for ccRCC, including in very small, difficult-to-detect lesions. The results of this study were published in The Lancet Oncology in September 2024. Telix believes Zircaix has the potential to revolutionize the management of kidney cancer, just as PSMA-PET/CT scanning has changed the management of prostate cancer, by providing a more definitive clinical diagnosis for renal masses and helping physicians make more timely and confident patient management decisions.

Subject to regulatory approval, Telix is preparing to bring the Zircaix precision medicine product to market in 2025.