Telix Pharma : FDA Accepts BLA For TLX250-CDx For Kidney Cancer Imaging

(RTTNews) - Telix Pharmaceuticals Limited (TLX,TLX.AX) announces that the U.S. Food and Drug Administration has accepted the Biologics License Application or BLA for its breakthrough investigational kidney cancer PET1 imaging agent TLX250-CDx (Zircaix2, 89Zr-DFO-girentuximab). The FDA granted a Priority Review and provided a PDUFA3 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 company said in a statement.

TLX closed Tuesday's regular trading at $19.50 down $1.43 or 6.83%. But in the after-hours trading, the stock gained $0.89 or 4.56%.

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