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Benzinga
Benzinga
Business
Vandana Singh

Telix Gets Second FDA Rejection For Kidney Cancer Drug

FDA Telix Cancer William Blair
FDA

On Thursday, Telix Pharmaceuticals Limited (NASDAQ:TLX) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) for TLX250-CDx (Zircaix, 89Zr-DFO girentuximab), an investigational PET2 agent for the diagnosis and characterization of renal masses as clear cell renal cell carcinoma (ccRCC).

The CRL identifies deficiencies relating to the Chemistry, Manufacturing, and Controls (CMC) package.

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