India, Aug. 27 -- Telix Pharmaceuticals Limited (TLX,TLX.AX) announced that it has received a Complete Response Letter (CRL) from the U.S. FDA regarding its application to approve TLX250-CDx (Zircaix), a PET imaging agent used to help diagnose kidney cancer (specifically clear cell renal cell carcinoma).
TLX closed wednesday regular tarding at $12.10 down $0.44 or 3.51%. The stock further dropped $2.20 or 18.18%.
The FDA found issues with the drug's manufacturing and quality control information. It has asked Telix to provide more data showing that the product used in clinical trials is similar to the one they plan to produce commercially. The FDA also flagged problems at two third-party manufacturing partners, which must be fixed before T...