2305 GMT [Dow Jones]--Telix Pharmaceuticals's shares have fallen more than 50% from February's high on setbacks that include the rejection by the Food and Drug Administration of two promising products. Telix in late August said the FDA had identified deficiencies relating to the chemistry, manufacturing, and controls package for its Zircaix kidney cancer imaging product. Telix also plans to resubmit a new drug application for its Pixclara brain cancer imaging product. Citi thinks both can be remediated. Zircaix is probably the easier ask, given the rejection was for manufacturing, it says. "We cannot think of a good example of a biopharma company giving up on a significant pipeline asset at this point for CMC-related reasons," analyst Laura Sutcliffe says. "We expect FDA to want resolution of any problems at third party sites before resubmission." (david.winning@wsj.com)

(END) Dow Jones Newswires

September 30, 2025 19:09 ET (23:09 GMT)

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