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US FDA seeks more information on Telix Pharma's diagnostic drug for kidney cancer
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US FDA seeks more information on Telix Pharma's diagnostic drug for kidney cancer
Aug 27, 2025 7:13 PM

Aug 28 (Reuters) - The U.S. Food and Drug Administration

has requested additional data from Telix Pharmaceuticals ( TLX )

on its application for a diagnostic drug to detect a

form of kidney cancer, the Australian cancer diagnostics firm

said on Thursday.

The U.S. drug regulator cited deficiencies relating to its

manufacturing and supply chain processes, and requested

additional data to prove that the scaled-up commercial

manufacturing process is comparable to the one used in clinical

trials.

"Telix believes these concerns are readily addressable and

submission remediation will begin immediately," the company said

in an exchange filing.

Shares of the Sydney-listed diagnostics firm plunged as much

as 24% in early trade on Thursday, marking their worst intra-day

decline on record. They were last trading 14% lower at A$15.80,

and were the worst performers in the ASX 200 benchmark index

.

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