(Reuters) -The U.S. Food and Drug Administration has requested additional data from Telix Pharmaceuticals 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.
(Reporting by Sameer Manekar, Padmanabhan Ananthan and Puyaan Singh in Bengaluru; Editing by Rashmi Aich)
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