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
.