Telix Pharma falls after US FDA declines to approve cancer diagnostic drug

U.S.-listed shares of Australia's Telix Pharmaceuticals TLX.AX, TLX.O fall 19.1% to $9.79 premarket

Company late on Wednesday said U.S. FDA has declined to approve to its drug, TLX250-CDX, to detect a form of kidney cancer

The drug, branded Zircaix, was being tested to help detect patients with a type of kidney cancer called clear cell renal cell carcinoma via positron emission tomography scans

FDA in its so called "complete response letter" cited deficiencies and requested additional data to prove that the scaled-up commercial manufacturing process is comparable to the one used in clinical trials - TLX

Telix says it plans to request meeting with the FDA as soon as possible

"We expect investors to be disappointed by the Zircaix regulatory setback and that Telix shares will sell off," says William Blair

Up to last close, TLX down 21.4% YTD