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

U.S.-listed shares of Australia's Telix Pharmaceuticals TLX.AX, TLX.O fall 12.3% to $10.62

Company late on Wednesday said the U.S. FDA has declined to approve TLX250-CDX for the detection of a form of kidney cancer

Branded as Zircaix, it 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

Including session moves, TLX down 32.3% YTD