India, April 10 -- Telix Pharmaceuticals Ltd. (TLX,TLX.AX) announced that the U.S. Food and Drug Administration has accepted its resubmitted New Drug Application or NDA for TLX101-Px (Pixclara, Floretyrosine F18 or 18F-FET), an investigational PET agent for the imaging of glioma (brain cancer).
Telix Pharma shares were gaining around 5.2 percent in Australian trading, at A$14.35, and around 10 percent in the U.S. overnight trading, at $10.78.
The agency has assigned a Prescription Drug User Fee Act or PDUFA goal date of September 11.
Gliomas are diffusely infiltrative tumors that affect the surrounding brain tissue, and are the most common form of central nervous system or CNS cancer that originates from glial cells.
The company's TLX10...