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 TLX101-Px is a PET imaging candidate, which has been granted Fast Track and Orphan Drug designations by the FDA for the characterization of recurrent or progressive glioma from treatment related changes.
According to the firm, TLX101-Px targets membrane transport proteins known as L-type amino acid transporters 1 and 2 (LAT1 and LAT2), which enables it to be potentially utilized as a patient selection and response assessment tool for Telixs LAT1-targeting therapy candidate TLX101-Tx (iodofalan 131I). It is currently under investigation in the pivotal IPAX-BrIGHT trial in patients with recurrent glioblastoma.
TLX101-Px and TLX101-Tx have not received marketing authorizations in any jurisdiction.
Telix Pharma noted that the approval of TLX101-Px will fulfil a significant unmet medical need for the characterization of recurrent or progressive glioma from treatment related changes in both adult and pediatric patients. Neuroimaging of glioma with 18F-FET is already broadly recommended in international clinical practice guidelines, including NCCN Guidelines, it said.
Telixs added that its fiscal 2026 financial guidance does not include any revenue contribution from TLX101-Px.
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