16 March 2026 - Telix Pharmaceuticals today announces the resubmission of a new drug application to the US FDA for TLX101-Px, (Pixclara, floretyrosine F 18 or 18F-FET), an investigational PET imaging agent for the characterisation of recurrent or progressive glioma from treatment related changes in both adult and paediatric patients.

Telix has resubmitted the NDA with the additional data requested by the FDA. The Company believes, based on the Type A meeting and on-going consultation with the FDA, that the additional data and statistical analysis, along with the primary data set provided in the original submission, appropriately addresses the complete response letter.

Read Telix Pharmaceuticals press release