Telix Resubmits NDA to FDA for Pixclara Brain Cancer Imaging

• Telix resubmits New Drug Application (NDA) to FDA for TLX101-Px (Pixclara®), an investigational PET imaging agent for glioma (brain cancer)
• TLX101-Px has been granted Orphan Drug and Fast Track designations by the FDA
• Resubmission includes additional data requested by the FDA to address the Complete Response Letter

Telix Pharmaceuticals Limited has announced the resubmission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-Px, (Pixclara®, Floretyrosine F 18 or 18F-FET), an investigational PET imaging agent for the characterization of recurrent or progressive glioma (brain cancer) from treatment related changes in both adult and pediatric patients. Telix has resubmitted the NDA with the additional data requested by the FDA. The Company believes, based on the Type A meeting and ongoing 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. Given the potential to address significant unmet medical need, TLX101-Px has been granted Orphan Drug and Fast Track designations by the FDA. PET imaging with 18F-FET is already included in international clinical practice guidelines for the imaging of gliomas, however there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.S.