Telix Files NDA for TLX101-CDx (Pixclara) Brain Tumor Imaging Agent Page 1

MELBOURNE, Australia, Aug. 28, 2024 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TLX101-CDx, (Pixclara¹, ¹⁸F-phloretyrosine or ¹⁸F-FET), a research PET² agent for the characterization of progressive or recurrent glioma (brain tumors) due to treatment-related changes in both adult and pediatric patients.

Given the potential to address a significant unmet medical need, Pixclara¹ has been granted Orphan Drug status³ and Fast Track⁴ designation by the FDA, which allows for expedited review and closer consultation with the agency during the review process. FET PET (Pixclara¹) has already been included in the international clinical practice guidelines for glioma imaging⁵but there is currently no FDA-approved targeted amino acid PET agent for imaging brain tumors in adults and children commercially available in the U.S.