FDA Accepts NDA for TLX101-Px (Pixclara)

• FDA accepts Telix's New Drug Application for TLX101-Px (Pixclara), an investigational PET agent for imaging glioma
• TLX101-Px has been granted Orphan Drug and Fast Track designations by the FDA
• Approval of TLX101-Px will fulfill a significant unmet medical need for characterizing recurrent or progressive glioma

Telix Pharmaceuticals Limited announced that the United States Food and Drug Administration (FDA) has accepted the company's resubmitted New Drug Application (NDA) for TLX101-Px (Pixclara), an investigational PET agent for the imaging of glioma (brain cancer), and has assigned a PDUFA goal date of September 11, 2026. TLX101-Px has been granted Orphan Drug and Fast Track designations by the FDA. The approval of TLX101-Px will fulfill 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, and TLX101-Px has the potential to provide an important tool for clinicians in the United States. Telix's FY 2026 financial guidance does not include any revenue contribution from TLX101-Px.