• FDA approves Telix's next-generation PSMA-PET imaging agent Gozellix
• Gozellix provides longer shelf life and extended distribution radius compared to existing gallium-based products
• Potential to enhance efficiency, scheduling flexibility and throughput of scanning clinics

Telix Pharmaceuticals Limited announced that the United States Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Gozellix (TLX007-CDx, kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix's next-generation PSMA-PET imaging agent for prostate cancer. Gozellix, after radiolabeling with 68Ga, is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Gozellix provides a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based imaging products, allowing it to reach PET cameras that are currently not served by any PSMA imaging providers. The innovative formulation also has the potential to enhance the efficiency, scheduling flexibility and throughput of scanning clinics. Gozellix builds on the success of Telix's established PSMA-PET imaging agent, Illucix, and will be available alongside the first-generation product, providing choice for customers and patients based on their individual needs. Securing FDA approval for Gozellix is a major win for prostate cancer patients, who gain enhanced access to state-of-the-art 68Ga PSMA-PET imaging.

Telix expects Gozellix to be eligible for full reimbursement with reduced or no patient co-insurance, meaning it can reach more patients, particularly in underserved populations.

Telix is excited to be bringing the new generation of prostate cancer scanning to more American men, delivered with the reliability, service and flexibility that customers have come to expect from Telix.