Telix Pharmaceuticals Receives Permanent HCPCS Code for Gozellix, Positive

Telix Pharmaceuticals Limited has received a permanent Healthcare Common Procedure Coding System (HCPCS) code from the U.S. Centers for Medicare & Medicaid Services for its next-generation PSMA PET imaging agent, Gozellix. This code, effective from October 1, 2025, will support reimbursement and provider billing for Gozellix, aiding in clinical adoption and expanded access to PSMA PET imaging for prostate cancer patients. The extended shelf-life and flexible production options of Gozellix address logistical barriers, making it a valuable tool for PET scanning of PSMA positive lesions in men with prostate cancer. Telix is focused on improving access to precision medicine imaging in the U.S., with Gozellix receiving approval from the FDA.

The safety profile of gallium Ga-68 gozetotide, the key component in Gozellix, has been evaluated in 960 patients, with the most common adverse reactions being nausea, diarrhea, and dizziness occurring at a rate of less than 1%. It is important to note that image interpretation errors can occur with Gozellix PET, and clinical correlation is recommended to confirm findings. The performance of Gozellix for imaging of prostate cancer is affected by various factors, including serum PSA levels and site of disease. Additionally, caution should be taken regarding radiation risks and hypersensitivity reactions when using Gozellix for imaging purposes.

For more information on Telix Pharmaceuticals Limited and their products, visit their website or follow them on social media platforms such as LinkedIn and Facebook. This announcement has been authorized for release by Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. Please see the Full Prescribing Information for comprehensive details. Telix Pharmaceuticals Limited disclaims any obligation to update information contained in this announcement and suggests referring to their most recent reports with the Australian Securities Exchange (ASX) and U.S. Securities and Exchange Commission (SEC) for risk factors. Forward-looking statements in this announcement relate to anticipated future events and financial performance. All trademarks and trade names referenced belong to Telix Pharmaceuticals Limited or their respective owners.

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