Highlights

Telix Pharmaceuticals’ shares rose 12.6% to AUD 16.89 after CMS granted Transitional Pass-Through (TPT) status for Gozellix®.

Gozellix® reimbursement will be available under the U.S. Hospital Outpatient Prospective Payment System (HOPPS) effective 1 October 2025.

The imaging agent offers extended shelf life and scalable production methods, improving accessibility for prostate cancer diagnostics.

Telix Pharmaceuticals Limited (ASX:TLX) (NASDAQ:TLX) announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through (TPT) payment status for Gozellix®, its next-generation PSMA-PET imaging agent for prostate cancer.

The designation, effective 1 October 2025, allows for separate reimbursement of Gozellix® under the Hospital Outpatient Prospective Payment System (HOPPS). The TPT approval is part of CMS’ initiative to ensure patients gain timely access to innovative diagnostic tools.

In addition, CMS has assigned Gozellix® a permanent Healthcare Common Procedure Coding System (HCPCS) Level II code, A9616. This will allow recognition by both CMS and commercial health insurers, also effective from 1 October 2025. Importantly, patients will not be subject to the standard 20% coinsurance under the TPT arrangement.

Clinical Indications and Patient Benefits

Gozellix® 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. It is also approved for patients experiencing suspected biochemical recurrence (BCR), identified by elevated prostate-specific antigen (PSA) levels.

Following radiolabelling with gallium-68 (68Ga), Gozellix® enables clinicians to detect prostate cancer more effectively. This diagnostic capability is expected to support improved treatment planning and clinical decision-making for patients.

Innovations in Distribution and Production

Gozellix® offers a shelf life of up to six hours, providing a broader distribution radius compared to existing gallium-based imaging products. This advancement addresses longstanding logistical challenges that have limited patient access to PSMA-PET imaging.

The agent’s formulation supports scalable production using either gallium generators (50mCi and 100mCi) or cyclotron-based methods. This flexibility enhances efficiency, scheduling, and patient throughput at scanning clinics.

Cyclotron production is further supported by GE’s FASTlab™ system and Telix’s ARTMS QUANTM Irradiation System® (QIS®), enabling large-scale manufacturing across commercial networks and academic centers. These innovations aim to increase the availability of PSMA-PET imaging in both community and specialist care settings.

Telix Pharmaceuticals’ Global Footprint

Headquartered in Melbourne, Australia, Telix Pharmaceuticals is a biopharmaceutical company specializing in therapeutic and diagnostic radiopharmaceuticals. The company operates across multiple regions, including the United States, United Kingdom, Brazil, Canada, Europe, and Japan.

Telix’s product portfolio includes both clinical and commercial-stage programs designed to address unmet needs in oncology and rare diseases. Illuccix®, Telix’s first-generation PSMA-PET imaging agent, has already secured approvals in multiple global markets. Gozellix®, its next-generation version, has been approved by the U.S. Food and Drug Administration (FDA).