Telix Pharmaceuticals Says US FDA Approves New Drug Application for Prostate Cancer Imaging Agent

MT Newswires Live

Mar 21, 2025

Telix Pharmaceuticals (ASX:TLX) said that the US Food and Drug Administration has approved its New Drug Application for Gozellix, the company's prostate-specific membrane antigen positron emission tomography (PSMA-PET) imaging agent for prostate cancer, according to a Friday filing with the Australian bourse.

Gozellix is designed for PET scanning of PSMA-positive lesions in men with prostate cancer, the filing said.

The agent offers a six-hour shelf life and extended distribution range compared to existing gallium-based imaging agents, improving access to PET scanners which currently cannot use other PSMA imaging products, filing added.

Telix expects Gozellix to expand access by qualifying for full reimbursement with reduced or no patient co-insurance, which will benefit underserved populations.

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