Telix Pharmaceuticals Limited (ASX:TLX) Receives FDA Approval for Gozellix®
FDA Approval and Product Details
Telix Pharmaceuticals Limited has announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application for Gozellix® (TLX007-CDx), a next-generation PSMA-PET imaging agent for prostate cancer. Gozellix® offers a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based imaging products, enabling it to reach more PET cameras across the U.S. The product is indicated for PET scanning of PSMA positive lesions in men with suspected metastasis or recurrence based on elevated PSA levels. Additionally, Gozellix® is expected to be eligible for full reimbursement, facilitating access for underserved populations.
Executive Comments
Kevin Richardson, Chief Executive Officer of Telix Precision Medicine, stated, “Securing FDA approval for Gozellix is a major win for prostate cancer patients, who gain enhanced access to state-of-the-art 68 Ga PSMA-PET imaging. Telix continues to invest in innovation across our portfolio, and Gozellix is a testament to this continuous improvement approach. With the launch of Gozellix, our team 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.”
Motley Fool contributor Abbie Stokes has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has recommended BHP Group. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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