US FDA accepts Telix application for prostrate cancer imaging kit
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The news: The US Food and Drug Administration (FDA) has accepted Telix Pharmaceuticals’ New Drug Application (NDA) for a proprietary cold kit for the preparation of imaging for prostate cancer.
The numbers: Telix said its TLX007-CDx kit’s innovative properties are designed to facilitate more flexible production, including with currently approved gallium-68 (68Ga) PSMA-PET imaging agents.
This will further expand the availability, distribution and scheduling flexibility of PSMA-PET imaging. The FDA must respond to the application by 24 March, 2025.
Telix shares were down 7% at $18.85 in early trading on the ASX.
The context: Telix had submitted the NDA for the kit with the FDA in May. The PSMA-PET imaging represents a major advancement in prostate cancer management and in the US and has replaced conventional imaging methods including bone scan and CT scan as the standard of care after initial diagnosis and biochemical recurrence.
Earlier this year, the company secured a fast track designation for an investigational brain tumour imaging product from the FDA.
Separately, after market close on Tuesday Telix said it raised $650 million through a convertible bond issue bearing interest at a rate of 2.375% and due 2029. The funding will allow the company to execute strategic priorities and capitalise on future opportunities, it said.
The sources: ASX announcement, ASX announcement
