Telix shares advance on US FDA application approval for glioma imaging agent
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More news: Shares in Telix Pharmaceuticals jumped on the ASX after the US Food and Drug Administration (FDA) accepted the Melbourne-based biotechnology company's drug application for a glioma imaging agent.
Telix shares were up 2.7% to $21.68 by midday AEDT, having more than doubled in value since the turn of the year.
Telix's glioma imaging agent application accepted by US FDA
The news: The US Food and Drug Administration (FDA) has accepted Telix Pharmaceuticals’ drug application for a glioma imaging agent.
The context: The application has also been granted priority review which could allow for a US commercial launch in 2025.
Gliomas are the most common primary brain tumours of the central nervous system, with low survival rates.
The imaging agent, TLX101-CDx (Pixclara), will help doctors diagnose and make decisions related to glioma tumours in both adult and paediatric patients. Telix said there were currently no FDA-approved agents for adult and paediatric brain cancer imaging commercially available in the US.
What they said: Telix precision medicine chief executive Kevin Richardson said: “Telix believes that the FDA approval of Pixclara will drive a step-change for brain cancer imaging in the US, and bring it into line with a more advanced standard of care currently used in other markets”.
“There is currently a critical need for better imaging in brain cancer, and Telix is dedicated to delivering precision medicine solutions that address patient needs and enhance both cancer imaging and treatment outcomes,” he said.
