Telix secures FDA approval for brain cancer drug Pixclara

• The U.S. FDA approved Telix's novel imaging agent Pixclara to diagnose and evaluate brain cancer in adult and paediatric patients.
• The announcement provides a regulatory milestone for the radiopharmaceutical business as it expands its U.S. footprint.
• Telix aims to leverage the approval to address an estimated 24,000 new U.S. glioma cases diagnosed each year.

Telix Pharmaceuticals (ASX:TLX) received official approval from the U.S. Food and Drug Administration for its brain cancer imaging agent Pixclara.

The regulatory green light provides an FDA-approved FET-PET product to assist physicians in distinguishing recurrent glioma from treatment-related changes in patients aged one month and older.

"As the first FDA-approved PET imaging drug for glioma, Pixclara will provide physicians in the U.S. with more certainty in their diagnoses and greater confidence in their treatment planning for patients," said Telix Precision Medicine CEO Kevin Richardson.

The diagnostic drug targets gliomas, which represent approximately 30% of central nervous system tumours and 80% of malignant brain tumours.

The commercial launch will target healthcare facilities across North America to serve an addressable market of roughly 24,000 yearly U.S. glioma diagnoses.

Following the announcement, the Telix Pharmaceuticals share price was down at $15.67.

The approval marks an expansion of the Melbourne-based company’s radiopharmaceutical portfolio into neuro-oncology diagnostics.