FDA approves Telix Pixclara as first FET-PET glioma imaging agent

 

• Pixclara (floretyrosine F 18) approved to differentiate recurrent/progressive glioma from treatment changes in adults and pediatrics.
• Addresses ~24,000 annual US glioma cases; first and only FDA-approved radiopharmaceutical for this use.
• Approval follows resubmitted NDA with PDUFA around Sep 11; enables broad US access to FET-PET already used internationally.
• CEO Kevin Richardson: provides physicians more diagnostic certainty and treatment planning confidence.
• Builds on strong H1 2026 results with $477M revenue (+22% YoY) and improved margins/EBITDA.
• TLX ADR surged ~9.3% in premarket Sep 14 (from $11.29 close to ~$12.34); ASX shares also rose sharply.
• Expands Telix precision medicine portfolio alongside Illuccix and Gozellix.
• Company had prior CRL but addressed with additional data for approval.

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