FDA accepts Telix brain cancer imaging drug application

MELBOURNE, Australia and INDIANAPOLIS, April 10, 2026 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Company's resubmitted New Drug Application (NDA) for TLX101-Px^[1], (Pixclara®^[2], Floretyrosine F 18 or ¹⁸F-FET), an investigational PET^[3] agent for the imaging of glioma (brain cancer), and has assigned a PDUFA^[4] goal date of September 11, 2026.

The approval of TLX101-Px will fulfil a significant unmet medical need for the characterization of recurrent or progressive glioma from treatment related changes in both adult and pediatric patients^[5]. Neuroimaging of glioma with ¹⁸F-FET is already broadly recommended in international clinical practice guidelines – including NCCN Guidelines®^[6] – and TLX101-Px has been granted Orphan Drug^[7] and Fast Track^[8] designations by the FDA.

"There remains a critical unmet need in improving our ability to image residual glioma after treatment," said Thomas Hope, MD, Vice Chair, Department of Radiology and Biomedical Imaging, University of California, San Francisco (UCSF). "We have worked with Telix for the last three years to help leverage our clinical data to help make FET-PET^[9] available to patients in the United States."

Patrick Wen, MD, E. Antonio Chiocca, MD, PhD, Family Endowed Chair in Neuro-Oncology at Mass General Brigham Cancer Institute, added, "Distinguishing tumor progression from treatment-related change remains one of the most challenging aspects of glioma care. PET imaging with ¹⁸F-FET is an important tool in clinical practice worldwide, and the FDA's acceptance of this application is a meaningful step toward broader access for patients and clinicians in the United States."

Kevin Richardson, CEO, Telix Precision Medicine, added, "The FDA's acceptance of our NDA resubmission is an important milestone for Telix. We appreciate the FDA's constructive engagement and look forward to working closely with the Agency to urgently obtain approval and then bring this product to market for the benefit of patients."

Telix's FY 2026 financial guidance does not include any revenue contribution from TLX101-Px.