Telix’s Pixclara NDA Accepted By US FDA, Review Underway For Glioma Imaging Agent With September 2026 Decision Timeline

Telix has announced that the U.S. Food and Drug Administration has accepted its resubmitted New Drug Application (NDA) for TLX101-Px, also known as Pixclara (Floretyrosine F 18 or 18F-FET). This investigational PET imaging agent is being developed for the detection and assessment of glioma, a type of brain cancer. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 11, 2026, marking a key milestone in the regulatory review process.

“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.”

If approved, TLX101-Px is expected to address a significant unmet medical need by improving the ability to distinguish between recurrent or progressive glioma and treatment-related changes. This differentiation remains a major clinical challenge in both adult and pediatric patients. The use of 18F-FET in neuroimaging is already widely recommended in international clinical guidelines, including those from the National Comprehensive Cancer Network.

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.”

The candidate has received both Orphan Drug and Fast Track designations from the FDA, reflecting its potential importance in treating a rare and serious condition such as glioma. These designations are intended to accelerate development and review timelines for therapies that address unmet medical needs.

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.”

Despite this regulatory progress, Telix has clarified that it has not included any projected revenue from Pixclara in its financial guidance for FY 2026, indicating a cautious approach while awaiting regulatory approval.

Also Read

Telix Expands Board With Appointments Of Maria Rivas And Bill Jellison To Strengthen Governance And Strategy