Telix Pharmaceuticals Pixclara (Floretyrosine F 18) FDA PDUFA Action Date Arrives Friday September 11 for PET Imaging of Recurrent or Progressive Glioma
Telix Pharmaceuticals Limited (NASDAQ: TLX) reached its FDA Prescription Drug User Fee Act (PDUFA) action date of Friday September 11, 2026 for TLX101-Px (Pixclara, floretyrosine F 18, also called 18F-FET), an investigational positron emission tomography (PET) imaging agent designed to help distinguish recurrent or progressive glioma from treatment-related changes in adult and pediatric patients with previously treated glioma. The FDA had accepted the resubmitted NDA in April 2026 following an earlier complete response letter. Pixclara carries FDA Fast Track and Orphan Drug designations. Standard MRI post-treatment surveillance struggles to differentiate true tumor progression from pseudoprogression or radiation necrosis; a PET imaging agent that binds selectively to actively metabolizing tumor cells addresses a substantial diagnostic gap. If approved, Pixclara would be one of the first tumor-specific glioma PET agents to enter the U.S. market. The company had not confirmed the FDA action outcome as of end of Friday U.S. business hours; investors were watching for a Monday morning announcement.