TLX101-Px (proposed brand Pixclara; floretyrosine F 18/18F-FET) is an investigational PET imaging agent for characterization of recurrent or progressive glioma versus treatment-related changes in adults and children. The U.S. FDA accepted Telix's resubmitted NDA in April 2026 and assigned a September 11, 2026 PDUFA date. The product has not yet received marketing authorization.
Telix Pharmaceuticals reported full-year 2025 revenue of US$803.8 million, up 56% year-over-year, driven by strong growth in its Precision Medicine segment and the successful U.S. launch of Gozellix. The company issued 2026 revenue guidance of US$950-970 million and advanced multiple regulatory filings and late-stage pipeline programs.
Telix Pharmaceuticals has submitted regulatory applications for TLX101-Px, a brain cancer imaging agent, to both the European Medicines Agency and the U.S. Food and Drug Administration, seeking approval for glioma diagnosis and treatment monitoring.
Telix Pharmaceuticals submitted a marketing authorization application in Europe for TLX101-Px, a glioma imaging agent, on February 18, 2026. The filing covers major European markets and a U.S. NDA submission will follow.
