TLX101-Tx is Telix's investigational LAT1-targeted therapeutic candidate in clinical development for recurrent or progressive glioblastoma. It is being studied in an ongoing multicenter Phase 2 trial and remains unapproved. The program is linked mechanistically with LAT1-targeted imaging strategies in the same portfolio.
Telix gained FDA alignment to advance ProstACT Global Phase 3 into U.S. Part 2 for TLX591-Tx in mCRPC, with safety data from Part 1 deemed sufficient. The trial will combine the therapy with abiraterone, enzalutamide, or docetaxel, pending IND amendment review.
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.
