• Telix Pharmaceuticals resubmitted its New Drug Application to the U.S. FDA on March 16, 2026, for TLX101-Px (Pixclara®), a PET imaging agent targeting gliomas in adults and pediatrics.
• The agent received Orphan Drug and Fast Track designations from the FDA due to its potential to address unmet needs in post-treatment glioma management, with 18F-FET PET already in international guidelines but no U.S.-approved equivalent.
• Glioblastoma multiforme (GBM), the most common aggressive primary brain cancer, affects about 22,000 new U.S. cases yearly, with recurrence nearly universal and median survival of 12-15 months post-diagnosis.