Telix Resubmits NDA for Brain Cancer Imaging Agent TLX101-Px to FDA

Telix Pharmaceuticals has resubmitted its NDA for TLX101-Px, a PET imaging agent for brain cancer, to the FDA. The resubmission addresses the complete response letter received in April 2025, which requested additional confirmatory clinical evidence. Telix believes it has appropriately addressed the CRL and filed a marketing authorisation application for TLX101-Px in Europe. The company reported a 56% increase in revenue to $803.8 million in 2025 and provided guidance for 2026 revenue in the range of $950 million to $970 million.