Telix announces opening of expanded access program in U.S. for TLX101-CDx

Telix Pharmaceuticals announces the opening of an expanded access program in the United States for TLX101-CDx, an investigational positron emission tomography agent for imaging progressive or recurrent glioma, following U.S. Food and Drug Administration agreement to proceed. Amino acid PET is included in U.S. and European clinical practice guidelines for the imaging of gliomas, however there is no FDA-approved targeted amino acid PET agent for brain cancer imaging currently available in the U.S. Telix’s goal is to make this product commercially available in the U.S., significantly increasing patient access to this important imaging agent for both adult and paediatric patients. The Company expects to file its New Drug Application for TLX101-CDx with the FDA during Q3 2024.