TLX101-Px

April 10, 2026: Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX) announced the FDA has accepted its resubmitted New Drug Application (resubmitted March 13, 2026) for TLX101-Px (Pixclara; Floretyrosine F 18 / 18F-FET), an investigational PET imaging agent for characterization of recurrent or progressive glioma versus treatment-related changes in adult and pediatric patients. The FDA assigned a PDUFA goal date of September 11, 2026. TLX101-Px has FDA Orphan Drug and Fast Track designations. Telix said FY2026 financial guidance excludes any revenue contribution from TLX101-Px and noted the product is not yet approved in any jurisdiction.

The release also notes TLX101-Px targets LAT1/LAT2 transporters and could potentially be used for patient selection/response assessment for Telix’s LAT1-targeting therapy candidate TLX101-Tx (iodofalan 131I), which is being studied in the pivotal IPAX-BrIGHT trial in recurrent glioblastoma (ClinicalTrials.gov NCT07100730).