FDA accepts Telix brain cancer imaging drug application

The U.S. Food and Drug Administration has accepted Telix Pharmaceuticals Limited's (NASDAQ: TLX) resubmitted New Drug Application for TLX101-Px, an investigational PET imaging agent for brain cancer. The FDA assigned a PDUFA goal date of September 11, 2026.

TLX101-Px, also known as Pixclara or Floretyrosine F 18, is designed to image glioma and distinguish between recurrent cancer and treatment-related changes in both adult and pediatric patients. The drug has received Orphan Drug and Fast Track designations from the FDA.

Gliomas represent approximately 30% of all brain and central nervous system tumors and 80% of malignant brain tumors. The U.S. sees roughly 24,000 new glioma cases annually, according to the company's statement based on medical literature.

"There remains a critical unmet need in improving our ability to image residual glioma after treatment," said Thomas Hope, Vice Chair of Radiology and Biomedical Imaging at University of California, San Francisco.

TLX101-Px targets membrane transport proteins called L-type amino acid transporters. The imaging agent is intended to work alongside Telix's therapy candidate TLX101-Tx, currently under investigation in a pivotal trial for patients with recurrent glioblastoma.

Telix's fiscal year 2026 financial guidance does not include revenue contributions from TLX101-Px. The Melbourne-based biopharmaceutical company focuses on developing radiopharmaceuticals for oncology and rare diseases, with operations in multiple countries including the United States, United Kingdom, and Japan.

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