FDA sets PDUFA date for Telix’s TLX101-Px glioma imaging

On April 9, 2026, the U.S. FDA accepted Telix Pharmaceuticals’ resubmitted New Drug Application (NDA) for TLX101-Px (Pixclara, floretyrosine F 18), an investigational PET imaging agent for glioma in adult and pediatric patients. The agency assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 11, 2026.

Mechanism and evidence

TLX101-Px is a PET imaging agent designed to identify active glioma tissue and help distinguish tumor progression from treatment-related changes.

The NDA resubmission follows prior FDA Orphan Drug and Fast Track designations for TLX101-Px, reflecting its development for use in glioma imaging.

Commercial and programme context

Telix Pharmaceuticals is advancing TLX101-Px as a diagnostic companion to its LAT1-targeting therapy candidate TLX101-Tx, which is currently being evaluated in the pivotal IPAX-BrIGHT trial for recurrent glioblastoma. 

The FDA’s acceptance of the NDA resubmission and assignment of a PDUFA date establishes a regulatory decision point. The development timeline of the diagnostic is therefore aligned with that of its paired therapeutic programme.

What This Means

Current imaging methods, such as contrast-enhanced MRI, remain standard in glioma monitoring, but post-treatment changes can complicate interpretation and create a role for additional diagnostic tools.

Detailed pivotal performance data have not yet been publicly disclosed, placing emphasis on the upcoming regulatory decision as the next point of programme validation.

Source: GlobeNewswire, April 9, 2026, ClinicalTrials.gov (NCT07100730)