NewTimeSpace News:On March 16, 2026, Telix announced via a corporate announcement the resubmission of a New Drug Application (NDA) to the U.S. FDA for TLX101-Px (Pixclara®), full name Floretyrosine F 18 (18F-FET), an investigational PET imaging agent for brain cancer (glioma) imaging.

The announcement stated that the resubmission was completed after supplementing the relevant data as requested by the FDA. Telix indicated that based on a Type A meeting and ongoing consultations with the FDA, the supplemented data and statistical analysis, combined with the primary dataset from the original submission, have appropriately addressed the Complete Response Letter previously issued by the FDA, demonstrating strong potential for approval.

According to the announcement, TLX101-Px has been awarded Orphan Drug and Fast Track designations by the FDA due to its potential to address significant unmet medical needs in the diagnosis and treatment of glioma. At present, 18F-FET PET imaging has been included in international clinical practice guidelines for glioma imaging, yet there is no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.S. market.

Dr. David N. Cade, Group Chief Medical Officer of Telix, stated that the resubmitted application is supported by an extensive and compelling dataset, particularly for the orphan indication.

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