Pixclara (floretyrosine F 18; 18F-FET)
PET imaging of glioma · Adult and pediatric patients undergoing characterization of recurrent or progressive glioma from treatment-related changes
TLX · Telix Pharmaceuticals Ltd
Regulatory designations
Full timeline
5 milestonesFDA decision expected
FDA assigned a September 11, 2026 PDUFA goal date to the resubmitted Pixclara NDA.
Telix — FDA acceptance and PDUFA goal date↗FDA accepted the resubmitted NDA
FDA accepted the Pixclara NDA resubmission for review and established the new review-cycle goal date.
Telix — FDA acceptance and PDUFA goal date↗Telix resubmitted the NDA
Telix resubmitted the application with additional data and statistical analyses intended to address the prior Complete Response Letter.
Telix — Pixclara NDA resubmission↗Telix described the agreed resubmission pathway
After a Type A meeting, Telix said FDA requested an additional confirmatory efficacy analysis of existing data for the resubmission package.
Telix — Agreement with FDA on resubmission pathway↗Related News
FDA Approves Telix’s Brain Cancer Imaging Drug Pixclara
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Sep 1, 2026Telix Completes Enrollment in Phase 3 BiPASS Study, Aligns with FDA on NDA Pathway
Aug 31, 2026Telix Appoints David Gill as Chair
Aug 20, 2026Telix 2026 Half-Year Results: Strong Commercial Execution and Momentum in Late-Stage Pipeline