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FDA Accepts Telix’s NDA for Glioma Imaging Agent TLX101-Px with September Review Target
8:36am on Friday 10th of April, 2026 AEST
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Healthcare
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FDA Accepts Telix’s NDA for Glioma Imaging Agent TLX101-Px with September Review Target
8:36am on Friday 10th of April, 2026 AEST
Key Points
FDA accepts resubmitted NDA for TLX101-Px with September 2026 PDUFA date
TLX101-Px holds Fast Track and Orphan Drug designations for glioma imaging
Agent targets LAT1 and LAT2 transporters, aiding glioma characterisation
NDA acceptance marks key regulatory milestone but FY 2026 guidance excludes revenue
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Telix Pharmaceuticals (ASX:TLX)
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