Telix’s Pixclara Brain Cancer Scan Wins FDA Review With September Decision Date

Telix Pharmaceuticals (ASX: TLX) has secured FDA acceptance of its resubmitted Pixclara NDA, setting an 11 September 2026 PDUFA decision date for the glioma imaging agent that carries both Orphan Drug and Fast Track designations.

• The FDA has accepted Telix's resubmitted NDA for Pixclara (TLX101-Px), a PET imaging agent for glioma, with a PDUFA decision date of 11 September 2026.
• Pixclara holds both Orphan Drug and Fast Track designations, reflecting FDA recognition of the unmet need in brain cancer imaging and supporting an expedited review timeline.
• 18F-FET imaging is already embedded in international clinical practice guidelines including NCCN Guidelines, meaning Pixclara addresses a validated global standard of care currently unavailable to US patients.
• Telix's FY 2026 financial guidance excludes any Pixclara revenue contribution, meaning approval and commercialisation would represent pure upside to current forecasts.
• Pixclara is designed to complement the therapeutic candidate TLX101-Tx, forming a theranostic pair that could enable patient selection for the IPAX-BrIGHT pivotal trial in recurrent glioblastoma.