The FDA has accepted Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px (Pixclara), its radiolabeled glioma imaging agent, with a Sept. 11, 2026 PDUFA date. The program targets characterization of progressive or recurrent glioma across adult and pediatric populations. Acceptance for review following resubmission indicates the agency has cleared threshold administrative and substantive review requirements to move the package into a formal decision timeline. The assigned PDUFA date provides a key near-term catalyst for investors and clinical stakeholders awaiting imaging expansion. If approved, Pixclara would add to the molecular imaging toolset used to evaluate glioma progression and support treatment planning decisions.