FDA Accepts Telix NDA Resubmission for Glioma Imaging Agent Pixclara (TLX101-Px) and Sets PDUFA Date

Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX) announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for TLX101-Px (Pixclara®, Floretyrosine F 18). TLX101-Px is an investigational PET imaging agent designed for the characterization of recurrent or progressive glioma in both adult and pediatric patients. The FDA has assigned a PDUFA goal date of September 11, 2026. The imaging agent targets LAT1 and LAT2 membrane transport proteins and has previously been granted Orphan Drug and Fast Track designations by the FDA. If approved, Pixclara is expected to address a significant unmet medical need by distinguishing tumor progression from treatment-related changes, a major challenge in glioma care. Additionally, the agent serves as a companion diagnostic for Telix’s therapeutic candidate TLX101-Tx, currently in the pivotal IPAX-BrIGHT trial. Telix noted that its FY 2026 financial guidance does not yet include revenue contributions from this product.