Telix’s TLX101-Px NDA Accepted by FDA with September 11 PDUFA Goal
FDA accepted Telix’s NDA for TLX101-Px, an 18F-FET PET imaging agent for recurrent glioma, assigning a PDUFA goal date of September 11, 2026. The candidate holds Orphan Drug and Fast Track designations, addressing a significant unmet need in distinguishing tumor progression from treatment-related changes.
1. FDA Accepts NDA Resubmission for TLX101-Px
The FDA has accepted Telix’s resubmitted New Drug Application for TLX101-Px (Pixclara), an investigational PET imaging agent using 18F-FET for characterizing recurrent or progressive glioma in both adult and pediatric patients.
2. Designations Granted
TLX101-Px has received Orphan Drug and Fast Track designations from the FDA, underscoring its potential to fulfill a significant unmet need in differentiating true tumor progression from treatment-related changes.
3. PDUFA Date and Regulatory Pathway
The FDA assigned a PDUFA goal date of September 11, 2026, marking the target for regulatory decision and allowing Telix to engage closely with the agency to expedite review and potential approval.
4. Impact on Pipeline and Guidance
Telix’s FY2026 financial guidance currently excludes any revenue from TLX101-Px, but the imaging agent could later support patient selection and response assessment alongside its LAT1-targeting therapy candidate TLX101-Tx.