Telix Doses First Patient in Phase 3 IPAX-BrIGHT Glioblastoma Trial

Telix Pharmaceuticals administered the first dose of TLX101-Tx, a radiopharmaceutical therapy targeting L-type amino acid transporter 1 to cross the blood-brain barrier and deliver treatment directly to glioblastoma tumors, in the global multicenter Phase 3 IPAX-BrIGHT trial. The open-label study compares TLX101-Tx combined with lomustine chemotherapy against chemotherapy alone in patients with radiographically confirmed recurrent glioblastoma at first recurrence. Regulatory approvals support the trial in Australia, Austria, Belgium, and the Netherlands, with further jurisdictions pending. TLX101-Px, an investigational PET imaging agent, aids patient selection and tumor response assessment. Prior trials IPAX-1 and IPAX-Linz showed median overall survival of 13 months and 12.4 months from treatment initiation, respectively, while an early access program in Europe treated 18 patients.

This milestone advances Telix's neuro-oncology pipeline amid limited treatment options for glioblastoma, where only two FDA approvals occurred in 25 years and no standard therapy exists for recurrence. The company reported 56% revenue growth to $804 million over the past twelve months, with market capitalization at $3.73 billion and shares up 43% year-to-date. TLX101-Tx holds orphan drug designations in the U.S. and Europe. Parallel progress includes FDA acceptance of TLX101-Px NDA with a September 11, 2026 PDUFA date and Phase 3 trials in prostate and kidney cancers, positioning Telix to address high unmet needs in oncology radiopharmaceuticals.