Telix Pharmaceuticals (ASX:TLX) has submitted a Marketing Authorisation Application in Europe for its glioma imaging candidate, TLX101-Px.
The radiopharmaceutical is designed for use with positron emission tomography to provide high-resolution imaging of brain tumours.
While FET-PET imaging is currently recognised in clinical guidelines, it is often restricted to hospital-based production at limited sites.
By securing a formal commercial authorisation, Telix intends to provide a standardised, high-quality product that improves patient access across major European markets.
A key advantage of TLX101-Px is its ability to distinguish between active tumor progression and treatment-related changes, a task where conventional MRI often falls short.
Beyond its diagnostic utility, TLX101-Px serves as a companion diagnostic for Telix’s glioblastoma therapy candidate, TLX101-Tx.
The "theranostic" approach allows clinicians to use the imaging agent for patient selection and to monitor response to therapy in real-time.
The dual-purpose capability is currently being evaluated in the Phase 3 IPAX-LinGHT trial.
Telix confirmed that a New Drug Application in the US is expected to follow shortly, as the company aligns its global regulatory strategy to bring this advanced imaging tool to clinicians and patients worldwide.
At the time of reporting, Telix Pharmaceuticals' share price was $8.87.