TELIX Pharmaceuticals Limited (NASDAQ: TLX) saw its stock climb 1.9% in after-hours trading on Tuesday after the company disclosed that it had lodged a marketing authorization application, or MAA, in Europe for its brain cancer imaging product candidate.
The Australian-based radiopharmaceutical firm is seeking regulatory clearance for TLX101-Px, a positron emission tomography, or PET, imaging agent developed to help clinicians distinguish progressive or recurrent glioma from treatment-related changes in both adult and pediatric patients. The submission targets major European markets and is intended to provide broader patient access to advanced brain imaging through a clinical label that the company says aligns with current clinical practice guidelines.
At present in Europe, PET imaging of glioma with 18F-FET - the active component of TLX101-Px - is carried out under physician-supervised use and relies on hospital-based production at a limited number of sites. Telix has framed the MAA as a move to address the absence of a generally available commercial product that would offer more consistent quality and wider access across treatment centers.
Commenting on the submission, Kevin Richardson, Chief Executive Officer of Telix Precision Medicine, said: "We see a compelling opportunity in Europe to broaden access to authorized targeted radiopharmaceuticals for brain cancer imaging and therapy, and as such this submission is an important milestone for Telix."
The company is coordinating regulatory preparation for both European and U.S. authorities in parallel. Telix advanced the European filing while aligning elements of that dossier with the package it is assembling for the U.S. Food and Drug Administration. According to the company, the European MAA will be followed by a New Drug Application submission in the United States.
Beyond diagnostic use, TLX101-Px is being developed as a patient selection and response assessment tool for Telix's glioblastoma therapy candidate, TLX101-Tx. That therapeutic candidate holds orphan drug designation in both Europe and the U.S. and is currently the subject of the Phase 3 IPAX-BrIGHT trial in patients with recurrent glioblastoma.
The announcement and the subsequent after-hours share move reflect Telix's effort to transition an imaging approach that has been largely confined to hospital-based, physician-supervised production toward a commercially authorized product that the company believes could standardize access and quality across European treatment centers.