Investing.com — stock rose 1.9% in after-hours trading Tuesday following the company’s announcement of a marketing authorization application (MAA) submission in Europe for its brain cancer imaging agent.
The Australian-based radiopharmaceutical company is seeking approval for TLX101-Px, a positron emission tomography (PET) imaging candidate designed to distinguish progressive or recurrent glioma from treatment-related changes in both adult and pediatric patients. The submission covers major European markets and aims to expand patient access to advanced brain imaging through a broad clinical label that reflects current clinical practice guidelines.
Currently in Europe, PET imaging of glioma with 18F-FET (the active component of TLX101-Px) is performed under physician-supervised use through hospital-based production at limited sites. Telix aims to address the lack of a generally available commercial product that ensures consistent quality and access.
“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,” said Kevin Richardson, Chief Executive Officer of Telix Precision Medicine.
The company has been preparing regulatory packages for both European and U.S. markets concurrently, bringing forward the European submission while aligning with aspects of the U.S. Food and Drug Administration package. Telix plans to follow with a New Drug Application submission in the United States.
TLX101-Px is also being developed as a patient selection and response assessment tool for Telix’s glioblastoma therapy candidate TLX101-Tx, which has received orphan drug designation in both Europe and the U.S. and is the subject of the Phase 3 IPAX-BrIGHT trial in patients with recurrent glioblastoma.
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