Telix Resubmits Brain Cancer Imaging Drug to FDA

Telix Pharmaceuticals seeks approval for TLX101-Px, a PET imaging agent for recurrent or progressive glioma.

Mar. 15, 2026 at 9:48pm

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Telix Pharmaceuticals Limited has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TLX101-Px, an investigational PET imaging agent for characterizing recurrent or progressive glioma (brain cancer) from treatment-related changes in both adult and pediatric patients. The company believes the additional data and analysis provided in the resubmission appropriately addresses the FDA's previous Complete Response Letter.

Why it matters

TLX101-Px has been granted Orphan Drug and Fast Track designations by the FDA, recognizing the significant unmet medical need for improved brain cancer imaging options. Currently, there is no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.S.

The details

Telix's resubmission is supported by an extensive data set, particularly important for an orphan indication like glioma. The PET imaging agent targets membrane transport proteins LAT1 and LAT2, enabling it to potentially be used as a companion diagnostic for Telix's glioblastoma therapy candidate TLX101-Tx, which is currently under investigation.

  • Telix resubmitted the NDA in March 2026.

The players

Telix Pharmaceuticals Limited

A global biopharmaceutical company focused on developing therapeutic and diagnostic radiopharmaceuticals, with the goal of addressing significant unmet medical needs in oncology and rare diseases.

Dr. David N. Cade

Telix Group Chief Medical Officer.

Maggie Haynes

Executive Director, Head for the Cure Foundation.

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What they’re saying

“We appreciate the FDA's recognition of the critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting. Our resubmission is supported by an extensive and compelling data set – particularly so for an orphan indication.”

— Dr. David N. Cade, Telix Group Chief Medical Officer (Globe Newswire)

“Our community is encouraged by the FDA's ongoing engagement and guidance to the sponsor and support for the Expanded Access Program for TLX101-Px. We are hopeful of an expedited review, so this important and proven imaging option can become available to those who urgently need it.”

— Maggie Haynes, Executive Director, Head for the Cure Foundation (Globe Newswire)

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