Telix Resubmits NDA to U.S. FDA for Brain Cancer Imaging Candidate

The company believes the additional data and analysis address the FDA's previous concerns.

Mar. 15, 2026 at 10:12pm

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Telix Pharmaceuticals Limited has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational PET imaging agent TLX101-Px (Pixclara®) for the characterization of recurrent or progressive glioma (brain cancer) from treatment-related changes in both adult and pediatric patients. The company believes the additional data and statistical analysis, along with the primary data set provided in the original submission, appropriately address 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 has resubmitted the NDA with the additional data requested by the FDA. PET imaging with 18 F-FET is already included in international clinical practice guidelines for the imaging of gliomas, but this agent has not yet been approved by the FDA. TLX101-Px targets membrane transport proteins known as LAT1 and LAT2, enabling it to potentially be utilized as a companion diagnostic agent to Telix's LAT1-targeting glioblastoma (GBM) 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 the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies.

U.S. Food and Drug Administration (FDA)

The federal agency responsible for regulating and supervising the safety of food, drugs, and other products in the United States.

TLX101-Px (Pixclara®)

Telix's investigational PET imaging agent for the characterization of recurrent or progressive glioma (brain cancer) from treatment-related changes.

TLX101-Tx

Telix's LAT1-targeting glioblastoma (GBM) therapy candidate, currently under investigation in the pivotal IPAX-BrIGHT study.

Maggie Haynes

Executive Director of the 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. We are grateful to our global clinical collaborators, who share our commitment to ensuring patients in the U.S. can benefit from this important patient management tool.”

— 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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