Telix Pharmaceuticals Ltd (ASX: TLX) shares are on the slide on Monday morning.
At the time of writing, the ASX healthcare stock is down 2.5% to $11.03.
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Why are Telix Pharmaceuticals shares falling today?
Investors have been selling the company's shares today after it announced the resubmission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its brain cancer imaging candidate TLX101-Px, also known as Pixclara.
According to the release, the NDA relates to an investigational PET imaging agent designed to help characterise recurrent or progressive glioma, a form of brain cancer, in both adult and paediatric patients.
Telix advised that the application has been resubmitted with additional data requested by the FDA. The company believes the new data and statistical analysis, together with the original submission, address the issues raised in the regulator's earlier Complete Response Letter.
The imaging candidate has already received both Orphan Drug and Fast Track designations from the FDA, reflecting its potential to address a significant unmet medical need.
Importantly, management highlights that while PET imaging with the tracer is already included in international clinical guidelines for imaging gliomas, there is currently no FDA-approved targeted amino acid PET imaging agent commercially available in the United States for brain cancer imaging.
Potential companion diagnostic
Telix also noted that TLX101-Px may serve as a companion diagnostic for its therapeutic candidate TLX101-Tx, which is being investigated as a treatment for glioblastoma in the IPAX-BrIGHT study.
Gliomas are among the most common types of brain tumours, accounting for around 30% of all brain and central nervous system tumours and approximately 80% of malignant brain tumours.
Commenting on the resubmission, Telix's chief medical officer, Dr David N. Cade, said:
We appreciate the FDA's recognition of the critical unmet need to improve the diagnosis and management of glioma, particularly in the posttreatment 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.
Also commenting on the news was Maggie Haynes, who is executive director at Head for the Cure Foundation. Hayne added:
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.
