Telix Pharmaceuticals has reached agreement with the US Food and Drug Administration (FDA) on a pathway to resubmit its new drug application (NDA) for Pixclara (TLX101-CDx, Floretyrosine F18, 18F-FET), an investigational imaging agent for glioma, a rare and life-threatening form of brain cancer.

The company said it plans to resubmit the NDA in the fourth quarter of 2025. Pixclara is designed to improve the detection and diagnosis of glioma, which can be difficult to identify accurately using conventional imaging.

Following a Type A meeting with the FDA, Telix received detailed feedback on a resubmission package. This will include an additional confirmatory efficacy analysis of existing study data, aimed at addressing review issues raised in the complete response letter (CRL) issued during the agency’s initial review. The additional analysis is intended to provide further evidence of the drug’s utility in accurately imaging glioma lesions, supporting its potential use in clinical practice.

David Cade, group chief medical officer at Telix, said: “As previously advised, Telix had multiple options for delivering additional data requested by the FDA in the CRL response. This flexibility has enabled us to work with relative speed to reach a mutually agreed path forward for resubmission of the NDA. We remain steadfastly focused on our goal of bringing this important imaging agent to patients in the US to support improved diagnosis and management of glioma.”

Telix said the agreement with the FDA allows the company to plan its resubmission timeline with greater certainty, while continuing to engage with stakeholders in the oncology community. Glioma is a rare and aggressive brain cancer that can be difficult to detect early, and imaging agents such as Pixclara may provide clinicians with more precise tools to evaluate disease extent and monitor treatment response.

The NDA resubmission represents a key step in Telix’s broader strategy to advance targeted imaging and radiopharmaceuticals for oncology indications. By following the FDA’s guidance, Telix aims to provide regulators with robust confirmatory data while maintaining the company’s commitment to timely access for patients.

If approved, Pixclara could become an important diagnostic tool for clinicians managing glioma, complementing existing imaging techniques and potentially improving treatment planning and patient outcomes. The company said it will continue to provide updates on regulatory progress and data presentation in scientific forums as the resubmission process advances.