Telix Faces Regulatory Setback as FDA Requests More Data on Brain Cancer Imaging Agent

April 28, 2025 11:54 AM AEST | By Team Kalkine Media

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Telix Faces Regulatory Setback as FDA Requests More Data on Brain Cancer Imaging Agent — Image source: shutterstock

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Highlights

Telix faces regulatory setback on brain cancer imaging agent

FDA requests more clinical evidence for approval

Company plans swift resubmission after addressing feedback

Shares of Telix Pharmaceuticals (ASX:TLX) fell nearly 6% on Monday after the US Food and Drug Administration (FDA) did not approve the company's new drug application (NDA) for TLX101-CDx. The imaging agent was designed to assist in the management of glioma, a form of brain cancer.

The FDA decision was based on the need for additional confirmatory clinical evidence before the drug can move forward. Telix (TLX) promptly responded, stating that it intends to request a hearing to review the regulator's decision and to provide the necessary supporting data.

Christian Behrenbruch, Group Chief Executive of Telix (TLX), emphasized the company's commitment to overcoming this hurdle. He noted that Telix is already running active clinical programs that are expected to supply the additional evidence requested by the FDA. According to Behrenbruch, the company's immediate priority is to thoroughly understand the FDA’s feedback and strengthen the submission with new data in order to address regulatory concerns efficiently.

While the regulatory setback presents a temporary challenge, Telix (TLX) remains focused on advancing TLX101-CDx towards approval. The company has reiterated its confidence in the potential of the imaging agent and its importance in improving the management of glioma, a condition with significant unmet medical needs.

This situation highlights the often unpredictable path of drug approvals, even for companies with innovative technologies. Investors and industry watchers will be closely following Telix's next steps as it works towards fulfilling the FDA's requirements and resubmitting its application.

Despite the recent share price reaction, Telix (TLX) has a pipeline of other clinical programs under development, which could also provide important catalysts for the company in the future.

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