Highlights

  • Telix reports positive Phase 3 data for Illuccix prostate imaging study in China.
  • FDA resubmission processes continue for TLX101-CDx and TLX250-CDx imaging candidates.
  • Regulatory discussions progress across China and the United States for diagnostic portfolio.

Telix Pharmaceuticals Limited (ASX:TLX) has released an update on its precision medicine portfolio, outlining developments related to its prostate cancer imaging agent in China and regulatory interactions with the U.S. Food and Drug Administration (FDA) for two diagnostic candidates.

Illuccix Phase 3 Study in China Meets Primary Endpoint

Telix announced positive top-line results from its Phase 3 registration study of TLX591-CDx (Illuccix®), a PSMA-PET imaging agent for prostate cancer, conducted in Chinese patients. The study met its primary endpoint by achieving a patient-level positive predictive value (PPV) of 94.8% for tumor detection in men with biochemical recurrence following prior prostatectomy or radiation therapy.

The open-label, multicenter study enrolled 140 patients and was conducted in collaboration with Grand Pharmaceutical Group Limited, Telix’s commercial partner in Greater China. The lower bound of the 95% confidence interval exceeded the threshold agreed with Chinese regulators, providing the basis for a near-term New Drug Application submission in China.

Region-level analysis showed PPVs of 100% in the prostate bed and extra-pelvic soft tissue and organ metastases, 94.7% in the pelvic region outside the prostate bed, and 87.0% in bone metastases. High PPV was observed across all prostate-specific antigen (PSA) subgroups, including patients with low baseline PSA levels.

The study also reported that 67.2% of participants experienced a change in their treatment plan following PSMA-PET imaging, compared with the initial plan determined at baseline. Final study data is intended for submission to a peer-reviewed journal.

TLX101-CDx FDA Resubmission Nears Completion

Telix provided an update on its New Drug Application resubmission for TLX101-CDx (Pixclara®), a PET imaging candidate for glioma, to the FDA. The company has engaged in collaborative discussions with the regulator, including a Type A meeting to address a previously issued Complete Response Letter.

The resubmission package includes additional clinical data and a revised statistical analysis plan. Telix stated that it will provide a further update once the FDA has accepted the resubmitted application. The Expanded Access Program for TLX101-CDx remains active in the United States.

TLX250-CDx FDA Discussions Focus on Manufacturing

The company also reported progress on TLX250-CDx (Zircaix®), a PET imaging agent for clear cell renal cell carcinoma. Telix recently held a Type A meeting with the FDA to address issues raised in a Complete Response Letter related to chemistry, manufacturing, and controls.

An additional FDA meeting is scheduled for January to review the company’s plan for generating data to demonstrate comparability between the clinical trial material and the scaled-up commercial manufacturing process. The Expanded Access Program for TLX250-CDx continues to operate.

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TLX was trading 0.63% higher at AUD 11.905 per share as of 22 December 2025.