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News  ›  GlobeNewswire Inc.

Precision Medicine Portfolio Update: Illuccix China Phase 3 Study, TLX101-CDx and TLX250-CDx FDA Resubmissions

GlobeNewswire Inc. Logo GlobeNewswire Inc. By Telix Pharmaceuticals Limited
Precision Medicine Portfolio Update: Illuccix China Phase 3 Study, TLX101-CDx and TLX250-CDx FDA Resubmissions

Telix Pharmaceuticals announced positive Phase 3 results for TLX591-CDx (Illuccix) in Chinese prostate cancer patients with a 94.8% positive predictive value, enabling near-term NDA submission in China. The company is also progressing with FDA resubmissions for TLX101-CDx (glioma imaging) and TLX250-CDx (renal cancer imaging), with collaborative meetings held to address manufacturing and control deficiencies.

Insights
TLX   positive

Company achieved positive Phase 3 results for Illuccix in China with strong efficacy metrics (94.8% PPV), enabling regulatory submission in a strategically important market. FDA resubmissions for two additional candidates are progressing with collaborative alignment on remediation of deficiencies, indicating constructive regulatory engagement and pathway forward for multiple pipeline assets.