Telix Faces FDA Hurdles but Advances Resubmissions for Key Imaging Agents

Illuccix Phase 3 Success in China

Telix Pharmaceuticals has announced encouraging top-line results from its Phase 3 registration study of Illuccix (TLX591-CDx) in Chinese patients with biochemical recurrence of prostate cancer. The study, conducted in partnership with Grand Pharmaceutical Group Limited, demonstrated a patient-level positive predictive value (PPV) of 94.8%, surpassing regulatory expectations. This robust performance was consistent across various metastatic sites and PSA levels, including very low PSA values, underscoring the agent's broad clinical utility.

Importantly, the imaging results influenced clinical decision-making, with over two-thirds of patients experiencing changes to their treatment plans. This suggests Illuccix could significantly improve personalized management of prostate cancer in China, a market with rapidly growing prostate cancer incidence and expanding nuclear medicine infrastructure.

Progress on FDA Resubmissions for TLX101-CDx and TLX250-CDx

Beyond China, Telix is advancing regulatory efforts in the United States for two other PET imaging candidates. For TLX101-CDx (Pixclara), a glioma imaging agent, the company is finalizing its New Drug Application resubmission after productive discussions with the FDA, including additional clinical data and revised statistical analyses. An update on FDA acceptance of this resubmission is expected soon.

Similarly, for TLX250-CDx (Zircaix), targeting clear cell renal cell carcinoma, Telix has reached alignment with the FDA on addressing chemistry, manufacturing, and controls (CMC) deficiencies that led to a Complete Response Letter. A follow-up FDA meeting is scheduled to review plans for demonstrating comparability between clinical trial and commercial manufacturing processes. Both candidates continue to be available to patients through active Expanded Access Programs, reflecting Telix’s commitment to patient care during regulatory review.

Strategic Implications and Market Outlook

Telix’s positive Illuccix data in China positions the company to submit a New Drug Application imminently in a strategically important and fast-growing market. The strong clinical validation of Illuccix’s diagnostic accuracy and impact on treatment decisions could accelerate adoption and reimbursement. Meanwhile, progress with the FDA on TLX101-CDx and TLX250-CDx resubmissions signals potential for future approvals in the U.S., expanding Telix’s footprint in precision oncology imaging.

As the company navigates these regulatory milestones, investors and stakeholders will be watching closely for formal submissions, FDA acceptance updates, and peer-reviewed publications of the Illuccix data. These developments will be critical to Telix’s growth trajectory and its role in advancing radiopharmaceutical diagnostics globally.