Precision Medicine Portfolio Update
| Stock | TELIX Pharmaceuticals Ltd (TLX.ASX) |
|---|---|
| Release Time | 22 Dec 2025, 8:31 a.m. |
| Price Sensitive | Yes |
Telix Provides Precision Medicine Portfolio Update
- Positive Phase 3 data for Illuccix in China, enabling NDA submission
- FDA resubmission progress for TLX101-CDx and TLX250-CDx
- Continued commitment to serving patients through expanded access programs
Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX) today provided a precision medicine portfolio update, highlighting positive data from the Phase 3 study of TLX591-CDx (Illuccix) in Chinese patients, as well as progress on FDA resubmissions for TLX101-CDx and TLX250-CDx. The Illuccix China Phase 3 study met its primary endpoint, demonstrating a strong positive predictive value (PPV) of 94.8% for the detection of tumors in patients with biochemical recurrence of prostate cancer. The high PPV was consistent across different metastatic locations and even in patients with very low PSA levels, confirming the broad clinical applicability of Illuccix in the Chinese market. Telix plans to submit a New Drug Application for Illuccix in China based on these compelling data. The company also provided updates on its FDA resubmission efforts for TLX101-CDx and TLX250-CDx. For TLX101-CDx, Telix has had collaborative interactions with the FDA and is finalizing its resubmission package. For TLX250-CDx, Telix has reached alignment with the FDA on the remediation of identified chemistry, manufacturing, and controls (CMC) deficiencies, and will provide a further update following an additional meeting in January. Telix's commitment to serving patients is reflected in the continued operation of expanded access programs for both TLX101-CDx and TLX250-CDx.
Telix is focused on advancing its precision medicine portfolio, with plans to submit NDAs for Illuccix in China and continue the FDA resubmission process for TLX101-CDx and TLX250-CDx. The company remains committed to serving patients through its expanded access programs.