Telix Pharmaceuticals Limited: Precision Medicine Portfolio Update

Telix Pharmaceuticals Limited has announced a significant update on its precision medicine portfolio, with positive developments regarding three key products. The Phase 3 study for TLX591-CDx (Illuccix) in China met its primary endpoint, showing high positive predictive value for prostate cancer imaging in Chinese patients. This data will form the basis for a near-term New Drug Application (NDA) submission in China. Additionally, Telix is progressing with the resubmission of its NDA for TLX101-CDx (Pixclara), a PET imaging candidate for glioma, to the FDA, following collaborative interactions and a productive Type A meeting. The company also had a positive Type A meeting with the FDA regarding TLX250-CDx (Zircaix), a PET imaging candidate for ccRCC, to address deficiencies in the Chemistry, Manufacturing, and Controls (CMC) package. Telix is finalizing resubmission plans for TLX101-CDx and expects to provide further updates on FDA acceptance. For TLX250-CDx, alignment was reached with the FDA on remediation, with an additional meeting scheduled for January to review data for commercial manufacturing processes. Expanded Access Programs for both TLX101-CDx and TLX250-CDx remain active.