• Telix reaches agreement with FDA on resubmission of NDA for TLX101-CDx (Pixclara®)
• Additional confirmatory efficacy study analysis of existing data required for resubmission
• FDA has indicated expedited review likely due to unmet medical need

Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX) has announced that it has reached an agreement with the United States (U.S.) Food and Drug Administration (FDA) regarding the resubmission of its New Drug Application (NDA) for TLX101-CDx (Floretyrosine F18 or 18F-FET, Pixclara®), an investigational agent for the imaging of glioma, a rare and life-threatening brain cancer. Following engagement with the FDA, including a successful Type A meeting, Telix has received detailed feedback regarding a resubmission package which will include an additional confirmatory efficacy study analysis of existing data. Based on this feedback, Telix believes the study will meet the FDA's request for additional confirmatory evidence to supplement the NDA and address the review matters cited in the Complete Response Letter (CRL). The FDA has acknowledged the unmet medical need and has indicated that an expedited review is likely to be granted on this basis, subject to submission review. TLX101-CDx is not included in Telix's stated revenue guidance for 2025, as guidance excludes revenue forecasts from unapproved products. The Company remains committed to providing ongoing patient access to TLX101-CDx through the FDA-approved expanded access program (EAP) up until U.S. regulatory approval.

Telix's stated revenue guidance for 2025 excludes revenue forecasts from unapproved products, including TLX101-CDx.