• Received Complete Response Letter from FDA for TLX250-CDx BLA
• Deficiencies relate to Chemistry, Manufacturing, and Controls (CMC)
• FDA requests additional data to establish comparability between trial and commercial drug product
• Issues with third-party manufacturing and supply chain partners require remediation

Telix Pharmaceuticals Limited announced that it has received a Complete Response Letter (CRL) from the United States Food and Drug Administration (FDA) for the Biologics License Application (BLA) for TLX250-CDx (Zircoix®, 89Zr-DFO-girentuximab), an investigational PET agent for the diagnosis and characterization of renal masses as clear cell renal cell carcinoma. The CRL identifies deficiencies relating to the Chemistry, Manufacturing, and Controls (CMC) package. The FDA has requested additional data to establish comparability between the drug product used in the ZIRCON Phase 3 clinical trial and the scaled-up manufacturing process intended for commercial use. Additionally, the FDA has documented notices of deficiency (Form 483) issued to two third-party manufacturing and supply chain partners that will require remediation prior to resubmission. Telix believes these concerns are readily addressable and submission remediation will begin immediately. The Company will request a Type A meeting with the FDA as soon as practicable to address the deficiencies and determine an appropriate timeframe for resubmission. TLX250-CDx has a Breakthrough Therapy designation and Priority Review status, acknowledging its importance in addressing a significant unmet medical need and clinically demonstrating benefit over available diagnostics.

Telix believes the outstanding matters are resolvable and that it can address the remaining FDA requests within a reasonable time frame. The Company intends to continue to provide patient access to TLX250-CDx through the FDA-approved expanded access program, subject to consultation with the FDA.