Telix Receives Second FDA Rejection for Kidney Cancer Drug, Plans to Address Deficiencies

Telix Pharmaceuticals has received a Complete Response Letter from the FDA for its Biologics License Application for TLX250-CDx, an investigational PET2 agent for kidney cancer diagnosis and characterization. The FDA has requested additional data on the drug's manufacturing process and has documented notices of deficiency for two third-party manufacturing and supply chain partners. Telix plans to request a Type A meeting with the FDA and continue providing patient access to TLX250-CDx through an FDA-approved expanded access program.

Telix Pharmaceuticals Limited (TLX) has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA) for TLX250-CDx, an investigational PET2 agent for kidney cancer diagnosis and characterization. The FDA has requested additional data on the drug's manufacturing process and has documented notices of deficiency for two third-party manufacturing and supply chain partners.

The CRL identifies deficiencies in the Chemistry, Manufacturing, and Controls (CMC) package, which includes the drug product used in the ZIRCON Phase 3 clinical trial and the scaled-up manufacturing process intended for commercial use. The FDA has also requested additional data to establish comparability between the two processes.

Telix plans to request a Type A meeting with the FDA to address these deficiencies and determine an appropriate timeframe for resubmission. The company believes these concerns are readily addressable and submission remediation will begin immediately. According to Reuters, if approved, TLX250-CDx would be the first PET scan-based drug specifically designed for kidney cancer in the U.S.

The CRL does not impact Telix's stated revenue guidance for 2025. The company intends to continue providing patient access to TLX250-CDx through the FDA-approved expanded access program (EAP), subject to consultation with the FDA.

Analysts have noted that the delay in approval may negatively affect investors' sentiment on Telix management's regulatory execution and its ability to navigate the complex CMC and logistics of the radiopharmaceutical industry. However, the Zircaix franchise is seen as a key growth lever for Telix, helping diversify beyond its core PSMA PET imaging business.

References:
[1] https://www.urologytimes.com/view/fda-issues-complete-response-letter-for-89zr-dfo-girentuximab-in-ccrcc
[2] https://www.benzinga.com/analyst-stock-ratings/analyst-color/25/08/47394179/telix-gets-second-fda-rejection-for-kidney-cancer-drug