Telix stock plunges after FDA issues Complete Response Letter

Investing.com -- Telix Pharmaceuticals Ltd ADR (NASDAQ:TLX) shares tumbled 19% Thursday premarket after the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its investigational PET imaging agent TLX250-CDx.

The FDA identified deficiencies in the Chemistry, Manufacturing, and Controls package for TLX250-CDx (Zircaix), which is designed to diagnose and characterize renal masses as clear cell renal cell carcinoma. Regulators requested additional data to establish comparability between the drug product used in clinical trials and the scaled-up manufacturing process intended for commercial use.

The agency also documented notices of deficiency issued to two third-party manufacturing and supply chain partners that will require remediation before Telix can resubmit its application.

Telix stated it believes these concerns are "readily addressable" and plans to begin remediation immediately. The company will request a Type A meeting with the FDA to address the deficiencies and determine a timeframe for resubmission.

Despite the setback, the company noted that TLX250-CDx maintains its Breakthrough Therapy designation and Priority Review status, reflecting its potential to address an unmet medical need in kidney cancer diagnosis.

Dr. Christian Behrenbruch, Managing Director and Group CEO of Telix, emphasized the novel nature of the product, stating, "TLX250-CDx breaks new ground as a highly novel biologic-based PET imaging agent using a first-in-class isotope."

The company confirmed that the regulatory delay does not impact its 2025 revenue guidance, as forecasts excluded revenue from unapproved products. Telix intends to continue providing patient access to TLX250-CDx through an FDA-approved expanded access program, pending consultation with regulators.

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