Telix Pharmaceuticals Ltd ADR (NASDAQ:TLX) saw its stock plummet 19% in premarket trading Thursday following the announcement that the U.S. Food and Drug Administration issued a Complete Response Letter (CRL) for its investigational PET imaging agent, TLX250-CDx.
The FDA highlighted issues in the Chemistry, Manufacturing, and Controls (CMC) section of the TLX250-CDx (Zircaix) application, which is designed to detect and characterize renal masses as clear cell renal cell carcinoma. Regulators requested additional data to confirm comparability between the product used in clinical trials and the scaled-up manufacturing process planned for commercial production.
The agency also noted deficiencies in documentation from two third-party manufacturing and supply partners, which must be resolved before Telix can resubmit its application.
Telix stated it believes the issues are “readily addressable” and intends to begin remediation work immediately. The company plans to request a Type A meeting with the FDA to review the deficiencies and establish a resubmission timeline.
Despite the regulatory setback, TLX250-CDx retains its Breakthrough Therapy designation and Priority Review status, underscoring its potential to meet an unmet need in kidney cancer diagnosis.
Dr. Christian Behrenbruch, Managing Director and Group CEO of Telix, emphasized the innovative nature of the product: “TLX250-CDx breaks new ground as a highly novel biologic-based PET imaging agent using a first-in-class isotope.”
The company also confirmed that the delay does not affect its 2025 revenue guidance, as projections did not include revenue from unapproved products. Telix plans to continue patient access to TLX250-CDx through an FDA-approved expanded access program, pending consultation with regulators.
Telix Pharmaceuticals stock price
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