Core Viewpoint - Telix Pharmaceuticals Limited received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for TLX250-CDx, indicating deficiencies in the Chemistry, Manufacturing, and Controls (CMC) package [1][2]. Group 1: Regulatory Developments - 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 [2]. - The FDA issued notices of deficiency (Form 483) to two third-party manufacturing and supply chain partners, which will require remediation before resubmission [3]. - The company plans to request a Type A meeting with the FDA to address the deficiencies and establish a timeline for resubmission [3]. Group 2: Financial Implications - The CRL does not affect Telix's revenue guidance for 2025, and the company will continue to provide patient access to TLX250-CDx through the FDA-approved expanded access program [4]. - Analysts noted that the delay in approval could negatively impact investor sentiment regarding Telix's regulatory execution and ability to navigate the complexities of the radiopharmaceutical industry [5]. Group 3: Market Context - If approved, TLX250-CDx would be the first PET scan-based drug specifically designed for kidney cancer in the U.S. [5]. - Without Zircaix, investor focus is expected to remain on the commercial performance of Illuccix and Gozellix [6]. - Following the news, TLX stock experienced a decline of 13.18%, trading at $10.51 [6].
Telix Gets Second FDA Rejection For Kidney Cancer Drug