Core Viewpoint - The article discusses a securities class action lawsuit against Telix Pharmaceuticals Ltd, alleging that the company and its executives misrepresented the progress of their prostate cancer drug candidates TLX591 and TLX592, as well as the reliability of their third-party manufacturing partners, leading to significant stock declines [1]. Regulatory Failures - On July 22, 2025, Telix disclosed an SEC subpoena related to the development of TLX591 and TLX592, raising questions about misleading disclosures regarding drug development progress [1]. - On August 28, 2025, the FDA issued a Complete Response Letter (CRL) rejecting the Zircaix (TLX250-CDx) application due to deficiencies in Chemistry, Manufacturing, and Controls (CMC), along with documented Form 483 deficiencies at third-party manufacturers [1]. Stock Impact - Following the regulatory revelations, Telix's American Depositary Shares (ADSs) experienced a sharp decline, including a 21% drop after the final regulatory news [1]. - The lawsuit claims that investors who purchased TLX ADSs during the class period (February 21, 2025 – August 28, 2025) may be entitled to damages due to the undisclosed issues [1]. Legal Proceedings - The deadline for investors to move the court for appointment as lead plaintiff in the class action lawsuit is January 9, 2026 [1]. - Hagens Berman, the law firm leading the litigation, is actively advising affected investors and has a history of securing substantial recoveries for investors [1].