Core Viewpoint - Telix Pharmaceuticals Ltd. is facing a securities class action lawsuit due to alleged misstatements regarding the progress of its prostate cancer drug TLX591 and deficiencies in its third-party manufacturing processes, leading to significant investor losses [2][3]. Regulatory Issues - The lawsuit follows regulatory setbacks, including an SEC subpoena and a Complete Response Letter (CRL) from the FDA, which resulted in a 21% decline in stock value [2][7]. - The SEC is investigating the company's disclosures related to the development of its therapeutic candidates, suggesting misleading statements about their advancement [7]. - The FDA rejected the Zircaix application, citing severe deficiencies in Chemistry, Manufacturing, and Controls (CMC), and issued Form 483 notices to two third-party supply chain partners, revealing foundational weaknesses that were allegedly concealed [7]. Allegations of Misstatements - The complaint alleges that Telix and its executives materially overstated the developmental progress of its therapeutic candidates and misrepresented the reliability and regulatory compliance of its third-party supply chain and manufacturing partners [2][3]. - Documented failures in regulatory compliance were allegedly concealed, making the company's claims of "great progress" and "truly global manufacturing capability" materially false [3]. Investor Impact - The cumulative effect of the regulatory disclosures led to a sharp decline in Telix ADSs, with a notable 21% drop following the final regulatory news, resulting in significant damages for investors who purchased TLX ADSs during the Class Period from February 21, 2025, to August 28, 2025 [7].