TLX CLASS ACTION DEADLINE: Hagens Berman Urges Telix Investors to Act by Jan. 9 Over Alleged Dual Regulatory Failures: SEC Subpoena & FDA CRL on CMC/Supply Chain
Globenewswire·2025-12-31 19:01

Core Viewpoint - The article highlights a pending securities class action lawsuit against Telix Pharmaceuticals Ltd. due to alleged misstatements regarding the company's therapeutic candidates and supply chain reliability, leading to significant investor losses [1][2][3]. Regulatory Setbacks - Telix faced multiple regulatory challenges, including an SEC subpoena and a Complete Response Letter (CRL) from the FDA, which resulted in a 21% decline in stock value following the final news [2][7]. - The SEC is investigating the company's disclosures related to the development of its prostate cancer therapeutic candidates, suggesting misleading statements about their advancement [7]. Allegations of Misrepresentation - The lawsuit claims that Telix and its executives overstated the developmental progress of its therapeutic candidates and misrepresented the reliability of its third-party supply chain and manufacturing partners [2][3]. - The complaint alleges that the SEC questioned the development disclosures, while the FDA rejected a Biologics License Application (BLA) due to deficiencies in Chemistry, Manufacturing, and Controls (CMC) [3][7]. Investor Impact - The cumulative effect of the regulatory disclosures reportedly caused significant financial damage to investors who purchased Telix ADSs during the Class Period from February 21, 2025, to August 28, 2025 [7]. - The firm Hagens Berman is actively advising investors who suffered substantial losses due to undisclosed flaws in the supply chain and therapeutic progress [5][6].