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·2025-12-25 17:00

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, with a lead plaintiff deadline set for January 9, 2026 [1][6]. Regulatory Setbacks - Telix has faced significant regulatory challenges, 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 prostate cancer therapeutic candidates, suggesting potential misleading statements [7]. Allegations of Misrepresentation - The lawsuit claims that Telix and its executives overstated the progress of their therapeutic candidates and misrepresented the reliability of their 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 has reportedly caused significant financial losses for investors who purchased Telix ADSs during the Class Period from February 21, 2025, to August 28, 2025 [7]. - The firm representing the investors, Hagens Berman, is actively advising those who suffered losses due to undisclosed flaws in the supply chain and therapeutic progress [5][4].