TLX 7-DAY DEADLINE ALERT: Hagens Berman Urges Telix Investors to Act by Jan. 9 Over Alleged Dual Regulatory Failures: SEC Subpoena & FDA CRL on CMC/Supply Chain
Globenewswire·2026-01-02 19:24

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 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 Telix's stock price [2][7]. - The SEC is investigating Telix's disclosures related to the development of its prostate cancer therapeutic candidates, suggesting misleading statements about their advancement [7]. - The FDA rejected Telix's 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 Misrepresentation - 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]. - The complaint claims that these documented failures were material and 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 allegedly caused Telix ADSs to fall sharply, leading to damages for investors who purchased TLX ADSs during the Class Period from February 21, 2025, to August 28, 2025 [7]. - The firm Hagens Berman is urging Telix investors who suffered substantial losses to contact them to discuss their rights [4][5].