Workflow
FDA rejection
icon
Search documents
Telix (TLX) 4-DAY DEADLINE ALERT: Hagens Berman Urges Telix Investors to Act by Jan. 9 in Class Action Suit Over SEC Subpoena & FDA CRL on Manufacturing Failures
Globenewswire· 2026-01-05 14:09
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, which resulted in significant investor losses [1][2][3]. Regulatory Setbacks - Telix Pharmaceuticals faced regulatory challenges, including an SEC subpoena and a Complete Response Letter (CRL) from the FDA, leading to 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, TLX591 and TLX592, suggesting misleading statements about their advancement [7]. Allegations of Misrepresentation - The lawsuit claims that Telix and its executives overstated the developmental 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 allegedly 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 encouraging affected investors to contact them to discuss their rights and potential recovery options [4][5].