Core Insights - Telix Pharmaceuticals Limited experienced a significant decline in the price of its American Depositary Shares (ADS), falling approximately 16% after the FDA requested additional data for its kidney cancer detection drug [1] - The company had previously faced a 10% drop in ADS price following the announcement of a subpoena from the SEC regarding its disclosures related to prostate cancer therapeutic candidates [1][3] Company Developments - On August 28, 2025, Telix received a Complete Response Letter (CRL) from the FDA for its Biologics License Application for Zircaix, which is intended for diagnosing clear cell renal cell carcinoma [3] - The CRL highlighted deficiencies in chemistry, manufacturing, and controls, and requested further data to establish comparability between the drug product used in clinical trials and the intended commercial manufacturing process [3] - The FDA also issued notices of deficiency to Telix's third-party manufacturing and supply chain partners, which need to be addressed [3] Legal and Investigative Actions - Hagens Berman, a national shareholders rights firm, is investigating whether Telix misled investors regarding its drug candidates and their development [2][4] - The investigation is particularly focused on the company's statements about its prostate cancer therapeutic candidates and the kidney cancer detection drug [2][4] - Investors who have suffered substantial losses are encouraged to submit their losses to assist in the investigation [2][4]
Telix Pharmaceuticals Limited (TLX) Hits Another Roadblock After SEC Subpoena, Shares Fall Again – Hagens Berman