Telix Sued by Investors Over Prostate Therapy Claims After SEC Subpoena and FDA Rejection

Overview

• The case, Thomas v. Telix Pharmaceuticals Ltd., No. 1:25-cv-02299, was filed in the Southern District of Indiana on behalf of investors who bought Telix securities from Feb. 21 to Aug. 28, 2025.
• The complaint alleges Telix overstated progress on prostate cancer candidates TLX591 and TLX592 and overstated the reliability of its manufacturing and supply chain partners.
• Telix disclosed on July 22, 2025 that it received an SEC subpoena seeking documents about its disclosures on prostate therapeutics, after which the ADSs fell more than 13% over two sessions, according to the filings.
• On Aug. 28, 2025 the company reported an FDA Complete Response Letter for the TLX250‑CDx/Zircaix BLA citing CMC deficiencies and Form 483 observations at two third‑party manufacturers, and the ADSs fell more than 21% over two sessions.
• Investor-rights firms including Faruqi & Faruqi, Bronstein Gewirtz & Grossman, and Hagens Berman are soliciting shareholders and highlighting the Jan. 9, 2026 deadline to seek lead‑plaintiff status.