Core Viewpoint - Telix Pharmaceuticals Ltd. is facing a securities class action lawsuit due to regulatory setbacks and significant stock declines, with allegations of misleading statements regarding its business operations and therapeutic candidates [1][2][3]. Allegations - The lawsuit claims that Telix overstated the developmental progress and commercial prospects of its prostate cancer therapeutic candidates, specifically TLX591 and TLX592 [3]. - It is alleged that the company misrepresented the stability, quality, and regulatory compliance of its third-party supply chain and manufacturing partners, which were critical to its regulatory applications [4]. Regulatory Events Impacting Stock - The first significant stock decline occurred after Telix disclosed receiving a subpoena from the SEC on July 22, 2025, leading to a more than 13% drop in the price of Telix's American Depositary Shares (ADSs) over two trading sessions [5]. - A more severe decline followed the announcement of a Complete Response Letter (CRL) from the FDA on August 28, 2025, regarding TLX250-CDx (Zircaix), which identified deficiencies in the Chemistry, Manufacturing, and Controls (CMC) package, resulting in a further decline of over 21% in the stock price [6][7]. Investigation - Hagens Berman is actively investigating the claims against Telix, focusing on the discrepancies between the company's long-term assurances and the regulatory revelations that followed [8].
Telix Pharmaceuticals (TLX) Hit with Investor Lawsuit Alleging Misstatements on Prostate Cancer Drug Progress and Supply Chain Reliability-- Hagens Berman