Telix Pharmaceuticals Under Investigation for Securities Fraud and Misleading Disclosures

Pomerantz LLP is investigating claims on behalf of Telix Pharmaceuticals Limited investors regarding potential securities fraud or unlawful business practices. The investigation concerns disclosures regarding the company's prostate cancer therapeutic candidates. Telix's ADR price fell 10.44% after receiving a subpoena from the US Securities and Exchange Commission.

Telix Pharmaceuticals Limited (NASDAQ: TLX) has encountered a significant setback following a subpoena from the U.S. Securities and Exchange Commission (SEC) and a Complete Response Letter (CRL) from the FDA. The events have led to a substantial decline in the company's American Depositary Shares (ADS) price.

On August 28, 2025, Telix announced that the FDA had requested additional data on its drug to detect a form of kidney cancer, leading to a 16% drop in the price of its ADSs. This development comes after the company revealed on July 22, 2025, that it was the subject of an SEC investigation into its disclosures regarding the development of its prostate cancer therapeutic candidates. The SEC subpoena triggered a 10% fall in the ADS price the following day [1].

The FDA's CRL for Zircaix, intended for the diagnosis and characterization of renal masses as clear cell renal cell carcinoma, identified deficiencies in chemistry, manufacturing, and controls. The FDA also documented notices of deficiency issued to Telix's third-party manufacturing and supply chain partners that must be remediated. These events have contributed to the ongoing decline in Telix's stock price.

National shareholders rights firm Hagens Berman is investigating potential securities fraud or unlawful business practices by Telix. The investigation focuses on the company's statements concerning its prostate cancer therapeutic candidates and its drug for kidney cancer detection. Reed Kathrein, a partner at Hagens Berman leading the investigation, stated, "We’re investigating whether Telix may have misled investors about the development and commercial prospects of its candidates and whether other of the company’s therapies may be at issue" [1].

Investors who have suffered substantial losses due to these events are encouraged to submit their losses to Hagens Berman. Persons with knowledge that may assist the firm’s investigation are also urged to contact the firm. For more information, visit www.hbsslaw.com/investor-fraud/tlx or contact Reed Kathrein at 844-916-0895 or email TLX@hbsslaw.com [1].

References:
[1] https://www.globenewswire.com/news-release/2025/08/29/3141783/32716/en/Telix-Pharmaceuticals-Limited-TLX-Hits-Another-Roadblock-After-SEC-Subpoena-Shares-Fall-Again-Hagens-Berman.html