#USA #San Francisco #SEC Investigation #Telix Pharmaceuticals #TLX591

Hagens Berman Alerts Investors Regarding Telix Lawsuit

National shareholder rights law firm, Hagens Berman, has issued an important reminder for investors of Telix Pharmaceuticals Ltd. (NASDAQ: TLX) regarding the impending deadline of January 9, 2026, to apply for appointment as lead plaintiff in the ongoing securities class action lawsuit. This case stems from significant regulatory challenges faced by the company, which have had detrimental effects on its stock performance. Following the disclosure of an SEC subpoena and subsequent FDA Complete Response Letter on their prostate cancer drug candidates TLX591 and TLX592, the company's stock experienced a troubling decline of 21%.

Background of the Case

The lawsuit alleges that Telix and its executives significantly overstated the level of advancement in the development of their clinical candidates while misrepresenting the reliability of their third-party manufacturing and supply chain processes. Reed Kathrein, the partner leading this litigation, expressed concerns, noting that the claims made by management regarding 'substantial progress' and 'global manufacturing capabilities' stood in sharp contrast to the evident regulatory scrutiny they were facing.

Specifically, the complaint draws attention to documented deficiencies that were flagged under the FDA’s Form 483 issued to two of Telix's external partners. These issues were critical and allegedly hidden from investors, which fundamentally undermined trust in the company's operations. Investors who have incurred losses are being urged to address their rights and consider their participation in this class action.

Allegations and Regulatory Failures

The complaint highlights two pivotal regulatory failures that surfaced:

1. SEC Investigation: On July 22, 2025, Telix officially announced that it was under scrutiny by the SEC, which raised concerns over disclosures related to the progress of its prostate cancer therapies (TLX591 and TLX592).
- Key Issue: Whether Telix provided misleading information about the development progress of these drugs and potential impacts on investor decisions.

2. FDA Complete Response Letter (CRL): On August 28, 2025, the FDA rejected Telix's application for its product Zircaix (TLX250-CDx) due to deficiencies identified within Chemistry, Manufacturing, and Controls.
- Key Issue: Whether the company concealed substantial weaknesses in its third-party supply chain and manufacturing processes.

These failures led to a sharp decline in stock prices and raised critical questions about the transparency of the company’s disclosures to investors during the class period from February 21, 2025, to August 28, 2025. The significant drop in stock value reflects the market’s reaction to these revelations and emphasizes the need for accountability from corporate management.

Next Steps for Investors

Hagens Berman is a prominent law firm well-versed in litigation concerning investor rights. Investors who purchased Telix ADSs during the specified class period and suffered losses are encouraged to get in touch with the firm for a detailed discussion of their potential rights and options. The deadline for submitting lead plaintiff applications is fast approaching.

For further inquiries and to submit losses related to this case, interested parties can reach out directly to Reed Kathrein at 844-916-0895 or email: [email protected]. The firm advocates for the rights of investors and facilitates discussions around navigating these legal proceedings effectively.

Conclusion

Investors are reminded that failing to act within the outlined timeline could result in diminished chances of recovery for any losses suffered due to the alleged regulatory inadequacies faced by Telix. As the legal landscape unfolds, it remains pivotal for investors to stay informed and proactive in pursuing their rights under the law.