#None #Telix Pharmaceuticals #FDA CRL #SEC Subpoena

Urgent Alert for Telix Investors

In an important reminder for investors, the national shareholder rights law firm Hagens Berman has alerted stakeholders in Telix Pharmaceuticals Ltd. (NASDAQ: TLX) about a vital upcoming deadline. Investors have until January 9, 2026, to initiate action as the lead plaintiff in a class action lawsuit, which focuses on serious allegations stemming from recent regulatory issues affecting the company.

The concerns arose after a series of setbacks, including an SEC subpoena related to the company’s disclosures regarding its prostate cancer drug candidates TLX591 and TLX592, and a significant Complete Response Letter (CRL) from the FDA that has led to a dramatic plummet in stock prices. Following these developments, Telix's stock saw a steep decline of 21% after the final regulatory news, prompting concerns among investors about potential misleading statements made by the company.

Background of Regulatory Issues

The class action lawsuit alleges that Telix Pharmaceuticals and its executive team materially exaggerated the progress of their drug development and misled investors about the reliability of their third-party manufacturing partners. The SEC investigation is centered on the company’s alleged misleading disclosures regarding the advancement of their therapeutic candidates, which raises questions about the accuracy of the information provided to shareholders.

In addition to the SEC’s actions, the FDA's CRL poses significant concerns for investors. The CRL indicated that there were critical deficiencies in Chemistry, Manufacturing, and Controls (CMC) practices at third-party facilities, which were revealed through issued Form 483 notices. These difficulties have led to substantial regulatory hurdles, which the lawsuit claims were inadequately disclosed to the investors.

Impact on Investors

The immediate impact of these events has been substantial, as investors who purchased American Depository Shares (ADS) of Telix during the Class Period, between February 21, 2025, and August 28, 2025, may have suffered significant financial losses due to hidden flaws in supply chain and drug development disclosures. Legal experts state that these documented failures were not just minor oversights but were material misrepresentations that undermined investors’ trust and financial position.

Reed Kathrein, the leading partner at Hagens Berman overseeing this investigation, highlighted the dual failures regarding regulatory compliance concerning the SEC and the FDA, commenting on how these factors contributed to the stock's significant downturn. “The allegations suggest that revealed flaws in Telix Pharmaceuticals' business practices and their supply chain were concealed from investors, who were fed narratives of 'great progress' and 'global manufacturing capability' which turned out to be misleading,” said Kathrein.

What Investors Should Do

Hagens Berman is calling on Telix shareholders who have experienced significant losses to reach out and discuss their legal options. With the court's lead plaintiff deadline approaching rapidly, the firm encourages affected investors to act swiftly to protect their interests.

The lawsuit is part of Hagens Berman's broader commitment to holding companies accountable for practices that adversely affect shareholders. The firm has a strong track record of securing substantial recoveries for investors affected by corporate misrepresentation and negligence, emphasizing its role in advocating for investor rights.

For those interested in submitting their Telix investment losses or seeking further information regarding the case, Hagens Berman has provided a secure form for submissions, and encourages questions to be directed to their legal team. Furthermore, individuals with non-public information regarding Telix are invited to consider the SEC Whistleblower program, which offers rewards for critical information aiding legal investigations.

As January 9 draws near, the urgency for investors to respond is amplified. Staying informed and proactive is essential for stakeholders in Telix Pharmaceuticals as they navigate this uncertain regulatory landscape.

For updates and continuous information about this developing situation, investors should follow Hagens Berman on their official platforms.

Conclusion

In light of these substantial allegations against Telix Pharmaceuticals, investors are encouraged to evaluate their positions critically and consult with legal counsel to address any potential losses resulting from the alleged misstatements and regulatory pitfalls. Time is of the essence as the January 9 deadline approaches, marking a crucial opportunity for affected investors to seek redress and accountability.