#United States #San Francisco #Telix Pharmaceuticals #FDA CRL #SEC Subpoena

TLX Lawsuit Update: Urgent Action Required for Investors

Hagens Berman, a leading national shareholder rights law firm, has raised an alarm for investors of Telix Pharmaceuticals Ltd. (NASDAQ: TLX) regarding a pressing deadline. Investors need to act by January 9, 2026, to be considered for lead plaintiff status in an ongoing class-action lawsuit connected to serious regulatory failures impacting the company's stock performance.

Recent Regulatory Challenges

The past few months have seen Telix navigating a tumultuous landscape due to a series of substantial regulatory hurdles. The company suffered a significant decline in its stock value—specifically a staggering 21% drop—triggered by a combination of news concerning an SEC subpoena that scrutinized Telix's disclosures about its prostate cancer drug candidates and a Complete Response Letter (CRL) from the FDA. The CRL referenced fundamental deficiencies related to Chemistry, Manufacturing, and Controls (CMC), raising serious questions regarding the integrity of Telix's third-party supply chain arrangements.

Allegations of Misrepresentation

The core of the complaint indicates that executives at Telix allegedly overstated the development progress of its therapeutic candidates, misleading investors about the reliability and efficacy of its manufacturing partners. According to Reed Kathrein, the lead partner overseeing this investigation, the complaint highlights severe failures in Telix’s regulatory compliance. These allegations paint a picture of a company that misrepresented its claims of progress and global manufacturing capability to its investors.

Distinct Incidents Affecting Stock Prices

Two major incidents underscored in the complaint contributed to the backlash against Telix:

• - SEC Subpoena: This inquiry relates to the company’s statements about the regulatory advancement of their prostate cancer therapies TLX591 and TLX592. The SEC has questioned Telix's disclosures regarding the therapeutic candidates, suggesting they may have been misleading.
• - FDA's Complete Response Letter: The FDA's rejection of the company's Zircaix application highlighted key deficiencies, including concerns regarding CMC standards. Furthermore, two of Telix's third-party manufacturers received Form 483 notices, indicating significant compliance issues that were allegedly concealed from investors.

Implications for Investors

These revelations have undeniably impacted investor confidence and consequently, the price of Telix's Ads. The cumulative fallout from both incidents is said to have inflicted significant financial losses on investors, particularly those who acquired shares during the specified class period (February 21, 2025 to August 28, 2025). Those impacted may be entitled to recover losses through this ongoing lawsuit.

Call to Action

Hagens Berman is urging any Telix investors who experienced losses to reach out for legal advice promptly. Investors can consult with the firm’s attorneys who specialize in securities fraud. The deadline for submitting claims is looming, making it crucial for interested parties to take action before January 9, 2026. The firm emphasizes its commitment to fight for corporate accountability, and has a proven track record of securing recoveries for investors affected by corporate misconduct.

For more information or to submit losses relating to the Telix class action, investors can directly contact partner Reed Kathrein at 844-916-0895 or via email at the contact provided on the firm’s website.

Stay updated with developments by following Hagens Berman on their official channels. This is your chance to stand against corporate negligence.