Telix Pharmaceuticals (TLX) Hit with Investor Lawsuit Alleging Misstatements on Prostate Cancer Drug Progress and Supply Chain Reliability-- Hagens Berman

SAN FRANCISCO, Nov. 25, 2025 /PRNewswire/ --Telix Pharmaceuticals Ltd. (NASDAQ: TLX), a commercial-stage biopharmaceutical company specializing in diagnostic and therapeutic radiopharmaceuticals, is now the target of a securities class action lawsuit following a series of regulatory setbacks and steep stock declines over the summer.

Hagens Berman is actively investigating the allegations and urges Telix investors who suffered substantial losses to submit your losses now.

Class Period: Feb. 21, 2025 – Aug. 28, 2025
Lead Plaintiff Deadline: Jan. 9, 2026
Visit: www.hbsslaw.com/investor-fraud/tlx
Contact the Firm Now: [email protected]
                                       844-916-0895

Telix Pharmaceuticals Limited (TLX) Securities Class Action

The complaint, captioned Thomas v. Telix Pharmaceuticals Ltd., seeks to represent investors who acquired the company's securities between February 21, 2025, and August 28, 2025 (the "Class Period"). The lawsuit alleges that the company and certain top executives made false and misleading statements about critical aspects of its business, inflating the company's valuation before the truth emerged.

The Core Allegations

The class action charges Telix with violating the Securities Exchange Act of 1934 by allegedly failing to disclose that:

1. Overstated Therapeutic Progress: Management materially overstated the developmental progress and commercial prospects of its prostate cancer therapeutic candidates, specifically TLX591 and TLX592.

2. Supply Chain Misrepresented: The company materially overstated the stability, quality, and regulatory compliance of its third-party supply chain and manufacturing partners, which proved crucial to its regulatory applications.

Regulatory Revelations Trigger Stock Collapse

The lawsuit points to two distinct events that corrected the market's perception and caused Telix's American Depositary Shares (ADSs) to crater:

1. SEC Subpoena (July 22, 2025): The first drop occurred when Telix disclosed it had received a subpoena from the U.S. Securities and Exchange Commission (SEC). The subpoena requested various documents and information relating primarily to the company's public disclosures regarding the development of its prostate cancer therapeutics candidates. Following this news, the price of Telix ADSs fell by more than 13% over two trading sessions.

2. FDA Rejection on Manufacturing (August 28, 2025): The second, more severe blow came when Telix announced it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Biologics License Application (BLA) of TLX250-CDx (Zircaix), an investigational PET imaging agent. The CRL, a formal rejection of the application, identified "deficiencies relating to the Chemistry, Manufacturing, and Controls (CMC) package."

Crucially, the FDA additionally "documented notices of deficiency (Form 483) issued to two third-party manufacturing and supply chain partners that will require remediation prior to resubmission." These deficiencies, related to the quality and control processes at manufacturing facilities, directly contradicted the company's earlier assurances regarding its supply chain reliability.

On this news, Telix's ADSs experienced a significant further decline of more than 21% over two trading sessions, according to the complaint.

The class action litigation, filed in the U.S. District Court for the Southern District of Indiana, seeks to recover damages for investors who suffered substantial losses as a result of the alleged securities fraud.

Hagens Berman's Investigation

The alleged claims are being actively investigated by national investor rights firm Hagens Berman. The firm is focused on the alleged discrepancies between the company's long-term assurances and the swift, devastating regulatory revelations.

"We're looking into whether the Company knowingly misrepresented the foundational integrity of its drug development and manufacturing capabilities," said Reed Kathrein, the Hagens Berman partner leading the investigation.

If you invested in Telix and have substantial losses, or have knowledge that may assist the firm's investigation, submit your losses now »

If you'd like more information and answers to frequently asked questions about the Telix case and our investigation, read more »

Whistleblowers: Persons with non-public information regarding Telix should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email [email protected].

About Hagens Berman
Hagens Berman is a global plaintiffs' rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman's team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw. 

SOURCE Hagens Berman Sobol Shapiro LLP