Telix Pharmaceuticals Limited (TLX) Faces Securities Class Action Amid SEC Subpoena, Complete Response Letter -- Hagens Berman

SAN FRANCISCO, Nov. 12, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (NASDAQ: TLX), a commercial-stage biopharmaceutical company focused on medical imaging and therapeutic radiopharmaceuticals, is now the target of a securities class action lawsuit, capping a tumultuous several months that saw the company's stock crater following revelations of a regulatory subpoena and an FDA rejection letter.

National shareholders rights firm Hagens Berman is actively investigating the alleged legal claims and urges Telix investors who suffered substantial losses to submit your losses now. The firm also encourages persons with knowledge who may be able to assist in the investigation to contact its attorneys.

Class Period: Feb. 21, 2025 – Aug. 28, 2025
Lead Plaintiff Deadline: Jan. 9, 2026
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Telix Pharmaceuticals Limited (TLX) Securities Class Action:

The case, styled Thomas v. Telix Pharmaceuticals Ltd., et al., No. 1:25-cv-02299 (D. Ind.), seeks to represent investors in Telix Pharmaceuticals Ltd. (NASDAQ: TLX) who purchased or otherwise acquired Telix securities between February 21, 2025 and August 28, 2025.

The litigation is focused on the propriety of Telix’s statements concerning certain of its prostate cancer therapeutic candidates (TLX591 and TLX592) and also on company statements concerning Zircaix, its candidate which would be used to help detect a specific type of kidney cancer.

During the Class Period, Telix assured investors that “[w]e’re making great progress across our therapeutic pipeline, notably in the late-stage assets being brain, kidney and, of course our prostate cancer program which is now in Phase 3.” The company has also touted its “truly global manufacturing capability” as a “very important source of our competitive advantage[.]”

The lawsuit alleges that Telix made false and misleading statements while failing to disclose crucial information to investors. The complaint alleges that Telix materially overstated the progress being made with regard to its prostate cancer therapeutic candidates and materially overstated the quality of its supply chain and manufacturing partners.

According to the complaint’s allegations, investors were surprised on July 22, 2025, when Telix revealed that it is the subject of an SEC investigation into the company’s disclosures “regarding the development of the Company’s prostate cancer therapeutic candidates” -- TLX591 and TLX592. The specific details of the investigation are evolving, but the news was serious enough to drive the price of Telix’s ADSs sharply lower.

Then, another concerning development occurred on August 28, 2025. That day, Telix said it received a Complete Response Letter (“CRL”) from the FDA for the company’s Zircaix BLA. The company said the CRL identified deficiencies in chemistry, manufacturing, and controls and requested additional data to establish comparability of the drug product used in the phase 3 clinical trial and the manufacturing process intended for commercial use. Telix also revealed that the FDA documented notices of deficiency issued to its third-party manufacturing and supply chain partners that must be remediated prior to resubmitting the BLA. Telix’s ADSs traded sharply lower again on this news.

“We’re investigating claims that Telix may have misled investors about the development and commercial prospects of TLX591, TLX591 and Zircaix, and whether other of the company’s therapies may be at issue,” 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.

Contact:
Reed Kathrein, 844-916-0895