Telix Pharmaceuticals Limited (TLX) Securities Class Action

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^Ò, 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^Ò 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.

FREQUENTLY ASKED QUESTIONS ABOUT THE CASE

What is the TLX investigation about?

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

WHAT SHOULD I DO?

I worked at TLX. What should I do?

If you were an employee of TLX, you may have valuable information that could be relevant to the investigation. Hagens Berman is one of the nation’s top whistleblower law firms, and has successfully represented many individuals who come forward with information regarding corporate malfeasance. Under the new SEC Whistleblower 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, contact Reed Kathrein at 844-916-0895 or TLX@hbsslaw.com.

There are multiple law firms participating, do I need to contact all of them?

No, you do not need to contact all participating law firms. Generally, class-action investigations and lawsuits are consolidated into a single case to streamline the legal process, and attorneys from only a few law firms are selected to serve in a leadership role on the consolidated case. Hagens Berman has a proven track record of being appointed to leadership roles in complex, multidistrict litigation regarding investor fraud and other consumer rights issues, and your claim will be handled by attorneys who have helped secure approximately $325 billion in class-action settlements on behalf of individuals who have suffered due to corporate malfeasance and the wrongdoing of other powerful institutions.

AM I ELIGIBLE?

What is the threshold amount to be eligible? What are “substantial” losses?

The threshold amount and the definition of "substantial" losses may vary depending on a number of factors specific to the case, including the size of the company, market cap, shares outstanding and who holds them and the damages alleged by the fraud. In general, to be eligible to participate in a class-action lawsuit, you must be able to demonstrate that you suffered financial losses as a result of the alleged wrongdoing and that your losses meet the criteria set by the court or law firm. Fill out the form and submit your losses.

CAN I PARTICIPATE?

Am I affected? What do I need to do to participate?

If you were an investor in TLX, you may be affected and eligible to participate in the case. To determine your eligibility and potential involvement, fill out the form and submit your losses.

Can any TLX investor participate?

In most class-action investigations and cases, any investor who meets the eligibility criteria, including purchasing the shares during the relevant period, can participate, regardless of the size of their investment. Fill out the form to find out your rights.

I bought on a non-U.S. Exchange. Can I participate?

No. This investigation only covers shares bought on a U.S. exchange, i.e. NASDAQ or NYSE. Fill out the form to find out your rights.

Am I included if I still hold my shares, or do I need to sell to participate?

Participation is based on purchasing shares during the relevant period, rather than your current holdings. Accordingly, you do not need to sell to participate. Fill out the form to find out your rights.