Telix Pharmaceuticals Limited (NASDAQ: TLX)

This lawsuit is for anyone who acquired securities in Telix Pharmaceuticals Limited (NASDAQ: TLX) from February 21, 2025 through August 28, 2025.

The lawsuit alleges that the Company and certain of its executives violated federal law. Specifically, the lawsuit alleges that, throughout the time period mentioned above, the Company misled investors regarding its financial condition. More specifically, the lawsuit alleges that the Company misled investors by telling investors that the Company’s prospects for FDA approval of the Company’s prostate cancer therapeutic candidates were better than the Company knew the prospects to be.

On July 22, 2025, Telix disclosed that it had received a subpoena from the U.S. Securities and Exchange Commission (SEC) “seeking various documents and information primarily relating to the Company’s disclosures regarding the development of the Company’s prostate cancer therapeutic candidates.” On this news, the price of the Company’s stock dropped precipitously on unusually heavy trading volume. Then, on August 28, 2025, Telix announced that it has received a Complete Response Letter from the FDA for the Biologics License Application for TLX250- CDx (Zircaix®1 , 89Zr-DFO-girentuximab), identifying deficiencies relating to the Chemistry, Manufacturing, and Controls (CMC) package and requesting additional data to establish comparability between the drug product used in the ZIRCON Phase 3 clinical trial and the scaled-up manufacturing process intended for commercial use. Additionally, the FDA documented notices of deficiency issued to two third-party manufacturing and supply chain partners that will require remediation prior to resubmission. On this news, the price of the Company’s stock again dropped precipitously on unusually heavy trading volume.

The Law Offices of Howard G. Smith seeks to recover damages on behalf of class members. If you acquired securities in Telix Pharmaceuticals Limited (NASDAQ: TLX) Telix Pharmaceuticals Limited (NASDAQ: TLX) from February 21, 2025 through August 28, 2025 you may join the lawsuit by submitting your information online, or you may call the Law Offices of Howard G. Smith and speak to Mr. Smith directly to learn how he can protect your rights.