Telix Pharmaceuticals Limited

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, Telix’s stock price fell $1.70, or 10.4%, to close at $14.58 per share on July 23, 2025, thereby injuring investors.

Then, on August 28, 2025, Telix announced that it had received a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application (BLA) for TLX250-CDx (Zircaix®1, 89Zr-DFO-girentuximab), stating that the CRL “identifies deficiencies relating to the Chemistry, Manufacturing, and Controls (CMC) package” and that the FDA has “requested 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.”

On this news, Telix’s stock price fell $1.95, or 16.1%, to close at $10.15 per share on August 28, 2025, thereby injuring investors further.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) Defendants materially overstated the progress Telix had made with regard to prostate cancer therapeutic candidates; (2) Defendants materially overstated the quality of Telix’s supply chain and partners; and (3) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.