TLX LAWSUIT DEADLINE: Hagens Berman Urges Telix Investors to Act by Jan. 9 Over Alleged Dual Regulatory Failures: SEC Subpoena & FDA CRL on CMC/Supply Chain
PR Newswire
SAN FRANCISCO, Dec. 3, 2025
Partner Reed Kathrein Scrutinizes Alleged Misstatements on Prostate Cancer Drug TLX591 Progress and Third-Party Manufacturing Deficiencies (Form 483)
SAN FRANCISCO, Dec. 3, 2025 /PRNewswire/ -- National shareholder rights law firm Hagens Berman reminds investors that the deadline to move the Court for appointment as lead plaintiff in the securities class action lawsuit against Telix Pharmaceuticals Ltd. (NASDAQ: TLX) is January 9, 2026.
The lawsuit follows a series of regulatory setbacks and steep stock declines, including a 21% drop after the final regulatory news. The complaint alleges that Telix and its executives materially overstated the developmental progress of its therapeutic candidates (specifically TLX591 and TLX592) and misrepresented the reliability and regulatory compliance of its third-party supply chain and manufacturing partners.
"The complaint alleges that management's claims of 'great progress' and 'truly global manufacturing capability' were directly at odds with the reality of regulatory scrutiny," said Reed Kathrein, the Hagens Berman partner leading the litigation. "We are specifically investigating the documented notices of deficiency (Form 483) issued to two third-party partners which led to the FDA's Complete Response Letter (CRL). These failures were material and allegedly concealed from investors. The firm urges Telix investors who suffered substantial losses to contact the firm now to discuss their rights."
Legal Analysis: Dual Regulatory Failures & Supply Chain Deception
The complaint highlights two distinct regulatory events that allegedly corrected the market's misperception of Telix's business, operation and prospects:
Alleged Regulatory Failure | Alleged Disclosure Event & Stock Impact | Key Legal Issues |
SEC Investigation | On July 22, 2025, Telix revealed an SEC Subpoena relating to disclosures on the development of its prostate cancer therapeutic candidates (TLX591/TLX592). | Whether TLX made misleading disclosures on drug development progress. |
FDA Complete Response Letter (CRL) | On August 28, 2025, the FDA rejected the Zircaix (TLX250-CDx) application, citing deficiencies in Chemistry, Manufacturing, and Controls (CMC) and documented Form 483 deficiencies at third-party manufacturers. | Whether the company concealed foundational weaknesses in the third-party supply chain and manufacturing processes. |
Total Stock Drop | Telix ADSs fell sharply following these regulatory revelations. | Whether investors who purchased TLX ADSs during the Class Period (Feb. 21, 2025 – Aug. 28, 2025) are entitled to damages. |
Next Steps: Contact Partner Reed Kathrein Today
Hagens Berman is one of the nation's top plaintiff litigation firms, securing substantial recoveries for investors.
Mr. Kathrein and the firm's investor fraud attorneys are actively advising investors who purchased TLX ADSs during the Class Period and suffered substantial losses due to the undisclosed supply chain and therapeutic progress flaws.
The Lead Plaintiff Deadline is January 9, 2026.
TO SUBMIT YOUR TELIX (TLX) LOSSES NOW, PLEASE USE THE SECURE FORM BELOW:
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 TLX@hbsslaw.com.
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.
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SOURCE Hagens Berman Sobol Shapiro LLP
