21% TLX PLUNGE: Hagens Berman Urges Telix Investors to Act by Jan. 9 in Class Action Suit Over SEC Subpoena & FDA CRL on Manufacturing Failures

Partner Reed Kathrein Scrutinizing Alleged Misstatements on Prostate Cancer
Drug TLX591 Progress and Third-Party Manufacturing Deficiencies (Form 483)

SAN FRANCISCO, Dec. 11, 2025 /PRNewswire/ -- National shareholder rights law firm Hagens Berman is issuing a reminder to investors in Telix Pharmaceuticals Ltd. (NASDAQ: TLX) that the deadline to move the Court for appointment as lead plaintiff in the pending securities class action lawsuit is January 9, 2026.

The lawsuit follows a series of regulatory setbacks—including an SEC subpoena and a devastating Complete Response Letter (CRL) from the FDA—that led to a sharp stock decline, with the final news triggering a 21% drop.

The complaint alleges that Telix and its executives materially overstated the developmental progress of its therapeutic candidates and misrepresented the reliability and regulatory compliance of its third-party supply chain and manufacturing partners.

"The Telix complaint alleges a dual regulatory failure: first the SEC apparently questioning the development disclosures, and then the FDA alleged to have rejected a BLA based on fundamental CMC (Chemistry, Manufacturing, and Controls) and Form 483 deficiencies at the third-party manufacturers," said Reed Kathrein, the Hagens Berman partner leading the litigation. "The complaint alleges these documented failures were material and allegedly concealed, making the company's claims of 'great progress' and 'truly global manufacturing capability' materially false."

The firm urges Telix investors who suffered substantial losses to contact the firm now to discuss their rights."

Alleged Misstatements, Concealment of CMC Deficiencies, and Investor Losses

The complaint alleges two distinct regulatory events that purportedly corrected the market's misperception of Telix's business and prospects:

• SEC Investigation into Drug Progress: Telix received an SEC Subpoena related to its disclosures on the development of its prostate cancer therapeutic candidates (TLX591/TLX592), suggesting misleading statements about the drugs' advancement.
  
  
• FDA Complete Response Letter (CRL): The FDA rejected the Zircaix application, citing severe deficiencies in Chemistry, Manufacturing, and Controls (CMC) and issuing Form 483 notices to two third-party supply chain partners. This allegedly revealed foundational weaknesses the company the complaint claims were concealed.
  
  
• Investor Damages: The cumulative effect of these disclosures allegedly caused Telix ADSs to fall sharply, including a 21% drop following the final regulatory news, leading to damages for investors who purchased TLX ADSs during the Class Period (Feb. 21, 2025 – Aug. 28, 2025)

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:

• Submit Your Telix (TLX) Class Period Investment Losses Now
• Contact: Reed Kathrein at 844-916-0895 or email [email protected]

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. 

SOURCE Hagens Berman Sobol Shapiro LLP