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Telix Pharmaceuticals Limited (TLX) Hits Another Roadblock After SEC Subpoena, Shares Fall Again -- Hagens Berman

1. TLX shares fell 16% after FDA requested more data on a drug. 2. The SEC is investigating potential misinformation from Telix about drug candidates. 3. Telix received a Complete Response Letter from the FDA on its renal cancer drug. 4. FDA identified deficiencies requiring additional data from Telix's manufacturing process. 5. Legal investigations could impact investor confidence in Telix's future prospects.

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FAQ

Why Very Bearish?

The significant drop in stock price reflects investor concern over regulatory scrutiny and product viability, which historically leads to prolonged downturns for similar biotech firms facing FDA challenges and potential legal issues.

How important is it?

The article highlights critical FDA interactions and legal investigations, both of which could severely impact TLX's market perception and future business prospects.

Why Short Term?

The current issues with the FDA and SEC investigations are likely to affect TLX's stock performance in the immediate future, similar to past cases where FDA delays resulted in sustained negative stock sentiment.

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VRTXEXASPFE
SAN FRANCISCO, Aug. 29, 2025 (GLOBE NEWSWIRE) -- On August 28, 2025, investors in Telix Pharmaceuticals Limited (NASDAQ: TLX) saw the price of their American Depositary Shares fall about 16% after the company said the FDA sought more data on its drug to detect a form of kidney cancer. The development comes after Telix revealed, on July 22, 2025, that it received a subpoena from the SEC, driving the price of ADSs down 10% the next day. National shareholders rights firm Hagens Berman continues to investigate whether Telix may have misled investors about certain of its drug candidates and urges Telix investors who suffered substantial losses to submit your losses now. The firm also encourages persons with knowledge who may be able to assist in the investigation to contact its attorneys. Visit: www.hbsslaw.com/investor-fraud/tlx Contact the Firm Now: TLX@hbsslaw.com                                      844-916-0895 Telix Pharmaceuticals Limited (TLX) Investigation: The investigation is focused on the propriety of Telix’s statements concerning certain of its prostate cancer therapeutic candidates and also statements concerning its drug which would be used to help detect a specific type of kidney cancer. While specific details of the firm’s investigation are evolving, the triggering event surfaced after hours 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.” Most recently, on August 28, 2025, Telix said it received a Complete Response Letter (“CRL”) from the FDA for the company’s Biologics License Application for Zircaix, which is intended for the diagnosis and characterization of renal masses as clear cell renal cell carcinoma. 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. Each of these events drove the price of Telix ADSs sharply lower. “We’re investigating whether Telix may have misled investors about the development and commercial prospects of its candidates and whether other of the company’s therapies may be at issue,” said Reed Kathrein, the Hagens Berman partner leading the investigation. If you invested in Telix and have substantial losses, or have knowledge that may assist the firm’s investigation, submit your losses now » If you’d like more information and answers to frequently asked questions about the Telix 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 BermanHagens 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. Contact: Reed Kathrein, 844-916-0895

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