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Telix (TLX) Facing Securities Class Action Lawsuit Over Alleged Dual Regulatory Failures: SEC Subpoena & FDA CRL on CMC/Supply Chain – Hagens Berman
Globenewswire· 2025-12-08 19:45
Core Viewpoint - The article discusses a securities class action lawsuit against Telix Pharmaceuticals Ltd. due to alleged misrepresentations regarding the development of its therapeutic candidates and supply chain issues, with a significant stock decline following regulatory setbacks [2][3]. Regulatory Failures - The lawsuit highlights two major regulatory events that allegedly corrected market perceptions of Telix's business: - On July 22, 2025, Telix disclosed an SEC subpoena related to its prostate cancer therapeutic candidates, which raised concerns about misleading disclosures on drug development progress [4]. - On August 28, 2025, the FDA rejected the Zircaix application, citing deficiencies in Chemistry, Manufacturing, and Controls (CMC) and documented Form 483 deficiencies at third-party manufacturers [4]. Stock Impact - Following these regulatory revelations, Telix's American Depositary Shares (ADSs) experienced a sharp decline, with a total stock drop of 21% after the final regulatory news [2][4]. Legal Issues - The complaint raises key legal issues, including whether Telix made misleading disclosures regarding drug development progress and whether the company concealed foundational weaknesses in its third-party supply chain and manufacturing processes [4]. Investor Actions - Hagens Berman, the law firm leading the litigation, is actively advising investors who purchased TLX ADSs during the class period and suffered losses due to undisclosed supply chain and therapeutic progress flaws [5]. Important Dates - The deadline for investors to move the court for appointment as lead plaintiff in the lawsuit is January 9, 2026 [1][6].
TLX Class Action Reminder: Telix Pharmaceuticals Ltd. Stockholders Should Contact Robbins LLP for Information About Leading the Class Action Against TLX
Globenewswire· 2025-12-04 19:46
Core Viewpoint - Telix Pharmaceuticals Ltd. is facing a class action lawsuit due to allegations of misleading investors regarding its prostate cancer therapeutic candidates and supply chain quality [1][2]. Group 1: Company Overview - Telix Pharmaceuticals Ltd. is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic radiopharmaceuticals [1]. Group 2: Class Action Details - The class period for the lawsuit is from February 21, 2025, to August 28, 2025 [1]. - The lawsuit was filed on behalf of investors who purchased or acquired Telix securities during the class period [1]. Group 3: Allegations - The complaint alleges that during the class period, defendants materially overstated the progress of Telix's prostate cancer therapeutic candidates, TLX591 and TLX592, as well as the quality of its supply chain and partners [2]. - Investors were reportedly surprised on July 22, 2025, when Telix disclosed an SEC investigation into its disclosures regarding the development of its prostate cancer therapeutic candidates [3]. - On August 28, 2025, Telix announced it received a Complete Response Letter (CRL) from the FDA, citing deficiencies in chemistry, manufacturing, and controls, and requested additional data for the drug product used in the phase 3 clinical trial [3]. Group 4: Impact on Stock - Following the announcement of the SEC investigation and the CRL from the FDA, the price of Telix's American Depositary Shares (ADSs) declined [3].
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
Prnewswire· 2025-12-03 22:39
Core Viewpoint - The article discusses a securities class action lawsuit against Telix Pharmaceuticals Ltd, alleging that the company and its executives misrepresented the progress of their prostate cancer drug candidates TLX591 and TLX592, as well as the reliability of their third-party manufacturing partners, leading to significant stock declines [1]. Regulatory Failures - On July 22, 2025, Telix disclosed an SEC subpoena related to the development of TLX591 and TLX592, raising questions about misleading disclosures regarding drug development progress [1]. - On August 28, 2025, the FDA issued a Complete Response Letter (CRL) rejecting the Zircaix (TLX250-CDx) application due to deficiencies in Chemistry, Manufacturing, and Controls (CMC), along with documented Form 483 deficiencies at third-party manufacturers [1]. Stock Impact - Following the regulatory revelations, Telix's American Depositary Shares (ADSs) experienced a sharp decline, including a 21% drop after the final regulatory news [1]. - The lawsuit claims that investors who purchased TLX ADSs during the class period (February 21, 2025 – August 28, 2025) may be entitled to damages due to the undisclosed issues [1]. Legal Proceedings - The deadline for investors to move the court for appointment as lead plaintiff in the class action lawsuit is January 9, 2026 [1]. - Hagens Berman, the law firm leading the litigation, is actively advising affected investors and has a history of securing substantial recoveries for investors [1].
Telix Pharmaceuticals (TLX) Sued After Alleged Misstatements on Prostate Cancer Drug Progress and Supply Chain Reliability – Hagens Berman
Globenewswire· 2025-12-02 22:17
Core Viewpoint - Telix Pharmaceuticals Ltd. is facing a securities class action lawsuit due to regulatory setbacks and significant stock declines, prompting an investigation into potential securities fraud [1][6]. Summary by Relevant Sections Class Action Details - The class action lawsuit, titled Thomas v. Telix Pharmaceuticals Ltd., aims to represent investors who purchased the company's securities between February 21, 2025, and August 28, 2025 [2]. - The lawsuit alleges that Telix and its executives made false and misleading statements about the company's business, inflating its valuation before the truth was revealed [2]. Core Allegations - The lawsuit claims Telix violated the Securities Exchange Act of 1934 by failing to disclose critical information regarding regulatory issues [3]. - Two major events led to a significant decline in Telix's American Depositary Shares (ADSs): 1. The FDA issued notices of deficiency to third-party manufacturing partners, contradicting earlier assurances about supply chain reliability [3]. 2. Following this news, Telix's ADSs dropped over 21% in value over two trading sessions [4]. Specific Misrepresentations - Management allegedly overstated the progress and commercial prospects of prostate cancer therapeutic candidates TLX591 and TLX592 [5]. - The company misrepresented the stability and regulatory compliance of its third-party supply chain, which was crucial for regulatory applications [5]. Regulatory Events Impacting Stock - The first significant stock drop occurred after Telix disclosed receiving a subpoena from the SEC on July 22, 2025, leading to a more than 13% decline in ADS price over two trading sessions [5]. - The second major blow came on August 28, 2025, when Telix received a Complete Response Letter from the FDA for TLX250-CDx, identifying deficiencies in the Chemistry, Manufacturing, and Controls package [5]. Investigation and Legal Proceedings - Hagens Berman is actively investigating the claims, focusing on discrepancies between the company's assurances and the regulatory revelations [7]. - The firm is looking into whether Telix knowingly misrepresented its drug development and manufacturing capabilities [7].
Telix Pharmaceuticals (TLX) Faces Securities Class Action After Alleged Misstatements on Prostate Cancer Drug Progress and Supply Chain Reliability-- Hagens Berman
Prnewswire· 2025-12-01 19:15
Core Viewpoint - Telix Pharmaceuticals Ltd. is facing a securities class action lawsuit due to regulatory setbacks and significant stock declines over the summer of 2025 [1] Summary by Sections Lawsuit Details - The lawsuit, titled Thomas v. Telix Pharmaceuticals Ltd., aims to represent investors who acquired the company's securities between February 21, 2025, and August 28, 2025 [3] - The complaint alleges that the company and its executives made false and misleading statements about the business, inflating the company's valuation before the truth was revealed [3] Core Allegations - The lawsuit claims that Telix violated the Securities Exchange Act of 1934 by failing to disclose: - Overstated therapeutic progress regarding prostate cancer therapeutic candidates TLX591 and TLX592 [4] - Misrepresentation of the stability, quality, and regulatory compliance of its third-party supply chain and manufacturing partners [5] Regulatory Events Impacting Stock - Two key events led to a significant decline in Telix's American Depositary Shares (ADSs): - **SEC Subpoena (July 22, 2025)**: The company disclosed receiving a subpoena from the SEC, leading to a stock price drop of over 13% in two trading sessions [6] - **FDA Rejection (August 28, 2025)**: Telix received a Complete Response Letter from the FDA for TLX250-CDx, resulting in a further decline of more than 21% in two trading sessions [7][8] Class Action and Investigation - The class action litigation is filed in the U.S. District Court for the Southern District of Indiana, seeking damages for investors who suffered losses due to the alleged securities fraud [10] - Hagens Berman is investigating the claims, focusing on discrepancies between the company's assurances and the regulatory revelations [11]
Telix Pharmaceuticals (TLX) Sued After Alleged Misstatements on Prostate Cancer Drug Progress and Supply Chain Reliability-- Hagens Berman
Prnewswire· 2025-11-28 22:25
Core Viewpoint - Telix Pharmaceuticals Ltd. is facing a securities class action lawsuit due to regulatory setbacks and significant stock declines, particularly following critical disclosures regarding its manufacturing and supply chain processes [1][4]. Allegations and Events - The lawsuit alleges that Telix and its executives made false and misleading statements about the company's business, inflating its valuation before the truth was revealed [2][3]. - Key allegations include overstated therapeutic progress for prostate cancer candidates TLX591 and TLX592, and misrepresentation of the stability and regulatory compliance of its third-party supply chain [5]. - The lawsuit identifies two major events that led to a sharp decline in Telix's stock price: 1. A subpoena from the SEC on July 22, 2025, which caused a more than 13% drop in stock price over two trading sessions [5]. 2. A Complete Response Letter from the FDA on August 28, 2025, rejecting the Biologics License Application for TLX250-CDx, leading to a further decline of over 21% in stock price [5][4]. Investigation - Hagens Berman is investigating the claims against Telix, focusing on discrepancies between the company's assurances and the regulatory revelations that followed [6].
Telix Pharmaceuticals Ltd. Shareholders with Large Losses Should Contact Robbins LLP for Information About the TLX Class Action
Prnewswire· 2025-11-28 15:00
Core Viewpoint - Telix Pharmaceuticals Ltd. is facing a class action lawsuit due to allegations of misleading investors regarding its prostate cancer therapeutic candidates, TLX591 and TLX592, during the class period from February 21, 2025, to August 28, 2025 [1][2]. Summary by Sections Company Overview - Telix Pharmaceuticals Ltd. is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic radiopharmaceuticals and associated medical technologies [1]. Class Action Details - A class action was filed on behalf of investors who purchased Telix securities during the specified class period, alleging that the company materially overstated the progress and quality of its prostate cancer therapeutic candidates and supply chain [1][2]. Allegations and Developments - The complaint states that on July 22, 2025, Telix disclosed an SEC investigation into its disclosures regarding the development of TLX591 and TLX592 [3]. - On August 28, 2025, Telix announced it received a Complete Response Letter (CRL) from the FDA, citing deficiencies in chemistry, manufacturing, and controls, and requested additional data for the drug product used in the phase 3 clinical trial [3]. - The CRL also indicated that notices of deficiency were issued to Telix's third-party manufacturing and supply chain partners, which must be addressed before resubmitting the Biologics License Application (BLA) [3]. Investor Actions - Shareholders interested in participating as lead plaintiffs in the class action must file their papers by January 9, 2026 [4]. - Investors can remain absent class members if they choose not to participate in the case [4]. Legal Representation - Robbins LLP is leading the class action, emphasizing that all representation is on a contingency fee basis, meaning shareholders incur no fees or expenses [5].
Telix Pharmaceuticals (TLX) Hit with Investor Lawsuit Alleging Misstatements on Prostate Cancer Drug Progress and Supply Chain Reliability-- Hagens Berman
Prnewswire· 2025-11-26 01:03
Core Viewpoint - Telix Pharmaceuticals Ltd. is facing a securities class action lawsuit due to regulatory setbacks and significant stock declines, with allegations of misleading statements regarding its business operations and therapeutic candidates [1][2][3]. Allegations - The lawsuit claims that Telix overstated the developmental progress and commercial prospects of its prostate cancer therapeutic candidates, specifically TLX591 and TLX592 [3]. - It is alleged that the company misrepresented the stability, quality, and regulatory compliance of its third-party supply chain and manufacturing partners, which were critical to its regulatory applications [4]. Regulatory Events Impacting Stock - The first significant stock decline occurred after Telix disclosed receiving a subpoena from the SEC on July 22, 2025, leading to a more than 13% drop in the price of Telix's American Depositary Shares (ADSs) over two trading sessions [5]. - A more severe decline followed the announcement of a Complete Response Letter (CRL) from the FDA on August 28, 2025, regarding TLX250-CDx (Zircaix), which identified deficiencies in the Chemistry, Manufacturing, and Controls (CMC) package, resulting in a further decline of over 21% in the stock price [6][7]. Investigation - Hagens Berman is actively investigating the claims against Telix, focusing on the discrepancies between the company's long-term assurances and the regulatory revelations that followed [8].
TLX Stockholder Alert: Shareholder Rights Law Firm Robbins LLP Reminds Investors of the Class Action Lawsuit Against Telix Pharmaceuticals Ltd.
Prnewswire· 2025-11-20 21:54
Core Viewpoint - A class action lawsuit has been filed against Telix Pharmaceuticals Ltd. for allegedly misleading investors regarding the progress and quality of its prostate cancer therapeutic candidates and supply chain [1][2]. Allegations - The lawsuit claims that Telix Pharmaceuticals materially overstated the progress of its prostate cancer therapeutic candidates, TLX591 and TLX592, as well as the quality of its supply chain and partners [2]. - Investors were reportedly caught off guard when Telix disclosed an SEC investigation into its disclosures related to the development of its prostate cancer therapeutic candidates on July 22, 2025 [3]. - On August 28, 2025, Telix announced it received a Complete Response Letter (CRL) from the FDA, citing deficiencies in chemistry, manufacturing, and controls, and requested additional data to establish comparability of the drug product used in the phase 3 clinical trial [3]. Impact on Stock - Following the announcement of the SEC investigation and the FDA's CRL, the price of Telix's American Depositary Shares (ADSs) declined significantly [3]. Class Action Participation - Shareholders interested in serving as lead plaintiffs in the class action must file their papers by January 9, 2026, but participation is not required to be eligible for recovery [4]. About Robbins LLP - Robbins LLP is a law firm specializing in shareholder rights litigation, dedicated to helping shareholders recover losses and improve corporate governance since 2002 [5].
Telix Pharmaceuticals Limited (TLX) Faces Securities Class Action Amid SEC Subpoena, Complete Response Letter – Hagens Berman
Globenewswire· 2025-11-14 18:55
Core Viewpoint - Telix Pharmaceuticals Limited is facing a securities class action lawsuit following significant stock declines due to a regulatory subpoena and an FDA rejection letter [1] Group 1: Legal Proceedings - The lawsuit, titled Thomas v. Telix Pharmaceuticals Ltd., seeks to represent investors who acquired Telix securities between February 21, 2025, and August 28, 2025 [3] - Hagens Berman, a national shareholders rights firm, is investigating the claims and encourages affected investors to report their losses [2][8] Group 2: Company Statements and Allegations - The litigation focuses on Telix's statements regarding its prostate cancer therapeutic candidates TLX591 and TLX592, as well as its kidney cancer detection candidate Zircaix [4] - During the class period, Telix claimed significant progress in its therapeutic pipeline and emphasized its global manufacturing capabilities as a competitive advantage [5] - The lawsuit alleges that Telix made false and misleading statements, overstating the progress of its prostate cancer candidates and the quality of its supply chain [5] Group 3: Regulatory Issues - On July 22, 2025, Telix disclosed an SEC investigation into its disclosures related to the development of its prostate cancer therapeutic candidates, which negatively impacted its stock price [6] - On August 28, 2025, Telix received a Complete Response Letter from the FDA for its Zircaix BLA, citing deficiencies in chemistry, manufacturing, and controls, which further affected its stock performance [7]