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INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Telix Pharmaceuticals Limited – TLX
GlobeNewswire News Room· 2025-07-28 15:30
Core Insights - Pomerantz LLP is investigating claims on behalf of investors of Telix Pharmaceuticals Limited regarding potential securities fraud or unlawful business practices [1][3] - On July 22, 2025, Telix received a subpoena from the U.S. Securities and Exchange Commission related to disclosures about its prostate cancer therapeutic candidates [3] - Following the news of the subpoena, Telix's American Depositary Receipt (ADR) price dropped by $1.70, or 10.44%, closing at $14.58 per ADR on July 23, 2025 [3] Company Overview - Telix Pharmaceuticals Limited is involved in the development of therapeutic candidates for prostate cancer [3] - The company is currently facing scrutiny from regulatory authorities, which may impact its operations and investor confidence [3] Legal Context - The Pomerantz Firm is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud and corporate misconduct [4] - The investigation by Pomerantz LLP indicates potential legal challenges ahead for Telix, which could lead to significant financial implications [1][4]
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Telix Pharmaceuticals Limited - TLX
Prnewswire· 2025-07-27 14:00
Core Viewpoint - Pomerantz LLP is investigating claims on behalf of investors of Telix Pharmaceuticals Limited regarding potential securities fraud or unlawful business practices by the company and its officers or directors [1]. Group 1: Company Developments - On July 22, 2025, Telix disclosed that it received a subpoena from the U.S. Securities and Exchange Commission, which is seeking various documents and information related to the company's disclosures about its prostate cancer therapeutic candidates [2]. - Following the news of the subpoena, Telix's American Depositary Receipt (ADR) price fell by $1.70, or 10.44%, closing at $14.58 per ADR on July 23, 2025 [2]. Group 2: Legal Context - Pomerantz LLP is recognized as a leading firm in corporate, securities, and antitrust class litigation, having a long history of fighting for the rights of victims of securities fraud and corporate misconduct [3].
INVESTOR ALERT: Investigation of Telix Pharmaceuticals Limited (TLX) Announced by Holzer & Holzer, LLC
GlobeNewswire News Room· 2025-07-23 21:02
Core Points - Holzer & Holzer, LLC is investigating whether Telix Pharmaceuticals Limited complied with federal securities laws following a subpoena from the U.S. Securities and Exchange Commission regarding the company's disclosures on prostate cancer therapeutic candidates [1] - The announcement of the subpoena led to a decline in Telix's stock price [1] Company Information - Telix Pharmaceuticals Limited is publicly traded on NASDAQ under the ticker TLX [1] - The company is involved in the development of therapeutic candidates for prostate cancer [1] Legal Context - Holzer & Holzer, LLC is a law firm specializing in securities litigation, representing shareholders and investors in various legal actions [3] - The firm has a history of recovering significant amounts for shareholders affected by corporate misconduct [3]
Telix Reports $204M Revenue, Up 63% YOY
Globenewswire· 2025-07-22 08:06
Core Insights - Telix Pharmaceuticals reported a significant increase in Q2 2025 revenue, reaching approximately $204 million, a 63% increase year-over-year, and reaffirmed its FY 2025 revenue guidance of $770 million to $800 million [3][6][22]. Financial Performance - Group revenue for Q2 2025 was $204 million, compared to $125 million in Q2 2024, marking a 63% increase. Revenue for Q1 2025 was $186 million, showing a 10% increase quarter-over-quarter [3][6]. - Global Illuccix® revenue was $154 million in Q2 2025, up 25% from $123 million in Q2 2024, and slightly increased by 2% from $151 million in Q1 2025 [3]. - RLS revenue reached $46 million in Q2 2025, with no revenue reported in Q2 2024, and a 39% increase from $33 million in Q1 2025 [3]. Business Highlights - Dose volumes for Illuccix rose 7% quarter-on-quarter in the U.S., indicating strong market demand despite competitive pricing pressures [4]. - The launch of Gozellix in the U.S. has commenced, with the product assigned a Level II HCPCS code, a key step towards reimbursement [6]. - The ProstACT Global Phase 3 trial achieved a milestone with all 30 patients consented for Part 1, and the trial is expanding into China, Japan, and Canada [7]. Therapeutics Development - TLX591 (Lu-rosopatamab tetraxetan) is progressing in its Phase 3 trial, with dosing completed for patients in two of the three arms [7]. - TLX592 (Ac-PSMA-RADmAb) has submitted an application for a Phase 1 study in Australia [7]. - TLX101 (I-iodofalan) received HREC approval in Australia for an international pivotal trial [7]. - TLX250 (¹⁷⁷Lu-DOTA-girentuximab) is enrolling patients in a Phase 1b/2 clinical trial for clear cell renal cell carcinoma [7]. Regulatory and Corporate Updates - Telix is cooperating with the U.S. SEC regarding a subpoena for documents related to its prostate cancer therapeutic candidates [11][12]. - The company has received country-level approvals for Illuccix in multiple European countries and is launching on a market-by-market basis [13]. - Telix has completed enrollment for the Illuccix China Phase 3 study, aiming for marketing authorization in Q4 2025 [13]. Manufacturing and R&D - Telix announced a GMP manufacturing facility in Yokohama, Japan, enhancing its global manufacturing strategy [14]. - The TMS facility in Brussels South, Belgium, has produced its first GMP commercial radiopharmaceutical doses [14]. - The company expects a 20% to 25% increase in R&D expenditure for FY 2025 compared to FY 2024 [22].
Gozellix Receives Permanent HCPCS Code
Globenewswire· 2025-07-09 22:45
Core Insights - Telix Pharmaceuticals has received a permanent HCPCS code for its next-generation PSMA PET imaging agent, Gozellix, which will enhance billing and reimbursement processes in the U.S. healthcare system [1][2][4] Group 1: Product Development and Approval - Gozellix is indicated for PET scanning of PSMA positive lesions in men with prostate cancer, particularly those with suspected metastasis or biochemical recurrence [3] - The product features an extended shelf-life and flexible production options, addressing logistical barriers to PSMA-PET imaging access [3][4] - Gozellix has been approved by the U.S. FDA, following the success of Telix's first-generation PSMA-PET imaging agent, Illuccix [5] Group 2: Market Impact and Future Prospects - The HCPCS code assignment is a significant milestone that supports clinical adoption and reimbursement for Gozellix, facilitating its commercial scale-up in the U.S. [2][4] - The CEO of Telix emphasized that this development is crucial for improving access to precision medicine imaging for prostate cancer patients across the U.S. [4] Group 3: Company Overview - Telix Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic radiopharmaceuticals [4] - The company operates internationally, with a presence in the U.S., Brazil, Canada, Europe, and Japan, aiming to address unmet medical needs in oncology and rare diseases [4]
Illuccix Approved in U.S. for Patient Selection for Pre-Taxane RLT
Globenewswire· 2025-06-23 11:15
Core Viewpoint - The U.S. FDA has approved a label expansion for Telix Pharmaceuticals' Illuccix® to include patient selection for radioligand therapy (RLT) in the pre-taxane setting, which is expected to significantly increase its clinical utilization [1][2]. Group 1: FDA Approval and Market Impact - The label expansion for Illuccix® is its third indication, allowing for the selection of patients indicated for PSMA-directed therapy [2]. - Following the FDA's approval of Pluvicto® for use in metastatic castration-resistant prostate cancer (mCRPC) patients, the clinical utilization of Illuccix® is projected to increase by at least 20,000 scans annually [2]. Group 2: Clinical Significance - The expansion of the indication allows clinicians to make more informed and personalized decisions earlier in the disease course, potentially providing access to life-prolonging targeted radionuclide therapy for more prostate cancer patients [3]. - PSMA-PET imaging has become a standard of care in the detection and management of prostate cancer, enhancing the diagnostic accuracy of Illuccix® [3]. Group 3: Product Information - Illuccix® is used for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer [4]. - The safety of gallium Ga 68 gozetotide was evaluated in 960 patients, with the most commonly reported adverse reactions being nausea, diarrhea, and dizziness, occurring at a rate of less than 1% [7][8].
Telix Precision Medicine Announces AlFluor Radiochemistry Platform
GlobeNewswire News Room· 2025-06-20 12:00
Core Insights - Telix Pharmaceuticals has launched a new PET radiochemistry solution called AlFluor™, based on 18F-aluminium fluoride, aimed at enhancing PSMA imaging capabilities [1][2]. Group 1: Product Development - The AlFluor™ platform allows flexible radiolabeling of PSMA with either AlF or gallium-68, and can also be used with ligands targeting neuroendocrine tumors and fibroblast activation protein [2]. - A strategic agreement has been signed with University Hospital Ghent and Ghent University for the development of a novel [18F]AlF-PSMA-11 targeting agent, which includes a comprehensive CMC package for a Drug Master File [3]. - The Phase 3 trial involving 96 prostate cancer patients showed that PSMA-11 labeled with 18F demonstrated diagnostic performance comparable to commercial 68Ga-labeled agents, achieving high specificity (~90%) for metastatic detection [4]. Group 2: Clinical and Regulatory Engagement - [18F]AlF-PSMA-11 has shown favorable biodistribution and high tumor-to-background ratios, with low off-target uptake in multiple studies, indicating its potential effectiveness [4]. - Telix is currently engaging with regulators to determine the approval pathway for [18F]AlF-PSMA-11, indicating progress towards commercialization [4]. Group 3: Company Strategy and Vision - The CEO of Telix emphasized the company's goal to expand PSMA-PET imaging through innovative and flexible product deployment, aligning with the evolving needs of physicians and patients [5]. - The introduction of AlFluor™ is part of Telix's strategy to offer a broad range of PSMA-PET imaging agents, enhancing service, flexibility, and reliability for customers [5]. Group 4: Company Overview - Telix Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic radiopharmaceuticals, with operations in multiple countries including the U.S., Brazil, Canada, Europe, and Japan [6]. - The company is listed on both the Australian Securities Exchange and the Nasdaq Global Select Market, indicating its international presence and investment appeal [6].
Telix Launches New Prostate Cancer Imaging Agent, Gozellix, in U.S.
Globenewswire· 2025-06-11 11:00
Core Viewpoint - Telix Pharmaceuticals has announced the commercial availability of its next-generation PSMA-PET imaging agent, Gozellix, for prostate cancer in the United States, enhancing diagnostic capabilities and patient access [1][4][7]. Company Overview - Telix Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic radiopharmaceuticals, headquartered in Melbourne, Australia, with operations in multiple countries including the U.S., Brazil, Canada, Europe, and Japan [8]. Product Details - Gozellix is indicated for PET scanning of PSMA positive lesions in men with prostate cancer, providing early and accurate detection of metastases with a specificity of 90% and capable of detecting micrometastases at PSA levels as low as 0.02 ng/mL [3][4]. - The product features an extended "hot" shelf-life of up to six hours, improving patient access and convenience by allowing greater transportation distances and clinical administration windows [5]. - Gozellix can be produced centrally or locally, offering flexibility in production and on-demand capacity, supported by the ARTMS QUANTM Irradiation System [6][10]. Market Context - PSMA-PET imaging has become the standard of care for staging and identifying biochemical recurrence of prostate cancer, yet only a small fraction of the 3.4 million men with prostate cancer in the U.S. have utilized this technology due to access challenges [4][5]. - Telix has applied for reimbursement for Gozellix for Medicare-eligible patients in the hospital outpatient setting, aiming to enhance accessibility [4][24].
Telix to Host Investor Day in New York City on June 11, 2025
Globenewswire· 2025-05-22 12:00
Company Overview - Telix Pharmaceuticals Limited is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic radiopharmaceuticals and associated medical technologies [5] - The company is headquartered in Melbourne, Australia, with international operations in the United States, Brazil, Canada, Europe (Belgium and Switzerland), and Japan [5] - Telix aims to address significant unmet medical needs in oncology and rare diseases through its portfolio of clinical and commercial stage products [5] Investor Day Announcement - Telix will host an Investor Day on June 11, 2025, in New York City, focusing on growth opportunities in its commercial and clinical portfolio [1][2] - The event will feature presentations from key members of the Telix leadership team, including the Managing Director and Group CEO, Dr. Christian Behrenbruch, and other executives [3] - Key Opinion Leaders will also share insights on the clinical utility and opportunities for Telix's theranostic candidates during the event [3] Attendance Information - Attendance at the Investor Day is by invitation only for qualified institutional investors and analysts, and advance registration is required [4][5]
Telix's Illuccix PSMA-PET Imaging Agent Approved in France
Globenewswire· 2025-04-28 22:30
Core Points - Telix Pharmaceuticals has received marketing authorization in France for its prostate cancer PET imaging agent, Illuccix®, which is used for detecting PSMA-positive lesions in adults with prostate cancer [1][2][3] Group 1: Product Approval and Clinical Impact - Illuccix® is indicated for use in various clinical settings, including primary staging of high-risk prostate cancer patients and suspected recurrent cases [2][8] - The approval is based on robust clinical data, including findings from the VISION trial, which is the largest Ga-68-based PSMA data set [3] - The product aims to improve the accuracy of prostate cancer management compared to conventional imaging methods, thus establishing a new standard of care [2][4] Group 2: Market Access and Collaboration - The approval allows hospitals and clinics in France to prepare PSMA-PET scans on-site, enhancing accessibility and reducing delays in diagnosis [3][4] - Telix will collaborate with IRE ELiT S.A. for the marketing and promotion of Illuccix® to healthcare professionals in France [6][7] - The partnership aims to ensure reliable access to PSMA-PET imaging technologies, addressing the growing demand across Europe [5][7] Group 3: Prostate Cancer Statistics in France - Prostate cancer is the most common cancer among men in France, with over 57,000 new cases diagnosed annually, significantly outpacing lung and bowel cancers [10] - The disease is also a leading cause of cancer-related deaths in men, with over 9,200 fatalities reported in 2022 [10]