MELBOURNE, Australia and INDIANAPOLIS, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) will participate in the upcoming UBS Global Healthcare Conference in Palm Beach, FL (U.S.) and in the Jefferies Global Healthcare Conference in London (UK). Kevin Richardson, Chief Executive Officer, Precision Medicine will take part in a fireside chat with UBS on Monday, November 10, 2025 at 12.30pm EST (Tuesday, Nov 11 at 4:30am AEDT). Richard Valeix, Chief Executive Offi ...

Core Points - Bragar Eagel & Squire, P.C. is investigating potential claims against Telix Pharmaceuticals Limited regarding possible violations of federal securities laws and unlawful business practices [1][2] - The investigation is aimed at stockholders who have suffered losses from their investments in Telix [1][2] - Telix's stock price experienced a significant decline following the announcement of a subpoena from the U.S. Securities and Exchange Commission, which sought documents related to the company's prostate cancer therapeutic candidates [5] Investigation Details - Investors who purchased Telix shares and incurred losses are encouraged to contact Bragar Eagel & Squire for more information about their legal rights and potential claims [2] - The law firm emphasizes that there is no cost or obligation for investors to inquire about their rights [2] About the Law Firm - Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, South Carolina, and California, specializing in representing individual and institutional investors in complex litigation [3] - The firm handles cases in both state and federal courts across the country [3]

Core Viewpoint - The Portnoy Law Firm has initiated an investigation into Telix Pharmaceuticals Limited for possible securities fraud, potentially leading to a class action lawsuit on behalf of investors [1]. Group 1: Legal Actions and Investigations - The Portnoy Law Firm is encouraging investors to contact them to discuss their legal rights and options for pursuing claims to recover losses [2]. - On July 22, 2025, Telix received a subpoena from the U.S. Securities and Exchange Commission regarding disclosures related to the development of its prostate cancer therapeutic candidates [3]. - Following the SEC subpoena news, 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]. Group 2: Firm Background - The Portnoy Law Firm has a history of representing investors in claims related to corporate wrongdoing, with the founding partner having recovered over $5.5 billion for aggrieved investors [4].

Core Insights - Telix Pharmaceuticals has received recognition for its investigational PET agent TLX250-CDx in updated clinical guidelines for molecular imaging of renal masses, marking a significant advancement in precision medicine for renal cancer [1][5][6] Group 1: Clinical Guidelines and Implications - The updated guidelines from SNMMI, EANM, and ACNM highlight the potential of molecular imaging for risk stratification of indeterminate renal masses, which can enhance patient management decisions [2] - The guidelines endorse TLX250-CDx PET as a well-tolerated and accurate method for non-invasive identification of clear cell renal cell carcinoma (ccRCC), contrasting with traditional F-FDG PET methods that have high renal excretion rates [3][4] Group 2: Clinical Trial Data - Data from Telix's pivotal Phase 3 ZIRCON trial demonstrated that TLX250-CDx met all primary and secondary endpoints, achieving a sensitivity of 86%, specificity of 87%, and a positive predictive value (PPV) of 93% for ccRCC, including small lesions [4][6] - TLX250-CDx specifically binds to carbonic anhydrase IX (CAIX), a target protein present in over 95% of ccRCC cells, resulting in high tumor-to-background ratios and consistent imaging results [4][6] Group 3: Company Statements and Future Outlook - Experts, including Professor Brian Shuch, emphasize that the inclusion of TLX250-CDx PET in clinical guidelines represents a shift towards precision medicine, providing clinicians with improved diagnostic tools for individualized treatment planning [5] - Telix's CEO, Kevin Richardson, noted that this endorsement by a global expert panel is expected to drive adoption and implementation of TLX250-CDx in clinical workflows, ultimately enhancing patient outcomes [5]

Core Insights - Telix Pharmaceuticals has initiated a Phase 1 clinical trial for TLX090, a therapeutic radiopharmaceutical aimed at treating pain from bone metastasis in cancer patients [1][2]. Company Overview - Telix Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic radiopharmaceuticals [7][8]. - The company is headquartered in Melbourne, Australia, with operations in multiple countries including the United States, United Kingdom, and Japan [7]. Clinical Trial Details - The SOLACE trial will enroll up to 33 patients with advanced cancer that has metastasized to the bony skeleton, evaluating pharmacokinetics, dosimetry, safety, and pain relief [2][3]. - TLX090 aims to provide a non-opioid solution for patients suffering from bone pain, addressing a significant unmet medical need [2][4]. Market Need and Treatment Comparison - Pain from osteoblastic bone metastases affects approximately 400,000 new cases annually, with up to 90% of metastatic prostate cancer patients experiencing this pain [3][4]. - Current treatments, including opioids and external beam radiation therapy, often provide only partial relief and come with significant drawbacks [4][5]. - TLX090 is positioned as a cost-effective, systemic, and targeted alternative that may offer up to 3-4 months of pain relief with the potential for repeat doses [5][6]. Expert Commentary - Medical professionals involved in the SOLACE trial express optimism about TLX090's potential to improve pain management and quality of life for patients with metastatic bone pain [6].

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Telix Pharmaceuticals Limited for possible violations of federal securities laws and unlawful business practices affecting stockholders [1][2]. Investigation Details - The law firm is reaching out to investors who purchased or acquired Telix shares and suffered losses, encouraging them to discuss their legal rights and options [1][2]. - There is no cost or obligation for investors to contact the firm regarding these claims [2]. Company Background - Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York, South Carolina, and California, representing individual and institutional investors in various complex litigations [3]. - The firm specializes in commercial, securities, and derivative litigation in state and federal courts across the United States [3]. Recent Developments - On July 22, 2025, Telix received a subpoena from the U.S. Securities and Exchange Commission, seeking documents related to the company's disclosures about its prostate cancer therapeutic candidates [5]. - Following this news, Telix's American Depositary Receipt (ADR) price dropped by $1.70, or 10.44%, closing at $14.58 per ADR on July 23, 2025 [5].

Core Insights - Telix Pharmaceuticals reported a strong third-quarter performance for fiscal 2025, with revenues of $206 million, reflecting a 53% year-over-year increase and a 1% sequential increase [1] - The company has raised its fiscal year 2025 sales guidance from a range of $770 million-$800 million to $800 million-$820 million [6] Revenue Breakdown - PSMA imaging revenue increased by 17% to $155 million, while RLS third-party revenue reached $47 million [1] - The increase in dose volumes by 3% indicates that competitive pricing pressures are stabilizing [5] Product Developments - Gozellix, a radioactive diagnostic agent for prostate cancer, is now fully reimbursed by CMS, effective October 1 [2] - Illuccix has been approved in 19 European markets and the U.K., with commercial launches already initiated in several countries including the U.K., Germany, and France [3] Clinical Trials - The BiPASS trial for MRI + PSMA-PET for prostate cancer diagnosis has begun dosing its first patients [4] - The ProstACT Global Phase 3 trial–Part 2 is now open for enrollment, with preliminary safety profile and dosimetry results expected after patient monitoring [4] Market Performance - Telix Pharmaceuticals' stock increased by 3.60%, reaching $9.88 at the time of publication [6]

Core Insights - Telix Pharmaceuticals reported a significant increase in Q3 2025 revenue, reaching approximately $206 million, which is a 53% increase year-over-year [3][6] - The company has raised its full-year 2025 revenue guidance to between $800 million and $820 million, reflecting strong performance in its PSMA imaging products [6][16] - Gozellix has received full reimbursement from the Centers for Medicare and Medicaid Services (CMS) in the U.S., effective October 1, 2025, enhancing its market position [6][15] Financial Performance - Q3 2025 group revenue was $206 million, compared to $135 million in Q3 2024, marking a 53% increase [3] - PSMA imaging revenue for Q3 2025 was $155 million, up 17% from $132 million in Q3 2024 [3] - RLS third-party revenue reached $47 million, with a notable increase from zero in Q3 2024 [3] Business Highlights - The company has two FDA-approved PSMA imaging agents, which are expected to enhance market share across various customer segments [4] - Gozellix's reimbursement status is expected to improve production flexibility and customer choice [4] - Telix has commenced commercial launches of Illuccix in multiple European markets, including the UK, Germany, and France [6][15] Clinical Development - The first patients have been dosed in the BiPASS™ trial, which aims to evaluate MRI combined with PSMA-PET imaging for prostate cancer diagnosis [6][15] - The ProstACT Global Phase 3 trial has opened for enrollment in several countries, including Australia, New Zealand, and Canada [7] - TLX250 has received ethics approval to commence a pivotal trial in advanced metastatic clear cell renal cell carcinoma [7] Regulatory and Corporate Updates - Telix has received radiation licenses for its manufacturing facilities in North Melbourne and Yokohama, preparing for operational readiness [12] - The company successfully executed a buy-out of remaining variable payments related to the acquisition of Advanced Nuclear Medicine Ingredients (ANMI) due to strong sales performance [13] - Telix plans to resubmit the New Drug Application for its brain cancer imaging candidate, Pixclara, during Q4 2025 [10]

Core Insights - The U.S. Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through (TPT) payment status for Gozellix®, a next-generation PSMA-PET imaging agent for prostate cancer, marking a significant milestone in Telix's U.S. commercial strategy [1][2] Group 1: Product and Market Impact - Gozellix® will have separate reimbursement under the Hospital Outpatient Prospective Payment System (HOPPS) starting October 1, 2025, and has been assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level II code A9616 [2] - The TPT status will reduce the out-of-pocket burden for patients and enhance access to advanced prostate cancer imaging [5] - Gozellix® offers a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based products, addressing logistical barriers to PSMA-PET imaging [4] Group 2: Production and Technology - The innovative formulation of Gozellix® allows for scalable production via gallium generators or cyclotron-based methods, improving efficiency and scheduling flexibility for scanning clinics [4] - Cyclotron production is supported by GE FASTlab™ and Telix's ARTMS QUANTM Irradiation System® (QIS®), enabling large-scale production across commercial networks and academic centers [4] Group 3: Clinical Application - Gozellix® is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and those with suspected biochemical recurrence based on elevated serum prostate-specific antigen (PSA) levels [3]

Core Insights - Telix Pharmaceuticals Limited is recognized as one of the most oversold healthcare stocks in 2025, focusing on precision oncology and targeted radiotherapies with active clinical programs in prostate cancer and rare oncologic conditions [1] Financial Performance - In the 2025 half-year update, Telix reported a 30% revenue increase in its Precision Medicine segment, driven by strong demand for its PET imaging agent, Illuccix, and the launch of new products like Gozellix, Zircaix, and Pixclara in international markets [2] - The company has expanded its manufacturing capabilities through Telix Manufacturing Solutions to support clinical and commercial operations globally [2] Research and Development - Telix increased its R&D spending by 47% year-over-year to $81.6 million, continuing to invest in its therapeutics pipeline despite being oversold [3] - Key milestones include the completion of target enrollment for the Phase 3 TLX591 trial in advanced metastatic castration-resistant prostate cancer (mCRPC), initiation of a Phase 1 trial for TLX592, and the start of the pivotal IPAX BrIGHT trial for TLX101 in metastatic brain cancer [3][4] - The company also gained IND approval for a Phase 1 study of TLX090 to manage bone pain in osteoblastic metastatic disease [3] Strategic Positioning - Diagnostic growth is further supported by the dosing of the first patient in the pivotal Phase 3 BiPASS trial, aimed at expanding indications for Illuccix and Gozellix in prostate cancer imaging [4] - Telix's dual strategy of commercial expansion and clinical innovation positions it as a leader in radiopharmaceuticals and precision oncology globally [4]