Core Viewpoint - Telix Pharmaceuticals has submitted a marketing authorization application (MAA) in Europe for TLX101-Px, an imaging candidate for glioma, aiming to enhance patient access to advanced brain imaging [1][2]. Group 1: Regulatory Submission - The European submission for TLX101-Px was expedited to align with the U.S. FDA package, covering major European markets [2]. - A New Drug Application (NDA) for TLX101-Px will follow the European submission [2]. Group 2: Clinical Need and Product Development - There is currently no commercially available product in Europe for glioma imaging that ensures consistent quality and access, highlighting an acute need for TLX101-Px [3][5]. - TLX101-Px aims to differentiate between progressive glioma and treatment-related changes, with potential future indications [3]. - TLX101-Px is also being developed as a tool for patient selection and response assessment for Telix's glioblastoma therapy candidate TLX101-Tx, which is in Phase 3 trials [3]. Group 3: Market Context - Approximately 67,500 brain and central nervous system tumors are diagnosed annually in Europe, with gliomas making up about 30% of these cases [5]. - Gliomas are the most common primary brain tumors, and there is a critical need for improved diagnosis and management, especially in post-treatment settings [5]. Group 4: Product Characteristics - TLX101-Px targets L-type amino acid transporters (LAT1 and LAT2) and is intended to be a complementary diagnostic agent to TLX101-Tx [6]. - The proposed brand name for TLX101-Px in relevant European markets is "Pixlumi®," pending regulatory approval [7]. Group 5: Company Overview - Telix Pharmaceuticals is focused on developing and commercializing therapeutic and diagnostic radiopharmaceuticals, with operations in multiple countries including Australia, the U.S., and Europe [8].

MELBOURNE, Australia and INDIANAPOLIS, Feb. 04, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) advises that it will release its full year results for the period ended 31 December 2025 on Friday, 20 February 2026 AEDT (Thursday, 19 February 2026 EST). An investor webcast and conference call will be held at 9:30 a.m. AEDT, Friday, 20 February 2026 (5:30 p.m. EST, Thursday, 19 February 2026). Participants can register at the following link: https://edge.media-server.com ...

Core Insights - Telix Pharmaceuticals reported fiscal 2025 revenue of approximately $804 million, meeting its upgraded guidance of $800-$820 million [1] - The company experienced a significant 46% year-over-year increase in fourth quarter revenue, totaling around $208 million [2] - The Precision Medicine business generated approximately $161 million in revenue, reflecting a 4% quarter-over-quarter growth driven by the successful U.S. launch of Gozellix [2] Financial Performance - Fiscal 2025 revenue was approximately $804 million, aligning with guidance [1] - Fourth quarter revenue increased by 46% year-over-year to around $208 million [2] - Precision Medicine revenue was approximately $161 million, with a 4% quarter-over-quarter growth [2] Clinical Advancements - The company is advancing clinical studies, including the ProstACT Global Phase 3 study and the SOLACE Phase 1 study in the U.S. [3] - Telix dosed the first patient in the U.S. for the BiPASS Phase 3 trial to evaluate its PSMA-PET imaging agents [4] Strategic Collaborations - Telix announced a strategic collaboration with Varian to explore the combination of its radiopharmaceuticals with external beam radiation therapy [5] Stock Performance - Telix stock is currently trading 5.5% below its 20-day simple moving average and 22.6% below its 100-day SMA, indicating a bearish trend [6] - Over the past 12 months, shares have decreased by 56.91% [6] - The stock carries a Buy Rating with an average price target of $21.20, despite trading at a premium P/E multiple [8] Analyst Insights - Analysts view the shift from a diagnostic-focused business to a pure-play radiopharmaceutical company as a positive development [9] - The bull case for Telix is based on the potential for durable cash flows from Illuccix and Gozellix [9] Market Position - Telix Pharmaceuticals' Benzinga Edge scorecard indicates a challenging outlook, with low momentum and a premium value score [10] - The stock was down 6.86% at $7.20 at the time of publication [11]

Group 1 - U.S. stock futures showed mixed results, with Dow futures declining approximately 0.1% [1] - Netflix reported fourth-quarter financial results that exceeded expectations but provided first-quarter guidance that fell short of estimates, leading to a significant drop in its stock price [2] - Netflix anticipates first-quarter revenue of $12.16 billion, slightly below the consensus estimate of $12.19 billion, and expects earnings per share of 76 cents, which is below the consensus estimate of 81 cents [2] Group 2 - Erasca Inc shares fell 6.2% to $9.20 following the announcement of a proposed public offering of $150 million [3] - Telix Pharmaceuticals experienced a 5.8% decline to $7.28, despite an analyst maintaining a Buy rating with a $20 price target [3] - Corvus Pharmaceuticals saw a 5.6% drop to $20.22 after commencing a $150 million offering of common shares and pre-funded warrants [3] - BIOAGE Labs Inc shares decreased by 5.6% to $20.13 after announcing a $75 million stock offering [3] - Kraft Heinz Co shares fell 5.3% to $22.51 after Berkshire Hathaway filed to sell up to 325 million shares of the company [3] - NovaBay Pharmaceuticals Inc shares dropped 5.2% to $6.16, following a 56% decline on Tuesday due to a $100 million ATM equity program announcement [3] - Okeanis Eco Tankers Corp shares decreased by 4.8% to $37.00 in pre-market trading [3]

MELBOURNE, Australia and INDIANAPOLIS, Jan. 20, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) provides an update on its commercial and operational performance for the quarter ended 31 December 2025 (Q4 2025). Q4 2025 Highlights Full-year (FY) 2025 unaudited Group revenue of approximately US$804 million (A$1.2 billion1), in line with upgraded guidance of US$800-$820 million2 (previously US$770-800 million).Q4 2025 unaudited Group revenue of approximately US$208 mill ...

Core Viewpoint - Telix Pharmaceuticals has initiated the BiPASS™ Phase 3 trial in the U.S. to evaluate the effectiveness of its PSMA-PET imaging agents, Illuccix® and Gozellix®, in improving prostate cancer diagnosis and reducing unnecessary biopsies [1][2][4]. Group 1: BiPASS™ Trial Overview - BiPASS™ is the first study aimed at obtaining marketing authorization for Ga-PSMA-PET imaging in the pre-biopsy setting, enrolling 250 patients across the U.S. and Australia [2][3]. - The trial seeks to determine if combining MRI with Illuccix/Gozellix can enhance diagnostic accuracy and minimize unnecessary biopsies compared to current practices [2][3]. Group 2: Prostate Biopsy Context - Over one million prostate biopsies are conducted annually in the U.S., with up to 75% yielding negative results, and one in four patients opting out of the procedure [3]. - The BiPASS™ study aims to improve lesion detection and patient stratification by integrating non-invasive imaging early in the diagnostic process, potentially leading to fewer biopsies or more precise ones [3][4]. Group 3: Potential Impact - If successful, the BiPASS™ study could significantly reduce unnecessary biopsies, enhance patient experience, and broaden access to precision imaging for suspected prostate cancer patients [4][5]. - The trial aligns with Telix's commitment to clinical innovation and patient-centric approaches, aiming to eliminate invasive biopsy procedures [5]. Group 4: Company Background - Telix Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing therapeutic and diagnostic radiopharmaceuticals, headquartered in Melbourne, Australia, with operations in multiple countries [23]. - The company is developing a portfolio of products to address unmet medical needs in oncology and rare diseases, with Illuccix and Gozellix already transforming prostate cancer management [23][24].

Company Overview - Telix is an increasingly recognized company in the radiopharmaceutical space, focusing solely on oncology and radiopharmaceuticals with a precision medicine-oriented approach [2][3] - The company is vertically integrated, which allows it to control various aspects of its operations in the radiopharma sector [2] Product Development Strategy - Telix develops both imaging agents and therapeutic agents for each target, leveraging the valuable signals obtained from radiopharmaceuticals to understand efficacy and improve delivery [3][4] - This dual approach of combining imaging and therapeutic capabilities has proven beneficial for the company's commercial trajectory [4]

Summary of Telix Pharmaceuticals FY Conference Call Company Overview - **Company**: Telix Pharmaceuticals (NasdaqGS:TLX) - **Industry**: Radiopharmaceuticals, specializing in oncology - **Focus**: Precision medicine approach in radiopharmaceuticals, developing both imaging agents and therapeutics for cancer treatment [4][5] Core Points and Arguments Commercial Strategy and Growth - Telix has invested approximately **$500 million** in manufacturing, supply chain, and distribution capabilities over the last two years [6] - The company has expanded its commercial presence into **17 countries** outside the U.S., including Europe, the U.K., and Brazil, with plans for further expansion in China and Japan [7][8] - The lead commercial product, **Illuccix**, has seen significant success, with a new drug approval in April and a pass-through reimbursement effective from October [8][10] - Financial guidance for the full year is projected between **$800 million and $820 million**, with expectations for continued growth over the next two to three years [10] Product Pipeline and Development - Telix is focusing on three therapeutic programs in **Phase 3 trials** this year, including **Pixclara** and **Zircaix**, with resubmissions expected to proceed as planned [12][22] - The company is also expanding indications for existing products, particularly in prostate cancer, which has a total addressable market (TAM) of approximately **$3 billion** [14] - A new **bypass biopsy study** aims to optimize patient selection for biopsies, potentially reducing unnecessary procedures and increasing market opportunities [16][54] Manufacturing and Supply Chain - Telix has established a nuclear pharmacy network in the U.S. and has delivered **150,000 doses** of Illuccix and Gazelix last year, contributing to a total of **2.9 million doses** across all operating segments [20] - The company is building GMP manufacturing capabilities in the U.S., Europe, and Japan, enhancing its global footprint [19] Regulatory Engagement and Challenges - The company has faced challenges with the FDA regarding manufacturing and comparability issues, particularly with **Zircaix**, but is optimistic about upcoming meetings and resubmissions [42][44] - There is a focus on integrating radioligand therapy into standard care, addressing the need for clinical infrastructure and practitioner training [45][47] Future Outlook - Telix aims to surpass **$1 billion** in revenue, with a strategy focused on reinvesting commercial revenue into pipeline and infrastructure development [21][22] - The company is positioning itself as a self-funded biotech, emphasizing the importance of pipeline expansion and therapeutic innovation [22][23] - Upcoming milestones include the readout of Phase 3 data for TLX-591 and the resubmission of Pixclara and Zircaix, which are expected to drive significant value creation [37][38] Additional Important Insights - The company is exploring in-house innovation capabilities to develop new isotopes and biologic-centric innovations [24] - Telix is committed to addressing the pharmacoeconomic benefits of its products, aiming to improve patient outcomes and reduce healthcare costs [16][54] - The competitive landscape in radiopharmaceuticals is evolving, with Telix focusing on differentiating its products and maintaining commercial leadership through lifecycle management strategies [15][36]

This presentation should be read together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website. The information contained in this presentation is not intended to be an offer for subscription, invitation or recommendation with respect to shares of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the U ...

Core Viewpoint - A class action securities lawsuit has been filed against Telix Pharmaceuticals Ltd. alleging securities fraud that affected investors between February 21, 2025, and August 28, 2025 [1][2]. Group 1: Lawsuit Details - The complaint claims that defendants made false statements regarding Telix's progress with prostate cancer therapeutic candidates, overstated the quality of its supply chain and partners, and that these statements were materially false and misleading [2]. - Investors who suffered losses during the specified timeframe have until January 9, 2026, to request to be appointed as lead plaintiff, although participation in any recovery does not require serving as lead plaintiff [3]. Group 2: Legal Representation - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions of dollars for shareholders and being recognized as one of the top securities litigation firms in the United States for seven consecutive years [4].