Latest news with #Gozellix
News.com.au
23-04-2025
- Business
- News.com.au
Health Check: Telix shares rocket after bullish quarterly sales update
Telix's quarterly sales reflect first revenue from the company's recent purchase of a US nuclear medicine manufacturer Island Pharma hopes to lift the kimono on its dengue fever trial next month Race Oncology kicks off its cancer-busting, cardioprotective trial Having gleaned all its revenue to date from its US-approved prostate cancer imaging agent Illucix, Telix Pharmaceuticals (ASX:TLX) is starting to reap the benefit of its acquisition of a US nuclear medicine manufacturer. In September last year Telix paid US$230 million for RLS Radiopharmacies, which has 31 nuclear pharmacies dotted across Trumpland. Telix has reported March quarter revenue of US$186 million, 62% higher year on year and 31% up on the December quarter. This includes a robust US$33 million from RLS, which Telix formally acquired on January 27 this year. 'This strategic acquisition has significantly expanded our manufacturing footprint in the US, which we believe is an increasingly important consideration amid changing global trade dynamics,' says Telix chief Dr Chris Behrenbruch. Ah, tariffs! We get it. Illucix sales continue at a decent clip: US$151 million, up 35% year on year. 'Illuccix has continued its momentum, gaining market share and maintaining price stability in a competitive landscape,' Behrenbruch says. Telix has affirmed guidance of full-year (calendar 2025) revenue of US$770-800 million, including eleven months of RLS sales. The guidance is subject to change, given the US Food and Drug Administration (FDA) on March 21 approved Telix's second diagnostic, Gozellix (also for prostate cancer). Telix hopes to launch Gozellix in the US in the current quarter, having appointed RLS and Cardinal Health as distribution partners. Bursting development pipeline Meanwhile, Telix expects FDA approval for its brain imaging candidate Pixclara by the end of this week – April 26. As per the FDA's timetable, the agency should approval Telix's kidney cancer imaging candidate Zircaix by August 27. Investors should expect an initial safety and dosing readout on phase III trial results for Telix's prostate cancer therapy (as opposed to diagnostic) in the current half. Telix also hopes to submit an FDA investigational new drug application for its kidney cancer therapeutics, in view of a late-stage pivotal trial. Adding to Telix's packed agenda, the company has earlier stage programs for a brain cancer therapy (phase II) and advanced, metastatic soft tissue sarcoma (phase I). Telix shares this morning rocketed as much as 15%, but they are still well shy of their February 25 zenith of just over $31. Investors may question just how much of the excitement is factored into Telix's $9.7 billion market capitalisation. Island promises trial results next month Island Pharmaceuticals (ASX:ILA) investors won't have to wait too much longer for results from the second stanza of the company's phase 2a/b dengue fever trial. The 2a phase assessed the preventative qualities of Island's drug candidate ISLA-101 in four undiseased subjects, one of whom was administered a placebo. The drug was deemed safe, with 'evidence of anti-dengue activity". The 2b stage had enrolled ten patients who are administered a weakened form of the virus. Eight of them are administered ISLA-101, with two receiving a placebo. Pharmacokinetic tests showed the drug reached the bloodstream in desired quantities. Next month's results will outline the efficacy. Carried by mosquitos, dengue fever has become a major health problem as it spreads at a rate that makes cane toads look slothful. Race to start cancer trial Race Oncology (ASX:RAC) expects to treat the first patient in its local phase 1 trial that tests its drug candidate RC-220 alongside a common chemotherapy agent. RC-220 is a reformulated version of bisantrene, which was developed as a leukemia drug in France in the 1980s, but was never commercialised for reasons lost in the midst of time. RC-220 shows promise not just for its cancer-busting properties, but its ability to protect the heart from the dire effects of chemotherapy. The trial custodians are treating initial patients at the Southside Cancer Care Centre at Sydney's Miranda. Race has also gained ethics approval to open sites at the Gosford and Wyong hospitals. Race's March quarterly report discloses cash of $17.12 million, with 70% of the $1.67 million quarterly burn devoted to R&D. 'This prudent cash management enables Race to fund all announced clinical and preclinical programs through calendar 2026," the company says. Race costs the circa 53-patient RC-220 trial at $8.58 million. An FDA decision to dye for The latest decision by US health czar Robert F. Kennedy Junior and FDA commissioner Marty Makary could be one of their least controversial. The FDA has banned petroleum-based synthetic dyes from food, as used sweets, soft drinks and other stuff that isn't good for you. Depending on their colour, dyes are thought to be carcinogenic or cause behavioural problems in some children. One of President Biden's last acts in power was to ban an especially controversial red dye from food and ingested drugs, after the additive was found to cause cancer in rats. Technically, the dye no longer is 'generally recognised as safe'.
Associated Press
22-04-2025
- Business
- Associated Press
Telix Reports US$186M Q1 Revenue, Up 62% YOY
MELBOURNE, Australia and INDIANAPOLIS, April 22, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today provides an update on its commercial and operational performance for the quarter ended 31 March 2025 (Q1 2025). All figures are in $US unless stated otherwise. Strong Q1 2025 revenue growth FY 2025 guidance reaffirmed Q1 2025 commentary and recent highlights Telix Managing Director and Group CEO, Dr. Christian Behrenbruch, stated, 'Illuccix has continued its momentum, gaining market share and maintaining price stability in a competitive landscape. Telix is the only company with two FDA4-approved PSMA-PET5 imaging agents – Illuccix and Gozellix – enabling us to broaden patient reach and maximize choice for our customers. The expansion of our commercial portfolio and launches of Illuccix into new international markets provides a foundation to diversify and grow revenue globally, while we continue to deliver on multiple catalysts in our pipeline. This quarter also includes the first two months of revenue from RLS since completion of our acquisition, highlighting its potential as a platform to drive further growth. This strategic acquisition has significantly expanded our manufacturing footprint in the U.S., which we believe is an increasingly important consideration amid changing global trade dynamics.' Therapeutics business Precision Medicine business Telix Manufacturing Solutions (TMS) Board renewal Telix announced new Director appointments as part of a Board succession planning and renewal process18: Guidance disclaimer The stated revenue guidance is based on expected global and domestic economic conditions and is subject to known and unknown risks, uncertainties and other factors that may cause our actual results to differ materially. As such, investors are cautioned not to place undue reliance on this guidance and in particular Telix cannot guarantee a particular result. In compiling financial forecasts, a number of key variables that may have a significant impact on guidance have been identified and are listed below. Key variables that could cause actual results to differ materially include: the success and timing of research and development activities; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; competitive developments affecting our products; the ability to successfully market new and existing products; difficulties or delays in manufacturing; trade buying patterns and fluctuations in interest and currency exchange rates; legislation, regulation, or policy that affects product production, distribution, pricing, reimbursement, access or tax; acquisitions and divestitures; research collaborations; litigation or government investigations; and Telix's ability to protect its patents and other intellectual property. See the Legal Notices section below for additional information, risks and assumptions. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX). Telix's prostate imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the FDA19, the Australian Therapeutic Goods Administration (TGA)20, Health Canada21, the UK Medicines and Healthcare Products Regulatory Agency (MHRA)22, by the Brazilian Health Regulatory Agency (ANVISA)23, and in multiple countries within the European Economic Area (EEA)24. Illuccix® is currently in national approval review elsewhere in the EEA following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM25. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the FDA26. Telix's osteomyelitis (bone infection) imaging agent, technetium-99m (99mTc) besilesomab, marketed under the brand name Scintimun®, is approved in 32 European countries and Mexico. Telix's miniaturized surgical gamma probe, SENSEI®, for minimally invasive and robotic-assisted surgery, is registered with the FDA for use in the U.S. and has attained a Conformité Européenne (CE) Mark for use in the European Economic Area. No other Telix product has received a marketing authorization in any jurisdiction. Visit for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook. Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Investor Relations and Corporate Communications Email: [email protected] Telix Investor Relations (U.S.) Annie Kasparian Telix Pharmaceuticals Limited Director Investor Relations and Corporate Communications Email: [email protected] This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. Legal Notices You should read this announcement 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 announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as 'may', 'expect', 'intend', 'plan', 'estimate', 'anticipate', 'believe', 'outlook', 'forecast' and 'guidance', or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix's product candidates, manufacturing activities and product marketing activities; Telix's sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix's product candidates, if or when they have been approved; Telix's ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix's business; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. ©2025 Telix Pharmaceuticals Limited. Telix Pharmaceuticals, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country. ______________________________________________ 1 Excludes revenue contribution from Illuccix® sales. 2 Refer to ASX disclosures 20 February 2025. 3 See Guidance Disclaimer for further information. 4 U.S. Food and Drug Administration. 5 Imaging of prostate-specific membrane antigen with positron emission tomography. 6 Telix ASX disclosure 16 April 2025. 7 Telix media release 1 April 2025. ID: NCT06537596. 8 Fibroblast activation protein. 9 Telix ASX disclosure 13 January 2025. 10 Telix media release 13 March 2025. 11 Telix ASX disclosure 21 March 2025. 12 Telix media release 8 April 2025. 13 Telix ASX disclosure 17 March 2025. 14 Illuccix® received marketing authorization in the UK, Brazil, Denmark, Luxembourg, Malta, the Netherlands and Norway during Q1 2025. Illuccix® received marketing authorization in Ireland and Sweden on 4 and 11 April 2025, respectively. 15 Brand name subject to final regulatory approval. 16 Prescription Drug User Fee Act. 17 Telix ASX disclosure 7 April 2025. 18 Telix ASX disclosure 26 February 2025. 19 Telix ASX disclosure 20 December 2021. 20 Telix ASX disclosure 2 November 2021. 21 Telix ASX disclosure 14 October 2022. 22 Telix ASX disclosure 13 February 2025. 23 Telix ASX disclosure 18 March 2025. 24 Denmark, Ireland, Luxembourg, Malta, the Netherlands, Norway and Sweden at time of release. 25 Telix ASX disclosure 17 January 2025. 26 Telix ASX disclosure 21 March 2025.
Yahoo
21-03-2025
- Business
- Yahoo
FDA Approves New Prostate Cancer Imaging Agent Gozellix®
MELBOURNE, Australia and INDIANAPOLIS, March 21, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Gozellix® (TLX007-CDx, kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix's next-generation PSMA-PET imaging[1] agent for prostate cancer. Gozellix®, after radiolabeling with 68Ga, is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Gozellix® is a novel product which provides a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based imaging products. The ability to reliably deliver the product much further from its point of production means Gozellix® can reach PET cameras that are currently not served by any PSMA imaging providers, bringing the accuracy and clinical utility of gallium-based imaging to more patients across the U.S. The innovative formulation, which allows for more scalable production, also has the potential to enhance the efficiency, scheduling flexibility and throughput of scanning clinics. Gozellix® builds on the success of Telix's established PSMA-PET imaging agent, Illuccix®, and will be available alongside the first-generation product, providing choice for customers and patients based on their individual needs. In the U.S., the accuracy and sensitivity of PSMA-PET imaging means it has become the standard of care for prostate cancer imaging after initial diagnosis and biochemical recurrence[2]. However, only a relatively small fraction of the 3.4 million men living with prostate cancer in the U.S. have undergone this type of precision medicine scan[3],[4]. Telix believes Gozellix® will help to address these access issues, as it is expected to be eligible for full reimbursement[5] with reduced or no patient co-insurance, meaning it can reach more patients, particularly in underserved populations. Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, said, "Securing FDA approval for Gozellix is a major win for prostate cancer patients, who gain enhanced access to state-of-the-art 68Ga PSMA-PET imaging. Telix continues to invest in innovation across our portfolio, and Gozellix is a testament to this continuous improvement approach. With the launch of Gozellix, our team is excited to be bringing the new generation of prostate cancer scanning to more American men, delivered with the reliability, service and flexibility that customers have come to expect from Telix." IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Risk for Misinterpretation Image interpretation errors can occur with GOZELLIX PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga-68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget's disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended. Imaging Prior to Initial Definitive or Suspected Recurrence Therapy The performance of GOZELLIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of GOZELLIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Radiation Risks Gallium Ga-68 gozetotide contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration. Hypersensitivity Reactions to Sulfites Ascorbic Acid Stabilizer contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. ADVERSE REACTIONS The safety of gallium Ga-68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMABCR studies, each receiving one dose of gallium Ga-68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%. DRUG INTERACTIONS Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga-68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga-68 gozetotide PET has not been established. Please note that this information is not comprehensive. Please see the Full Prescribing Information here. You are encouraged to report suspected adverse reactions of prescription drugs to the FDA. Visit MedWatch at or call 1-800-FDA-1088. You may also report adverse reactions to Telix Pharmaceuticals (US) by calling 1-844-455-8638 or emailing pharmacovigilance@ About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (Nasdaq: TLX). Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix's first generation PSMA-PET imaging agent, has been approved by the U.S. FDA[6], by the Australian Therapeutic Goods Administration (TGA)[7], by Health Canada[8], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)[9], by the Brazilian Health Regulatory Agency (ANVISA)[10], and in multiple countries within the European Economic Area (EEA)[11] following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM[12]. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA[13]. Visit for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook. Telix Investor Relations Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: This announcement has been authorized for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. Legal Notices You should read this announcement 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 announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "believe", "outlook", "forecast" and "guidance", or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical trials, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix's product candidates, manufacturing activities and product marketing activities; Telix's sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix's product candidates, if or when they have been approved; Telix's ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. ©2025 Telix Pharmaceuticals Limited. Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country. [1] Imaging of prostate-specific membrane antigen with positron emission tomography.[2] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.4.2024.[3] NIH Common Cancer Sites — Cancer Stat Facts. Accessed May 2024.[4] Company analysis based on proprietary and public domain data.[5] Hospital Outpatient Prospective Payment System (OPPS) patients eligible for reimbursed PSMA-PET scanning.[6] Telix ASX disclosure 20 December 2021.[7] Telix ASX disclosure 2 November 2021[8] Telix ASX disclosure 14 October 2022.[9] Telix ASX disclosure 13 February 2025.[10] Telix ASX disclosure 18 March 2025.[11] Denmark, Luxembourg, Malta, the Netherlands and Norway at time of release.[12] Telix ASX disclosure 17 January 2025.[13] Telix ASX disclosure 21 March 2025. View original content to download multimedia: SOURCE Telix Pharmaceuticals Limited Sign in to access your portfolio
