Aankondiging • May 21
Telix Pharmaceuticals Limited Completes Enrolment and Confirms Dosing in Ipax-2 Study of Tlx101-Tx in First-Line Glioblastoma Telix Pharmaceuticals Limited announced that the IPAX-2 study of TLX101-Tx (¹³¹I-iodofalan) in patients with newly diagnosed glioblastoma has completed patient enrolment. No dose-limiting toxicities (DLTs) have been observed to date, including with two doses of 5GBq (total administered activity of 10GBq), the maximum administered dose in the study. IPAX-2 is an international, multicenter, open-label Phase 1 dose finding study to evaluate the safety and tolerability of TLX101-Tx in combination with post-surgical standard-of-care treatment (external beam radiation therapy and temozolomide) in primary glioblastoma. Twelve patients were enrolled into three dose escalating cohorts across four sites in Australia, Austria and the Netherlands to assess the safety and tolerability, and to assess the maximum tolerated dose (MTD) for further development. Patients remain on standard-of-care treatment until study completion, after which the MTD primary endpoint will be confirmed. TLX101-Tx is currently also under evaluation in the pivotal IPAX BrIGHT trial to assess the safety and efficacy of TLX101-Tx in combination with chemotherapy (lomustine), compared to chemotherapy alone in patients with recurrent glioblastoma (last line). IPAX BrIGHT is actively enrolling and dosing patients in Australia and the Netherlands and is also approved in Austria and Belgium with enrollment to begin soon. This marks the first radiopharmaceutical therapy to enter Phase 3 development for glioblastoma. Telix's PET imaging candidate TLX101-Px (floretyrosine F 18) has been used across the IPAX series of trials to identify participants with overexpressed LAT1 as suitable candidates for TLX101-Tx therapy, and to provide baseline and follow-up information on tumor response and progression. TLX101-Tx (¹³¹I-iodofalan) is a systemically administered radiopharmaceutical therapy that targets L-type amino acid transporter 1 (LAT1), which is typically over-expressed in glioblastoma. TLX101-Tx utilizes a small molecule approach due to the need to cross the blood brain barrier, the normal protective barrier that prevents many potential drug candidates entering the brain. In addition to IPAX-2, TLX101-Tx was also the subject of the IPAX-1 study in recurrent glioblastoma, which reported a median overall survival (OS) of 13 months from the initiation of treatment with TLX101-Tx, or 23 months from initial diagnosis. Preliminary results from the IPAX-Linz investigator-initiated trial of TLX101-Tx in the recurrent setting were consistent and confirmatory to IPAX-1, with a median OS of 11.9 months from the relapse prior to trial enrollment and 32.2 months from initial diagnosis. Beyond the clinical trial setting, an early access program for TLX101-Tx in Europe has dosed 18 patients at first recurrence or later, further establishing the clinical utility of TLX101-Tx. TLX101-Tx has received orphan drug designation in the U.S. and Europe for the treatment of glioma. TLX101-Tx and TLX101-Px have not received a marketing authorization in any jurisdiction and are for investigational use only. Board Change • May 20
Less than half of directors are independent There is 1 new director who has joined the board in the last 3 years. The new board member was an independent director. The company's board is composed of: 1 new director. 9 experienced directors. 2 highly experienced directors. 3 independent directors (4 non-independent directors). Independent Non-Executive Director Marie McDonald was the last independent director to join the board, commencing their role in 2025. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. Aankondiging • May 05
Telix Pharmaceuticals Limited Announces New Analysis of Tlx250-Px (Zircaix) Phase 3 Zircon Trial Data Telix Pharmaceuticals Limited announced the publication of a new independent analysis of Phase 3 ZIRCON trial data in European Urology, demonstrating that TLX250-Px (Zircaix, 89Zr-girentuximab) PET/CT imaging may be highly predictive of renal malignancy across all subtypes, not limited to clear cell renal cell carcinoma (ccRCC). Recognizing that carbonic anhydrase IX (CAIX) expression is also observed in other renal cancer subtypes, this subsequent analysis conducted by international investigators who participated in ZIRCON Phase 3 trial evaluated centrally reviewed imaging and pathology data to explore whether tracer uptake in renal masses correlated with malignancy beyond ccRCC. The analysis demonstrated that positive PET findings were highly predictive of malignancy overall, including in non-clear cell renal cell carcinoma (nccRCC), with a reported positive predictive value (PPV) of 98% (95% CI, 96–99), sensitivity of 82% (95% CI, 82–90), and specificity of 87% (95% CI, 81–93). These exploratory scientific findings suggest TLX250-Px has applications beyond the detection of ccRCC in primary renal masses and may have implications to management of nccRCC. These findings are based on exploratory analyses and were not the basis of Telix’s Biologics License Application (BLA) submission for TLX250-Px, which focuses exclusively on detection of ccRCC in primary renal masses. TLX250-Px is a PET imaging candidate under development for the diagnosis and characterization of ccRCC, and included in international guidelines for renal imaging. It works by specifically binding to carbonic anhydrase IX (CAIX), a validated target protein expressed on >95% of ccRCC cells, to produce images with high tumor-to-background ratio and high intra- and inter-reader consistency. Telix's pivotal Phase 3 ZIRCON trial evaluating TLX250-Px in 300 patients, of whom 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% positive predictive value (PPV) for ccRCC across three independent radiology readers. ZIRCON-X, a noninterventional, prospective, post hoc study using imaging data from ZIRCON, found that almost half of all patients (48.6%) would have undergone a change in clinical management if imaged with TLX250-Px, compared with baseline standard-of-care (SOC) imaging, and that more than 20% could potentially have avoided an invasive biopsy. TLX250-Px has not received a marketing authorization in any jurisdiction. Aankondiging • May 02
Telix Pharmaceuticals Limited Presents Initial Dosimetry Data For TLX597-Tx In Prostate Cancer Telix Pharmaceuticals Limited announced dosimetry results from the randomized Phase 2 OPTIMAL-PSMA trial of TLX597-Tx in metastatic castration-resistant prostate cancer (mCRPC), presented at the 2026 International Prostate Cancer Symposium (IPCS 2026) held in Lugano, Switzerland. TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA) is a novel PSMA-targeting small molecule radioligand therapy (RLT) candidate with a highly favorable dosimetry profile. Significantly reduced radiation exposure to healthy organs, including the salivary glands and kidneys, may lower the incidence of xerostomia (dry mouth) and renal toxicity and support better tolerability for patients. This dosimetry profile combined with higher tumor uptake compared to existing PSMA RLTs may deliver a wider therapeutic window and enable dose intensification to maximize tumor control while preserving patient quality-of-life. OPTIMAL-PSMA is an open-label, multi-center, randomized, Phase 2 investigator-initiated trial (IIT) led by Professor Louise Emmett at St Vincent’s Hospital in Sydney, Australia. The study is evaluating the safety, dosimetry, and efficacy of an intensified dosing regimen of TLX597-Tx compared with a standard dose schedule in 120 men with advanced mCRPC, randomized on a 2:1 basis. The novel dose-intensification regimen delivers higher activity per cycle (8.5 GBq), delivered on day 1, day 3 and day 15, followed by 10-weekly dosing for three further cycles. The study aims to confirm that a dose intensified TLX597-Tx regimen will maximize the radiation dose to cancerous lesions when they are most vulnerable to damage and therefore improve overall response to treatment. Telix is developing two distinct prostate therapeutic programs, tailored to disease stage and patient condition: TLX591-Tx radio antibody-drug conjugate (rADC) in combinations with standard of care (Phase 3 in mCRPC) and TLX597-Tx intended for earlier-stage mHSPC. TLX597-Tx is being developed alongside TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan), Telix’s lead antibody-based prostate cancer therapy candidate, currently the subject of the Phase 3 ProstACT Global trial in mCRPC, which is actively dosing patients in jurisdictions with regulatory approval and recently reported data from a safety and dosimetry lead-in. TLX591-Tx and TLX597-Tx exhibit complementary modes-of-action, suggesting the potential for distinct applications in mCRPC and mHSPC settings as part of Telix’s portfolio approach to treating prostate cancer. TLX591-Tx and TLX597-Tx have not received marketing authorization in any jurisdiction. Aankondiging • Apr 22
Telix Pharmaceuticals Limited, Annual General Meeting, May 21, 2026 Telix Pharmaceuticals Limited, Annual General Meeting, May 21, 2026. Location: at the events centre, level 5, tower 2/727 collins street, meetings.openbriefing.com/tlxagm2026, melbourne, victoria 3008 Australia Aankondiging • Apr 15
Telix Pharmaceuticals Limited Doses First Patient in Phase 3 Ipax-Bright Trial of Tlx101-Tx for Recurrent Glioblastoma Telix Pharmaceuticals Limited announced that the first patient has been dosed with TLX101-Tx (I-iodofalan) in Telix’s pivotal IPAX BrIGHT trial, marking the first radiopharmaceutical therapy to enter Phase 3 development for glioblastoma, an aggressive form of brain cancer. The patient was dosed at Austin Health in Melbourne, Australia, under the supervision of Professor Hui Gan. IPAX BrIGHT is assessing the safety and efficacy of TLX101-Tx in combination with chemotherapy (lomustine), compared to chemotherapy alone. The global, multicenter, open-label study will enroll patients with radiographically confirmed recurrent glioblastoma at first recurrence.Telix’s commitment to advancing care for patients with glioblastoma is driven by the significant unmet need in this space. In the past 25 years, only two drugs have been approved by the United States Food and Drug Administration (FDA) for glioblastoma, and no standard treatment currently exists for recurrent disease. Patients therefore face limited treatment options after initial therapy. TLX101-Tx offers a novel approach by targeting the L-type amino acid transporter 1 (LAT1), a transporter that enables the radiopharmaceutical to cross the blood-brain barrier and delivers therapy directly to the tumor. IPAX BrIGHT expands upon promising data from earlier trials in the recurrent glioblastoma setting, including IPAX-1, which reported a median overall survival (OS) of 13 months from the initiation of treatment with TLX101-Tx, or 23 months from initial diagnosis. Preliminary results from the IPAX-Linz investigator-initiated trial of TLX101-Tx were consistent and confirmatory to IPAX-1, with a median OS of 12.4 months from initiation of treatment and 32.2 months from initial diagnosis. Beyond the clinical trial setting, an early access program for TLX101-Tx in Europe has dosed 18 patients at first recurrence or later, further establishing the clinical utility of TLX101-Tx. The IPAX BrIGHT study has received regulatory approval in Australia, Austria, Belgium and the Netherlands with approval being sought in additional jurisdictions. Telix’s investigational PET imaging agent for glioma, TLX101-Px (floretyrosine F 18) will be used for patient selection in IPAX BrIGHT, as well as assessing metabolic tumor response according to PET RANO 1.0. Aankondiging • Apr 11
Telix Pharmaceuticals Limited Announces FDA Acceptance Of Resubmitted New Drug Application For TLX101-Px1 (Pixclara®) Telix Pharmaceuticals Limited announced that the United States Food and Drug Administration (FDA) has accepted the Company’s resubmitted New Drug Application (NDA) for TLX101-Px (Pixclara, Floretyrosine F 18 or 18F-FET), an investigational PET agent for the imaging of glioma (brain cancer), and has assigned a PDUFA goal date of September 11, 2026. The approval of TLX101-Px will fulfil a significant unmet medical need for the characterization of recurrent or progressive glioma from treatment related changes in both adult and pediatric patients. Neuroimaging of glioma with 18F-FET is already broadly recommended in international clinical practice guidelines – including NCCN Guidelines – and TLX101-Px has been granted Orphan Drug and Fast Track designations by the FDA. Aankondiging • Apr 09
Telix Pharmaceuticals Limited Announces Board Appointments, Effective May 11, 2026 Telix Pharmaceuticals Limited announced two additional Non-Executive Director appointments, effective May 11, 2026, as part of Board expansion and succession planning. Maria Rivas, MD is an experienced public company board director and S&P 100 senior pharmaceutical executive with more than 25 years’ experience in late-stage clinical development, commercialization and governance leadership. Dr. Rivas currently serves on the board of directors of The Cooper Companies Inc., and also served as an independent director for Medidata from 2018-2019 until its successful merger with Dassault Systèmes. Dr. Rivas spent over 25 years in healthcare developing and commercializing medical devices and pharmaceutical products across multiple therapeutic areas including oncology, rare diseases and neurosciences, most recently as Chief Medical Officer at Pfizer Inc. She has managed global operations of several thousand data scientists, healthcare experts and field staff, and overseen the launch of multiple blockbuster medical products. Dr. Rivas holds a B.A. in Biochemistry from Brandeis University and an MD from Columbia University’s Vagelos College of Physicians and Surgeons. She completed residency training in Internal Medicine and a fellowship in Endocrinology at New York-Presbyterian Hospital. William (Bill) Jellison is a public company director and corporate finance leader with over 30 years’ experience, including audit committee leadership in large, regulated operating environments. He currently serves on the board of directors of Medtronic plc, Anika Therapeutics Inc., Avient Corporation, Solenis LLC, and Young Innovations Inc., and until recently served as a director of Masimo Corporation. During his executive career, Mr. Jellison most recently served as Vice President and CFO of Stryker Corporation, overseeing international finance, SEC reporting, mergers and acquisitions, and capital allocation. He holds a B.A. in Business Administration from Hope College. Aankondiging • Apr 07
Telix Pharmaceuticals Limited Reaffirms Earnings Guidance for the Fiscal Year 2026 Telix Pharmaceuticals Limited reaffirmed earnings guidance for the fiscal year 2026. For the year, the company reaffirmed revenue guidance of USD 950 million to USD 970 million. Guidance reflects revenue from product sales in jurisdictions with a marketing authorization, and a full year of revenue contribution from RLS. Aankondiging • Apr 02
Telix Pharmaceuticals Limited Appoints David Gill as Non-Executive Director, Effective May 11, 2026 Telix Pharmaceuticals Limited announced the appointment of David Gill as a Non-Executive Director (NED), as part of Board expansion and succession planning. The appointment is effective May 11, 2026. Mr. Gill is expected to be appointed as Chair in due course, succeeding Dr. Mark Nelson who will remain on the Board as a NED.Mr. Gill is a life sciences executive with over 35 years’ experience in senior general management and financial leadership roles across commercial and clinical-stage biopharmaceutical (including radiopharmaceuticals) and medical device companies. He currently serves on the boards of Evolus Inc., Allucent LLC, Bridge to Life Ltd, RapidPulse Inc. and huMannity Medtec (formerly Alfred Mann Foundation), and was until recently a board member of Y-mAbs Therapeutics Inc., Strongbridge Biopharma plc, Alpha Source Inc, Healthtronics, Inc, and Perimetrics, LLC.Mr. Gill brings deep expertise in capital markets, scaling businesses, governance and corporate turn-around strategy and has served as Chief Financial Officer or President of multiple publicly traded companies, including EndoChoice Holdings Inc. (acquired by Boston Scientific), INC Research (now Syneos Health), and CTI Molecular Imaging (acquired by Siemens). He holds a B.S. in Accounting from Wake Forest University and an MBA from Emory University. Aankondiging • Mar 16
Telix Pharmaceuticals Limited Resubmits Nda for Tlx101-Px Brain Cancer Imaging Candidate Telix Pharmaceuticals Limited announced the resubmission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for TLX101-Px, (Pixclara, Floretyrosine F 18 or 18F-FET), an investigational PET imaging agent for the characterization of recurrent or progressive glioma (brain cancer) from treatment related changes in both adult and pediatric patients. Telix has resubmitted the NDA with the additional data requested by the FDA. The Company believes, based on the Type A meeting and ongoing consultation with the FDA, that the additional data and statistical analysis, along with the primary data set provided in the original submission, appropriately addresses the Complete Response Letter. Given the potential to address significant unmet medical need, TLX101-Px has been granted Orphan Drug and Fast Track designations by the FDA. PET imaging with 18F-FET is already included in international clinical practice guidelines for the imaging of gliomas, however there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.S. TLX101-Px is a PET imaging agent, which has been granted fast track and orphan drug designations by the FDA as an imaging agent for the characterization of recurrent or progressive glioma from treatment related changes. TLX101-Px targets membrane transport proteins known as LAT1 and LAT2. This enables TLX101-Px to be potentially utilized as a companion diagnostic agent to TLX101-Tx (iodofalan 131I), Telix’s LAT1-targeting glioblastoma (GBM) therapy candidate, currently under investigation in the pivotal IPAX-BrIGHT study. Aankondiging • Mar 10
Telix Pharmaceuticals Limited Achieves Primary Objectives In Prostact Global Phase 3 Study Part 1 Telix Pharmaceuticals Limited announced that Part 1 of the ProstACT Global Phase 3 study, the safety and dosimetry lead-in for its therapeutic candidate – TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) – has achieved its primary objectives, demonstrating an acceptable safety and tolerability profile with no new safety signals observed. Key findings include: Tolerability profile supported by dosimetry and low-grade non-hematologic events. Lesion dosimetry indicates no difference in absorbed dose profile across cohorts. No adverse drug-drug interactions observed in TLX591-Tx combinations. Hematologic events are in line with expectations and transient and manageable, with similar rates of recovery across all patient cohorts. The results from Part 1 are consistent with prior clinical studies of this first-in-class lutetium radio antibody-drug conjugate (rADC) therapy. Part 1 of the study confirmed the safety profile, biodistribution and dosimetry of TLX591-Tx administered in two doses, 14 days apart, in combination with one of three standard of care (SOC) therapies: abiraterone, enzalutamide or docetaxel. The patient population comprised prostate-specific membrane antigen (PSMA) positive metastatic castration resistant prostate cancer (mCRPC) patients previously treated with one androgen receptor pathway inhibitor (ARPI). ProstACT Global is a differentiated Phase 3 trial comparing PSMA-targeted 177Lu-rADC therapy administered with SOC versus SOC alone, a trial design intended to reflect current global clinical practice. Telix has already advanced the study into Part 2 – a 2:1 randomized treatment expansion – in jurisdictions where the clinical trial has obtained approval from health authorities. Part 1 data will be presented to the United States (U.S.) Food and Drug Administration (FDA) to seek an Investigational New Drug (IND) amendment to progress Part 2 in the U.S. Summary results ProstACT Global Part 1 dosed 36 patients, allocated across 3 cohorts: Cohort 1 (11 patients): TLX591-Tx + enzalutamide. Cohort 2 (11 patients): TLX591-Tx + abiraterone. Cohort 3 (14 patients): TLX591-Tx followed by docetaxel. Safety and tolerability An acceptable safety profile was observed across combination cohorts and tolerability of TLX591-Tx was consistent with prior studies. All 36 patients received both doses of TLX591-Tx per protocol, no new safety signals were observed. Almost all treatment-emergent non-hematologic events were Grade 1 or Grade 2. The most prevalent were fatigue (53%), nausea (28%) and dry mouth (25%). Hematologic events were transient and manageable. Grade 3 thrombocytopenia (14%) and neutropenia (22%), and Grade 4 thrombocytopenia (31%) and neutropenia (25%) events were in line with the profile expected for this class of therapy and extent of disease. Dosimetry and biodistribution Radiation exposure to key organs was well below established safety limits. Limited dose to salivary glands and kidneys. Lesion dosimetry demonstrated uptake across tumor sites and across all cohorts. Pharmacokinetics demonstrated sustained activity at 15 days, corroborated by imaging which demonstrated prolonged tumor retention. No evidence of drug-drug interactions impacting TLX591-Tx targeting, distribution or clearance. ProstACT Global (ClinicalTrials.gov ID: NCT06520345) is an international, multicenter trial in two parts: Part 1, safety and dosimetry lead-in with 36 patients (complete); and Part 2, 2:1 randomized global expansion with an overall target enrollment of approximately 490 patients. Eligible patients must have confirmed progressive mCRPC assessed with a 68Ga-PSMA-11 PET imaging agent (such as Illuccix®, kit for the preparation of gallium-68 (68Ga) gozetotide injection, or Gozellix®, kit for the preparation of gallium-68 (68Ga) gozetotide injection) following prior treatment with one ARPI. The antibody approach demonstrates different targeting and pharmacology to that observed in other PSMA-targeted small molecule radioligand therapies (RLT). In contrast to these therapies, collective long-term follow-up of patients administered with TLX591-Tx has not observed significant acute or delayed kidney toxicity, as the agent is primarily cleared through the liver, a comparatively radioresistant organ, instead of the kidneys. Due to its large molecular weight, TLX591-Tx also demonstrates minimal salivary and lacrimal gland uptake, reducing dry mouth and dry eyes, common adverse effects of existing PSMA-targeted RLTs. Aankondiging • Feb 20
Telix Pharmaceuticals Limited Provides Earnings Guidance for the Fiscal Year 2026 Telix Pharmaceuticals Limited provided earnings guidance for the fiscal year 2026. For the year, the company expects group revenue guidance of USD 950 million to USD 970 million. Guidance reflects revenue from product sales in jurisdictions with a marketing authorization, and a full year of revenue contribution from RLS. Aankondiging • Feb 18
Telix Pharmaceuticals Limited Submits European Marketing Authorization Application for TLX101-Px for Brain Cancer Imaging Telix Pharmaceuticals Limited announced that it has submitted a marketing authorization application (MAA) in Europe for TLX101-Px (O-(2[2[18F]fluoroethyl)-L-tyrosine, 18F-FET), its glioma (brain cancer) imaging candidate. Telix has been preparing the European and U.S. regulatory packages for TLX101- Px concurrently, bringing forward the European submission to meet an agreed filing date while aligning with aspects of the U.S. Food and Drug Administration (FDA) package to support the additional application. The submission covers major European markets1. Telix is seeking to expand patient access to advanced brain imaging through a broad clinical label, reflective of current clinical practice guidelines. Submission of the U.S. New Drug Application (NDA) will follow. In Europe, positron emission tomography (PET) imaging of glioma with 18F-FET (FET-PET) is currently performed under physician-supervised use through hospital-based production at a limited number of sites. However, there is currently no generally available commercial product in Europe that ensures consistent quality and access for glioma imaging, an acute and immediate need. Telix aims to expand patient access to advanced imaging that can distinguish progressive or recurrent glioma from treatment-related changes in both adults and children, with potential for additional future indications. TLX101-Px is also being developed as a patient selection and response assessment tool for Telix's glioblastoma therapy candidate TLX101-Tx (iodofalan 131I), which has been granted orphan drug designation in Europe and the U.S. and is the subject of the Phase 3 IPAX-BrIGHT trial in patients with recurrent glioblastoma, launching in multiple European countries. Aankondiging • Feb 04
Telix Pharmaceuticals Limited to Report Fiscal Year 2025 Results on Feb 19, 2026 Telix Pharmaceuticals Limited announced that they will report fiscal year 2025 results on Feb 19, 2026 Aankondiging • Jan 20
Telix Pharmaceuticals Limited Announces Chinese National Medical Products Administration Accepts New Drug Application for Illuccix for Prostate Cancer Imaging Telix Pharmaceuticals Limited announced that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has accepted the filing of a New Drug Application (NDA) for TLX591-Px (Illuccix®?, Kit for the preparation of 68Ga-PSMA-11), Telix's lead prostate cancer imaging agent. The NDA was submitted with Telix's strategic partner for the Greater China region, Grand Pharmaceutical Group Limited (00512.HK, Grand Pharma). seeking a broad label that reflects clinical utility at multiple stages of prostate cancer care, the submission includes data from the Illuccix China Pivotal Phase 3 Registration study1, which reported positive top-line results in December 20252. The Illuccix China study met its primary endpoint, with an overall patient-level positive predictive value (PPV) of 94.8% for the detection of tumors in patients with biochemical recurrence (BCR) of prostate cancer with TLX591-Px2,3. This confirmed that the clinical experience of TLX591-Px PSMA-PET4 imaging in Chinese patients is comparable to studies in non- Chinese patients. The high PPV was demonstrated even in patients with very low PSA 5 values, and across differing metastatic locations. More than two-thirds (67.2%) of patients experienced a change in their treatment plan as a consequence of TLX591-P x PSMA-PET imaging compared with the initial plan at baseline3, demonstrating a major impact on clinical decision-making in Chinese patients. Aankondiging • Jan 17
Telix Pharmaceuticals Limited Doses First U.S. Patient in BiPASS: Phase 3 Prostate Cancer Diagnosis Study Telix Pharmaceuticals Limited on January 16, 2026 announced that the first patient in the United States (U.S.) has been dosed in BiPASS (Biopsy of the Prostate Avoidance Stratification Study), a Phase 3 trial to evaluate the use of Telix’s commercial PSMA-PET imaging agents, Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) and Gozellix (kit for the preparation of gallium Ga 68 gozetotide injection) in the initial prostate cancer diagnosis setting. The dose was administered under the supervision of Dr. Brian Mazzarella at Urology Austin and supplied by RLS Radiopharmacies. BiPASS is the first study designed to gain marketing authorization for 68Ga-PSMA-PET imaging in the pre-biopsy setting. The prospective, open-label Phase 3 trial will enroll 250 patients across sites in the U.S. and Australia. The study aims to determine whether combining MRI with Illuccix/Gozellix 68Ga-PSMA-11 PET can improve diagnostic accuracy and reduce unnecessary biopsies compared to current standard practice. Men with elevated PSA often proceed from an inconclusive MRI to template prostate biopsy. This procedure is stressful and unpleasant, can lead to complications and frequently proves to be of no benefit to the patient. The objective of BiPASS is to demonstrate improved lesion detection and patient stratification by integrating non-invasive molecular Illuccix/Gozellix 68Ga-PSMA-11 PET imaging early in the diagnostic pathway, to enable biopsy de-escalation or, alternatively, greater biopsy precision when administered. If the BiPASS study achieves its primary objectives, it could lead to a reduction in unnecessary biopsies, improved patient experience, and a significant expansion of access to precision imaging for patients with suspected prostate cancer, potentially increasing the use of 68Ga-PSMA-11 PET in a large new patient population. Aankondiging • Dec 18
Telix Pharmaceuticals Limited Provides Update on global Phase 3 ProstACT study of Prostate Cancer Therapy TLX591 Telix Pharmaceuticals Limited provided an update to confirm the current status of the ProstACT Global Phase 3 study of its lead prostate cancer therapy candidate TLX591 (lutetium (177Lu) rosopatamab tetraxetan) in patients with metastatic castration resistant prostate cancer (mCRPC). This announcement is provided in response to inaccurate information in market circulation. ProstACT Global is the first Phase 3 trial to combine a PSMA1-targeted radio antibody-drug conjugate (rADC) therapy administered together with Standard of Care (SOC; abiraterone, enzalutamide or docetaxel) versus SOC alone. Telix confirms that it has completed patient enrolment into Part 1 of the study, a safety and dosimetry lead-in, in accordance with the study protocol. Preparation is now underway to complete data lock and read-out. This includes data from each of the three cohorts in Part 1, including the docetaxel cohort which was the final cohort to complete enrolment. As previously disclosed2, data from Part 1 will be presented to the United States (U.S) Food and Drug Administration (FDA) to ascertain eligibility for U.S. patients to participate in the Part 2 (randomized treatment expansion) portion of the study. Preliminary results from Part 1 of the study will be publicly disclosed at the time of readout and engagement with the FDA. In accordance with the study protocol, an Independent Data Monitoring Committee (IDMC) has reviewed the available data in Part 1 of the study and, per the IDMC charter, has recommended that the study proceed to Part 2. Accordingly, Telix has advanced the study into Part 2, in jurisdictions where it has obtained approval from health authorities. Part 2 has been initiated on the basis that Part 1 indicates no unexpected safety or clinical characteristics that differ from prior experience. Part 2 of ProstACT Global has dosed its first patients, and is approved and open for enrolment in Australia, New Zealand and Canada. The study has also received regulatory approval to commence in China, Singapore, Türkiye, the United Kingdom, South Korea and Japan3. As part of the further global expansion of the trial, Telix intends to file a clinical trial application (CTA) with the European Medicines Agency (EMA) to enable expansion into EU sites. Aankondiging • Nov 20
Telix Pharmaceuticals Limited Announces Results from the Zircon-X Study Telix Pharmaceuticals Limited announced results from the ZIRCON-X study which finds that almost half of all patients imaged with TLX250-CDx (Zircaix®?, 89 Zr-DFO-girentuximab) PET/CT2 would have undergone a change in clinical management, when compared with baseline standard of care (SOC) imaging. The data will be presented at the 26th Annual Meeting of the Society of Urologic Oncology (SUO) being held in Phoenix, AZ, December 2 - 5, 2025. ZIRCON-X was a non-interventional, prospective, post-hoc study sponsored by Telix - using imaging data from Telix's parent pivotal Phase 3 ZIRCON study3 - that assessed the impact of TLX250-CDx imaging on clinical decision-making versus SOC contrast-enhanced diagnostic imaging in 294 patients with indeterminate renal masses (IRMs)4. The study found that 143 patients (48.6%) would have undergone a Change in clinical management if imaged with TLX250 -CDx, and over 20% of these patients (31 out of 143) could have potentially avoided invasive biopsy. The primary objective was to assess whether TLX250-CDx PET/CT has an impact on clinical decision-making versusOC conventional contrast-enhanced diagnostic imaging In patients presenting with an IRM. Four multi-disciplinary teams (MDTs) at four separate institutions evaluated ZIRCON data from 294 evaluable patients in two steps: Step 1: MDTs issued a patient management decision based on SOC conventional imaging and clinical/laboratory data (excluding histology). Step 2: After a minimum 4-week interval, MDTs reassessed the same cases, this time informed by the TLX250-CDxPET/CT imaging results and the same clinical/laboratory data. Clinical management for each individual patient was determined by MDT consensus. Data will support Telix's planned marketing authorization application for TLX250-CDx in Europe. Telix is headquartered in Melbourne, Australia, with international operations in the United States, United Kingdom, 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. Aankondiging • Nov 11
Rosen Law Firm Files Securities Class Action Lawsuit Against Telix Pharmaceuticals Ltd Rosen Law Firm announced it has filed a class action lawsuit on behalf of purchasers of the securities of Telix Pharmaceuticals Ltd. between February 21, 2025 and August 28, 2025, both dates inclusive (the “Class Period”). The lawsuit seeks to recover damages for Telix investors under the federal securities laws. According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) Defendants materially overstated the progress Telix had made with regard to prostate cancer therapeutic candidates; (2) Defendants materials overstated the quality of Telix’s supply chain and partners; and (3) as a result, defendants statements about Telix’s business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages. Aankondiging • Oct 23
Telix Pharmaceuticals Limited Doses First Patient in SOLACE Trial for Metastatic Bone Pain Telix Pharmaceuticals Limited announced that it has dosed the first patient in a Phase 1 clinical trial of TLX090 (153Samarium (Sm)-DOTMP), a therapeutic radiopharmaceutical candidate for treating pain associated with bone metastasis. TLX090 is designed to deliver targeted radiation to bone tumors while minimizing damage to surrounding healthy tissues. SOLACE (Samarium Optimized for Long-lasting Analgesia in Cancerous End-stage bone pain) is an open-label Phase 1 clinical trial enrolling up to 33 patients with advanced cancer that has metastasized to the bone skeleton1. The trial is designed to evaluate the pharmacokinetics, dosimetry, safety, and pain palliation of TLX090, a next-generation radiopharmaceutical candidate optimized for improved safety profile and efficacy. Data from SOLACE aims to establish clinical comparability to legacy 153Sm treatments, which in turn is expected to support a streamlined registration pathway as an analgesic, paving the way for a much-needed, non-opioid solution for patients living with bone pain in the late stages of advanced cancer. Existing treatments often fall short--whether through limited effectiveness, incomplete pain relief, or burdensome side effects. TLX090 offers the potential for a better tolerated and more effective approach to pain management, with the goal of meaningfully improving patients' quality of life. Even with the introduction of new treatments, including targeted radiation therapy, most metastatic cancer patients will eventually progress and need treatment for bone pain. TLX090 has the potential to bridge cancer treatment and quality-of-life care by offering a single-dose, systemic option for these patients addressing the significant unmet need across multiple cancer types. This presents a major clinical opportunity, aligned with commitment to prostate cancer, and a potential commercial entry point into the therapeutic market. Aankondiging • Oct 14
Telix Pharmaceuticals Limited Upgrades Revenue Guidance for the Fiscal Year 2025 Telix Pharmaceuticals Limited upgraded earnings guidance for the fiscal year 2025. For the year, the company increases revenue guidance to $800 million to $820 million compared to previous Fiscal Year 2025 revenue guidance: $770 million to $800 million. Aankondiging • Sep 23
Telix Pharmaceuticals Limited Announces United States Centers for Medicare & Medicaid Services Grants Transitional Pass-Through Payment Status for Gozellix Telix Pharmaceuticals Limited announced that the United States (U.S.) Centers for Medicare & Medicaid Services (CMS) has granted Transitional Pass-Through (TPT) payment status for Gozellix (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix's next- generation PSMA-PET1 imaging agent for prostate cancer. This designation enables separate reimbursement for Gozellix under the Hospital Outpatient Prospective Payment System (HOPPS), effective 1 October 2025, and marks a significant milestone in Telix's U.S. commercial strategy. Gozellix has already been assigned a permanent Healthcare Common Procedure Coding System (HCPCS) Level II code A9616 to be recognized by CMS and commercial health insurers, effective 1 October 20252. Additionally, patients are not subject to the 20% patient coinsurance under TPT. After radiolabelling with 68Ga, Gozellix 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 biochemical recurrence (BCR) based on elevated serum prostate- specific antigen (PSA) level3. Gozellix is a novel imaging agent offering a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based products, helping to overcome many of the logistical barriers that have historically limited access to PSMA-PET imaging 4. Its innovative formulation enables scalable production, with preparation possible via gallium generators (50mCi and 100mCi) or cyclotron-based methods. This flexibility has the potential to significantly improve efficiency, scheduling flexibility, and throughput for scanning clinics 5. Cyclotron production of Gozellix is supported by the GE FASTlabTM6 solid and liquid target production system and Telix's ARTMS QUANTM Irradiation System (QIS), enabling large-scale production across both commercial networks and academic centers. Aankondiging • Sep 10
Telix Pharmaceuticals Limited Doses First Patient in Phase 3 BiPASS Trial: PSMA-PET Imaging for Prostate Cancer Diagnosis Telix Pharmaceuticals Limited announced it has dosed the first patient in a Phase 3 clinical trial aimed at expanding the indications for Illuccix®? and Gozellix®? (kits for the preparation of gallium-68 (68Ga) gozetotide injection) to include prostate cancer diagnosis. BiPASS™? (Biopsy of the Prostate Avoidance Stratification Study1) is the first registration-enabling study to evaluate whether the combination of MRI2 and PSMA-PET3 imaging can improve sensitivity, specificity, and positive and negative predictive values in diagnosing prostate cancer. The aim of the study is to demonstrate that some patients can be effectively stratified to either avoid a biopsy altogether or undergo a single PSMA-PET guided biopsy instead. Telix plans to enrol 204 patients in Australia and the United States (U.S.) for the single arm, multicenter, prospective, open label, longitudinal Phase 3 study. The first BiPASS™? patient was dosed under the supervision of Principal Investigator Professor Tony Costello AM at the Australian Prostate Centre (APC), and imaged by Professor Rodney Hicks AM, at the Melbourne Theranostic Innovation Centre (MTIC). The first patient biopsy was performed by BiPASS™? Investigator and Clinical Director at APC, Mr. Phil Dundee. Aankondiging • Jul 30
Telix Pharmaceuticals Limited to Report First Half, 2025 Results on Aug 21, 2025 Telix Pharmaceuticals Limited announced that they will report first half, 2025 results on Aug 21, 2025 Aankondiging • Jul 22
Telix Pharmaceuticals Limited Confirms Earnings Guidance for the Fiscal Year 2025 Telix Pharmaceuticals Limited confirmed earnings guidance for the fiscal year 2025. For the year, the company confirms revenue guidance of $770 million to $800 million. Guidance reflects revenue from Illuccix sales in jurisdictions with a marketing authorization, and 11 months of revenue contribution from RLS. Telix confirms research and development (R&D) expenditure guidance, expecting a year-over-year increased investment range for fiscal year 2025 of 20% to 25% compared to fiscal year 2024. Aankondiging • Jul 10
Telix Pharmaceuticals Limited Receives Permanent HCPCS Code for Gozellix from U.S. Centers for Medicare & Medicaid Services Telix Pharmaceuticals Limited announces that its next-generation PSMA PET imaging agent, Gozellix® (kit for the preparation of gallium-68 (Ga) gozetotide injection), has been granted a permanent Healthcare Common Procedure Coding System (HCPCS) code by the U.S. Centers for Medicare & Medicaid Services (CMS).Effective from 1 October 2025, CMS and commercial health insurers will recognise the HCPCS Level II code A9616 assigned for reimbursement of Gozellix. The assignment of the code is a significant milestone supporting provider billing and reimbursement for Gozellix, and a further step toward receiving Transitional Pass-Through (TPT) payment status. After radiolabelling with Ga, Gozellix 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 biochemical recurrence (BCR) based on elevated serum prostate-specific antigen (PSA) level. With its extended shelf-life and flexible production options, Gozellix overcomes many of the logistical barriers that have historically limited access to PSMA-PET imaging. Telix believes receiving a HCPCS code will support clinical adoption of Gozellix and expanded access to PSMA PET imaging. Aankondiging • Jun 24
Telix Pharmaceuticals Limited Approves in U.S. for Patient Selection for Pre-Taxane RLT Telix Pharmaceuticals Limited announced that the United States (U.S.) Food and Drug Administration (FDA) has approved a label expansion for Illuccix® (kit for the preparation of gallium Ga-68 gozetotide, for injection) to include patient selection for radioligand therapy (RLT) in the pre-taxane setting. The update applies to Illuccix's third indication, for selection of patients who are indicated for PSMA1-directed therapy as described in the Prescribing Information of the therapeutic products. The label expansion follows the FDA's approval of an expanded label for Pluvicto®2 (lutetium Lu177 vipivotide tetraxetan) for use in metastatic castration-resistant prostate cancer (mCRPC) patients after treatment with androgen receptor pathway inhibitor (ARPI) therapy and before chemotherapy3. With RLT now approved for use earlier in the patient journey, the clinical utilization of Illuccix® is expected to increase by at least 20,000 scans annually. With this update, patients can now benefit from the high diagnostic accuracy of Illuccix to identify those most likely to respond to PSMA-targeted therapy, even earlier in their treatment journey. Illuccix, after radiolabeling with Ga 68, is for positron emission tomography (PET) of prostate-specificmembrane antigen (PSMA) positive lesions in men with prostate cancer: With suspected metastasis who are candidates for initial definitive therapy; With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level; For selection of patients who is indicated for PSMA-directed therapy. The performance of Illuccix for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Radiation R 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. En 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. The safety of gallium Ga 68 gozetucle was evaluated in 960 patients in the PSMA-PreRP and PSMA-BCR studies, each receiving one dose of gallium Ga 68 goZetotide. The average injected activity was 188.7 +- 40.7 MBq. Aankondiging • Jun 20
Telix Precision Medicine Announces AlFluor Radiochemistry Platform Telix Pharmaceuticals Limited announced it has launched a novel PET1 radiochemistry solution based on 18F-aluminium fluoride (AlF), named AlFluor™?. The AlFluor™? platform technology enables flexible radiolabeling of PSMA2 with either AlF or gallium-68 (68Ga). It also has the potential to be used with ligands targeting NETs3 and FAP4, as well as other novel imaging agents under development by Telix and its strategic partners. This flexibility allows a complementary product with the same targeting agent to be labeled with either isotope, catering to clinical setting or physician preference. As part of AlFluor's development, Telix has signed a strategic agreement with University Hospital Ghent and Ghent University for a novel [18F]AlF-PSMA-11 targeting agent. The agreement includes a comprehensive chemistry, manufacturing and controls (CMC) package suitable for the preparation of a Drug Master File (DMF), and provides exclusive access to [18F]AlF -PSMA-11 clinical safety and efficacy data, including a Phase 3 trial in 96 prostate cancer patients, where PSMA-11 (gozetotide) was labeled interchangeably with 18F and 68Ga. The trial demonstrated diagnostic performance comparable to commercial 68Ga-labeled PSMA-11 agents such as Illuccix®? and Gozellix®?, both known to deliver high specificity (90%) for metastatic detection at initial staging5. AlF-PSMA-11 has also demonstrated favorable biodistribution, high tumor-to- background ratios, and low off-target uptake in multiple studies. Aankondiging • Jun 13
Telix Pharmaceuticals Limited Announces Prostate Cancer PSMA-PET Imaging Agent Approved in Greece Telix Pharmaceuticals Limited announced that its prostate cancer PET imaging agent Illuccix®? (kit for the preparation of gallium-68 gozetotide injection) has been granted marketing authorization by the Greek EOF for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer - a broad clinical label. This approval enhances the options available to healthcare providers across Greece for PSMA-PET imaging using a clinically-validated, gallium-based radiopharmaceutical. Illuccix, after radiolabelling with gallium-68, is indicated in Greece for the detection of prostate-specific membrane antigen ("PSMA)-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings: Primary staging of patients with high-risk PCa prior to primary curative therapy. Suspected recurrent PCa in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy. Prostate cancer is the most common cancer for men in Greece with over 7,000 new cases diagnosed annually, and a significantly higher incidence in men than either bowel cancer (4,346 new cases) or lung cancer (6,357 new cases). Prostate cancer is the third most common cause of cancer death in men in Greece, with just over 1,900 men dying from their disease in 2022. Aankondiging • Jun 11
Telix Launches New Prostate Cancer Imaging Agent, Gozellix, in U.S Telix Pharmaceuticals Limited announced that its next-generation PSMA-PET imaging agent for prostate cancer, Gozellix® (kit for the preparation of gallium-68 (Ga) gozetotide injection), is now commercially available nationally in the United States (U.S.).Gozellix is available through Telix’s comprehensive network of distribution partners, Cardinal Health Inc., PharmaLogic Holdings Corp., Jubilant Radiopharma, and RLS Radiopharmacies. After radiolabelling with Ga, Gozellix 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 biochemical recurrence (BCR) based on elevated serum prostate-specific antigen (PSA) level. Gozellix builds on proven diagnostic excellence to provide early and accurate detection of metastases at initial staging, with 90% specificity. This clinical performance enables detection of millimetre-scale micrometastases, at PSA levels as low as 0.02 ng/mL. These valuable insights enable physicians to make more informed clinical decisions. In recent years, PSMA-PET imaging has become established as the standard of care for staging and identifying biochemical recurrence of prostate cancer. However, only a relatively small fraction of the 3.4 million men living with prostate cancer in the U.S. have benefited from this technology, in part due to access and availability challenges. Telix has applied for reimbursement for Gozellix, for Medicare-eligible patients in the hospital outpatient setting. Gozellix’s enhanced formulation, with an extended “hot” shelf-life of up to six hours, offers a greater level of patient access and convenience through an extended transportation distance and clinical administration window. Telix estimates that up to 20% of PET cameras in the U.S. are beyond the reach of currently available PSMA-PET imaging agents due to distribution efficiency constraints. By overcoming this limitation, Gozellix can improve access for prostate cancer patients, regardless of where they live, with greater scheduling flexibility for clinicians and their patients. Gozellix can be either centrally produced with a cyclotron or locally prepared with a gallium generator with up to 500mCi of activity, enabling greater production flexibility and on-demand capacity. Cyclotron-based production of Gozellix is supported by the ARTMS QUANTM Irradiation System® (QIS®), the market-leading cyclotron solid target irradiation system. Aankondiging • Jun 04
Telix Pharmaceuticals Limited's Illuccix® PSMA-PET Imaging Agent Approves in Portugal Telix Pharmaceuticals Limited announced that its prostate cancer PET imaging agent, Illuccix®? (kit for the preparation of gallium-68 gozetotide injection), has been granted marketing authorization in Portugal by INFARMED for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. This approval enhances the options available to healthcare providers across Portugal for PSMA-PET imaging using a clinically validated gallium-based radiopharmaceutical. Illuccix, after radiolabelling with gallium-68, is indicated in Portugal for the detection of prostate-specific membrane antigen ("PSMA)-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings: Primary staging of patients with high-risk PCa prior to primary curative therapy. Suspected recurrent PCa in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy. Prostate cancer is the most common cancer in men in Portugal, with just over 7,500 new cases diagnosed annually, and a significantly higher incidence in men than either bowel (6,092 new cases) or lung cancer (4,253 new cases). Prostate cancer is also the third most common cause of cancer death in men, with just over 2,080 menying from their disease in Portugal in 2022. Aankondiging • May 05
Telix Pharmaceuticals Limited's Illuccix PSMA-PET Imaging Agent Approved in the Czech Republic Telix Pharmaceuticals Limited announced that its prostate cancer PET imaging agent, Illuccix®? (kit for the preparation of gallium-68 gozetotide injection), has been granted marketing authorization in the Czech Republic by the SUKL for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. This approval provides healthcare providers in the Czech Republic with broader access to PSMA-PET imaging, using a clinically validated gallium-based radiopharmaceutical. Illuccix, after radiolabelling with gallium-68, is indicated in the Czech Republic for the detection of prostate-specific membrane antigen ("PSMA)-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings: Primary staging of patients with high-risk PCa prior to primary curative therapy. Prostate cancer is the most common cancer in men in the Czech Republic, with close to 8,000 new cases diagnosed annually, and a significantly higher incidence in men than either bowel (4,376 new cases) or lung cancer (3,709 new cases). Prostate cancer is also the third most common cause of cancer death in men, with over 1,600 menying from their disease in the Czech Republic in 2022. Aankondiging • Apr 30
Telix Pharmaceuticals Limited Announces Illuccix Prostate Cancer PSMA-PET Imaging Agent Approve in Finland Telix Pharmaceuticals Limited announced that its prostate cancer PET imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection) has been granted marketing authorization by Fimea for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. This approval enables healthcare providers in Finland to offer PSMA-PET imaging using a clinically validated gallium-based radiopharmaceutical. Illuccix, after radiolabelling with gallium-68, is indicated in Finland for the detection of prostate-specific membrane antigen ("PSMA)-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings: Primary staging of patients with high-risk PCa prior to primary curative therapy. Prostate cancer is the most common cancer for men in Finland with over 5,900 new cases diagnosed annually, and a significantly higher incidence in men than either bowel cancer (2,123 new cases) or lung cancer (1,828 new cases). Prostate cancer is the second most common cause of cancer death in men in Finland, with just over 930 men dying from their disease in 2022. Aankondiging • Apr 22
Telix Pharmaceuticals Limited Reaffirms Earnings Guidance for the Fiscal Year 2025 Telix Pharmaceuticals Limited reaffirmed earnings guidance for the fiscal year 2025. For the year, the company reaffirms guidance of $770 million to $800 million. Revenue guidance is expected to be updated at the appropriate time, following and subject to reimbursement for Gozellix® in the United States (U.S.) and Illuccix® in ex-U.S. markets. Guidance reflects revenue from Illuccix® sales in jurisdictions with a marketing authorization, and 11 months of revenue from RLS. Aankondiging • Apr 18
Telix Pharmaceuticals Limited Announces Preliminary Results from the Phase 2 IPAX-Linz Study of Tlx101 Telix Pharmaceuticals Limited announced preliminary results from the Phase 2 IPAX-Linz study of TLX101(I-iodofalan) in recurrent high-grade glioma (brain cancer), substantiating the patient benefit seen in the IPAX-1 study. IPAX-Linz is a single-arm Phase 2 investigator-initiated trial (IIT). The company is grateful to Dr. Pichler and his team for building on the IPAX-Linz study in a more advanced and complex study cohort that is also representative of a real-world patient population. Preliminary results from IPAX-Linz will be presented by Dr. Pichler at the Nuclear Medicine and Neurooncology (NMN) Symposium taking place in Vienna, Austria from 9 10 May 2025. Telix continues to investigate TLX101 in front-line and recurrent settings. IPAX-2, a Phase 1/2 study in front-line glioblastoma in combination with standard of care and using TLX101-CDx as a companion diagnostic, continues to recruit patients. Telix has submitted for ethics approval a registration-enabling study of TLX101 in recurrent glioblastoma. Subject to approval this will enable patient enrolment to commence at Australian sites in second quarter 2025, ahead of international expansion. Following the successful pre-IND meeting with the U.S. Food and Drug Administration (FDA) in fourth quarter 2024, the Company is also on track to submit an IND application in first quarter 2025, with the goal of commencing the study at U.S. sites in second quarter 2025. Aankondiging • Apr 16
Telix Pharmaceuticals Limited Announces Preliminary Results from the Phase 2 IPAX-Linz Study of TLX101 Telix Pharmaceuticals Limited announced preliminary results from the Phase 2 IPAX-Linz study of TLX101 (131I-iodofalan1) in recurrent high-grade glioma (brain cancer), substantiating the patient benefit seen in the IPAX-1 study2. IPAX-Linz is a single-arm Phase 2 investigator-initiated trial (IIT). IPAX-Linz evaluates the safety, tolerability and preliminary efficacy of TLX101 therapy, in combination with external beam radiation therapy (EBRT). IPAX-Linz continues to investigate TLX101 in front-line and recurrent settings. IPAX-Linz, a Phase 1/2 study in front-line glioblastoma in combination with standard of care and using TLX101-CDx as a companion diagnostic, continues to recruit patients. Telix has submitted for ethics approval a registration-enabling study of TLX101 in recurrent glioblastoma. Subject to approval this will enable patient enrolment to commence at Australian sites in second quarter 2025, ahead of international expansion. Following the successful pre-IND9 meeting with the U.S. Food and Drug Administration (FDA) in fourth quarter 2024, the Company is also on track to submit an IND application in first quarter 2025, with the goal of commencing the study at U.S. sites in H2 2025. Aankondiging • Apr 15
Telix Pharmaceuticals Limited Prostate Cancer PSMA-PET Imaging Agent Approves in Sweden Telix Pharmaceuticals Limited announces that its prostate cancer PETimaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection) has been granted marketing authorization by the Swedish MPAfor the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. This approval enables healthcare providers in Sweden to offer PSMA-PET imaging using a clinically validated gallium-based radiopharmaceutical.Illuccix, after radiolabelling with gallium-68, is indicated in Sweden for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings: Primary staging of patients with high-risk PCa prior to primary curative therapy. Suspected recurrent PCa in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy. Identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated.PSMA-PET imaging represents a significant advancement in prostate cancer management, largely replacing conventional imaging methods (bone scan, CTscan) as the standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines highlight the superior accuracy of PSMA-PET for the staging of primary disease and evaluation of BCR/biochemical persistence (BCP). Illuccix® PSMA-PET will help fulfil a critical unmet need by facilitating access to timely and effective diagnosis and patient selection for treatment with PSMA-targeted therapy.Illuccix's broad approval is supported by robust clinical data, including the largest Ga-68-based PSMA data set from the VISION trial. Aankondiging • Apr 07
Telix Pharmaceuticals Limited Appoints Paul Schaffer as Chief Technology Officer, Effective April 6, 2025 Telix Pharmaceuticals Limited announced that is has appointed Dr. Paul Schaffer to the newly created role of Chief Technology Officer, effective April 6, 2025. Dr. Schaffer has been CTO at ARTMS Inc. (acquired by Telix in 2024) for the past seven years, as well as Director, Life Science at TRIUMF, Canada's particle accelerator research centre, since 2012. Based in Vancouver, Canada, Dr. Schaffer is widely recognized for his role in the buildout and transformation of the TRIUMF Life Sciences program, which included design and construction of a major multi-cyclotron radiochemistry facility and the development of the ARTMS QUANTM Irradiation System for large-scale isotope production, which was commercialized and later acquired by Telix. As Telix CTO, Dr. Schaffer will be responsible for harnessing the power of technology to advance Telix's capabilities in radiopharmaceutical research, development, and clinical applications. Dr. Schaffer will cover areas including chemistry, physics, artificial intelligence, dosimetry, and data analytics, complementing the work of Telix's Chief Scientist, Dr. Michael Wheatcroft, and his team in driving cutting-edge research and development. Aankondiging • Apr 04
Telix Pharmaceuticals Limited Announces Appointment of Anne Whitaker as A Non-Executive Director Based in the United States, Effective 7 April 2025 Telix Pharmaceuticals Limited announced the appointment of Anne Whitaker as a Non-Executive Director (NED) based in the United States, effective 7 April 2025. Ms. Whitaker is a seasoned healthcare leader and advisor with over 30 years' global corporate experience spanning large pharmaceutical, biotech and speciality pharmaceutical companies, including clinical research and manufacturing organizations. She has held Board positions on a range of Nasdaq-listed clinical and commercial stage life sciences companies. Ms. Whitaker is currently serving as a NED at Icon PLC and is Chair at QurAlis Corporation. Ms. Whitaker is an accomplished C-suite leader, most recently as Chair and CEO of Aerami Therapeutics Holdings Inc. During her executive career she has held senior leadership roles at GlaxoSmithKline (GSK), Sanofi and Bausch Health. Ms. Whitaker holds a Bachelor of Science in
Chemistry and Business from the University of North Alabama. Aankondiging • Apr 02
ARTMS Drug Master File for Gallium Production Technology Referenced with Telix's Gozellix Telix ARTMS Inc. announced that the drug master file (DMF)1 for gallium-68 production using its QUANTM Irradiation System®? (QIS®?) cyclotron technology has been referenced for the first time with a United States (U.S.) Food and Drug Administration (FDA) approved product, with Gozellix (kit for the preparation of gallium-68 (68Ga) gozetotide injection). This approval will enable radiopharmacies and hospitals using ARTMS' QIS®? cyclotron technology and associated targets to produce multi-Curies of 68Ga for use with Gozellix. The expanded distribution radius and increased dose production capacity, compared to existing gallium-based PET tracers, will facilitate broader and more appropriate access. Aankondiging • Mar 18
Telix Pharmaceuticals Limited Announces That the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria) Approves Illuccix®? (68Ga) Prostate Cancer Imaging Agent Telix Pharmaceuticals Limited announced that the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or ‘ANVISA’) has approved Illuccix® (kit for the preparation of gallium-68 (Ga) gozetotide injection) the Company’s lead prostate cancer imaging agent. Illuccix® is the first and only PSMA-PET prostate cancer imaging agent to receive full regulatory approval in Brazil.Illuccix®, after radiolabeling with Ga, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer: With suspected metastasis who are candidates for definitive initial therapy treatment, and With suspected recurrence based on an elevated specific antigen (PSA) level in the serum. The marketing authorization is granted to Telix’s partner R2PHARMA, Brazil’s leading cold kit manufacturer, nuclear pharmacy and cyclotron network, and a subsidiary of GSH Corp. Participações S.A. (Grupo GSH). Telix has provided Grupo GSH with an exclusive license to manufacture, distribute and market Illuccix® in Brazil.PSMA-PET is a diagnostic technology demonstrated to detect advanced prostate cancer. ANVISA becomes the latest regulatory body worldwide to approve Illuccix®, which is already commercially available in Australia, Canada, New Zealand and the United States, and has recently been approved in the United Kingdom and in multiple countries within the European Economic Area (EEA). Aankondiging • Feb 25
Telix Pharmaceuticals Limited Announces That the Biogenix Molecular Research Center Is Recruiting and Dosing Patients in the ProstACT Global Phase 3 Trial of TLX591 for Patients with Advanced Prostate Cancer Telix Pharmaceuticals Limited announced that the Biogenix Molecular Research Center in Miami, FL, is recruiting and dosing patients in the ProstACT Global Phase 3 trial of TLX591 for patients with advanced prostate cancer, as part of a wider United States (U.S.) roll-out. ProstACT Global is trialling a promising new treatment option for prostate cancer, which is the most commonly diagnosed cancer and the second leading cause of cancer-related death for U.S. men. This month, Biogenix Molecular Research Center successfully administered two doses of TLX591, 14 days apart, to a local Miami-based patient, and continues to recruit eligible patients in the Miami area. The trial – sponsored by Telix – will investigate and confirm the benefits and risks associated with TLX591 as first-line and second-line therapy in metastatic castration resistant prostate cancer (mCRPC) in combination with standard of care. The innovative trial design is differentiated by a patient-friendly dosing regimen (two doses, 14 days apart) and integrates with real-world standards of care (abiraterone, enzalutamide, or docetaxel chemotherapy), reflective of Telix’s continued innovation in prostate cancer care and commitment to patient outcomes. ProstACT Global is the first trial to combine the synergistic effects of prostate-specific membrane antigen- (PSMA)- targeted radio antibody-drug conjugate (rADC) therapy in combination with androgen receptor pathway inhibition (ARPI), and docetaxel sensitization. This approach differs from commercially available PSMA-targeted monotherapy and previous or active studies being conducted with small molecule peptide carrier radioligand therapies (RLTs). Aankondiging • Feb 24
Telix Pharmaceuticals Limited's Illuccix PSMA-PET Imaging Agent Approved in Norway Telix Pharmaceuticals Limited announced that its prostate cancer PET imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection) has been granted marketing authorization by NOMA for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. This approval enables healthcare providers in Norway to offer PSMA-PET imaging using a clinically-validated gallium-based radiopharmaceutical. Illuccix, after radiolabelling with gallium-68, is indicated in Norway for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings: Primary staging of patients with high-risk PCa prior to primary curative therapy. Suspected recurrent PCa in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy. Identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated. PSMA-PET imaging represents a significant advancement in prostate cancer management, providing clinicians with more information than conventional imaging methods (bone scan, CT scan) thereby offering a new standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines highlight the superior accuracy of PSMA-PET for the staging of primary disease and evaluation of BCR/biochemical persistence (BCP). Illuccix® PSMA-PET will help fulfil a critical unmet need by facilitating access to timely and effective diagnosis and patient selection for treatment with PSMA-targeted therapy. Illuccix's broad approval is supported by robust clinical data, including the largest Ga-68-based PSMA data set from the VISION trial. Illuccix® has the potential to improve access to PSMA-PET in Norway by enabling hospitals and clinics to prepare the product on-site. In particular, in settings where there is a reliance on fluorine-18 (18F) tracers, the availability of Illuccix®, a GMP-quality prostate cancer imaging product, will help to avoid delivery delays and other logistical barriers, improving access. With its broad indication and ready-to-use formulation, Illuccix® is designed to support healthcare providers in delivering efficient and reliable imaging. The approval comes as demand for PSMA-PET continues to grow across Europe, reinforcing the need for solutions that fit within existing hospital workflows. Aankondiging • Feb 20
Telix Pharmaceuticals Limited, Annual General Meeting, May 21, 2025 Telix Pharmaceuticals Limited, Annual General Meeting, May 21, 2025. Aankondiging • Feb 13
Telix Pharmaceuticals Limited Announces the United Kingdom Medicines and Healthcare Products Regulatory Agency Approves the Marketing Authorization Application for Its Prostate Cancer PET Imaging Agent Illuccix® Telix Pharmaceuticals Limited announced that the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the Marketing Authorization Application (MAA) for its prostate cancer PET imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection). Illuccix is indicated in the UK for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, using PET. PSMA-PET imaging represents a major advancement in prostate cancer management, largely replacing conventional imaging methods (bone scan, CT3 scan) as the standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines highlight the superior accuracy of PSMA-PET for the staging of primary disease and evaluation of BCR/biochemical persistence (BCP). Illuccix will be made available in the UK through Telix's exclusive distribution partner, Xiel Limited, a specialist distributor of nuclear medicine, radiotherapy and diagnostic radiology technologies across the UK and Ireland. Aankondiging • Feb 12
Telix Pharmaceuticals Limited Announces Danish Medicines Agency Approves its Prostate Cancer PET Imaging Agent Illuccix® (Kit for the Preparation of Gallium-68 Gozetotide Injection) Telix Pharmaceuticals Limited announced that its prostate cancer PET imaging agent Illuccix®? (kit for the preparation of gallium-68 gozetotide injection) has been approved by the Danish Medicines Agency (Laegemiddelstyrelsen). Illuccix, after radiolabelling with gallium-68, is indicated in Denmark for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings: Primary staging of patients with high-risk PCa prior to primary curative therapy. Suspected recurrent PCa in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy. Illuccix will be made available in Denmark through Telix's distribution partner for the Nordic region, WIIK Pharma ApS (WIIk Pharma), a specialist supplier and distributor of nuclear medicine products and services. Aankondiging • Jan 31
Telix Pharmaceuticals Limited (ASX:TLX) completed the acquisition of Next-Generation Therapeutic Assets of ImaginAb, Inc. Telix Pharmaceuticals Limited (ASX:TLX) entered into an asset purchase agreement to acquire Next-Generation Therapeutic Assets of ImaginAb, Inc. for $45 million on January 13, 2025. The upfront consideration value was $45 million, of which $10 million has been paid to ImaginAb in cash, with $31 million paid in equity through the issue of 2.05 million fully paid ordinary Telix shares at $24.37 per share. A deferred payment of up to $4 million will be paid to ImaginAb in equity at the conclusion of a 15-month indemnity period. The assets include a pipeline of next-generation therapeutic candidates, proprietary novel biologics technology platform, and a protein engineering and discovery research facility to enhance existing innovation capabilities. This transaction adds a pipeline of early-stage drug candidates against high-value targets including DLL31 and integrin avß6 2, as well as several other novel targets in discovery stage. The consideration for $45 million includes a cash component of $10 million in cash and equity component of $31 million in equity at closing. The deal also includes a deferred payment of up to $4 million in equity at the conclusion of a 15-month indemnity period. The transaction is subject to regulatory approvals and other third-party consents. Jefferies LLC and Stifel, Nicolaus & Company, Incorporated acted as financial advisors to ImaginAb.
Telix Pharmaceuticals Limited (ASX:TLX) completed the acquisition of Next-Generation Therapeutic Assets of ImaginAb, Inc. on January 30, 2025. Aankondiging • Jan 29
Telix Pharmaceuticals Limited (ASX:TLX) completed the acquisition of RLS (USA) Inc. from Rls Group Ltd. Telix Pharmaceuticals Limited (ASX:TLX) agreed to acquire RLS (USA) Inc. from Rls Group Ltd for $250 million on September 23, 2024. A cash consideration of $230 million will be paid by Telix Pharmaceuticals Limited. Telix Pharmaceuticals Limited will pay an earnout/contingent payment of $20 million cash. As part of consideration, $250 million is paid towards common equity of RLS (USA) Inc. The transaction will be financed through equity investment of $230 million. RLS will continue to service its existing customers and operate as an independent business unit under Telix Manufacturing Solutions.
The transaction is subject to approval by regulatory board / committee, approval of offer by target shareholders and third party approval needed. The acquisition is expected to close early in the first quarter of 2025.
Telix Pharmaceuticals Limited (ASX:TLX) completed the acquisition of RLS (USA) Inc. from Rls Group Ltd on January 28, 2025. RLS will continue to operate under the same name and as a standalone business within Telix Manufacturing Solutions (TMS), which includes other key Telix brands with multi-vendor and third-party relationships such as ARTMS, IsoTherapeutics and Optimal Tracers. Kirkland & Ellis LLP acted as legal advisor to Rls Group. Aankondiging • Jan 17
Telix Pharmaceuticals Limited Receives Positive Decision on the Marketing Authorization Application for Its Prostate Cancer PET Imaging Agent Illuccix Telix Pharmaceuticals Limited announced that it has received a positive decision on the Marketing Authorization Application (MAA) for its prostate cancer PET imaging agent Illuccix (kit for the preparation of gallium-68 gozetotide injection), which was submitted in Europe via a decentralized procedure (DCP). This significant milestone follows the issuance of the Final Assessment Report from the German Competent Authority BfArM2 as Reference Member State (RMS). Through the DCP, the RMS and all 18 European Economic Area (EEA) Concerned Member States (CMS)3 agree that Illuccix should receive marketing authorization. The DCP regulatory process will now transition into an administrative national phase to implement authorizations to facilitate commercial launch in each country4. This clinically important prostate cancer imaging modality is currently recommended in international clinical practice guidelines including European Association of Urology (EAU) and European Society for Medical Oncology (ESMO). PSMA-PET imaging5 represents a major advancement in prostate cancer management, largely replacing conventional imaging methods (bone scan, CT6 scan) as the standard of care after initial diagnosis and biochemical recurrence (BCR). European guidelines highlight the superior accuracy of PSMA-PET for the staging of primary disease7 and evaluation of BCR/biochemical persistence (BCP). Telix’s lead 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 U.S. Food and Drug Administration (FDA), by the Australian Therapeutic Goods Administration (TGA) 10, and by Health Canada11. Aankondiging • Jan 13
Telix Pharmaceuticals Limited to Report Q4, 2024 Results on Feb 20, 2025 Telix Pharmaceuticals Limited announced that they will report Q4, 2024 results on Feb 20, 2025 Aankondiging • Jan 01
Telix Pharmaceuticals Limited Submits its Biologics License Application to the United States Food and Drug Administration for TLX250-CDx (Zircaix, Zr- girentuximab) Kidney Cancer Imaging Telix Pharmaceuticals Limited announced that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX250-CDx (Zircaix, Zr- girentuximab) kidney cancer imaging. TLX250-CDx is an investigational PET drug product for the non-invasive diagnosis and characterisation of clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer. If approved, TLX250-CDx will be the first and only targeted PET agent specifically for kidney cancer to be commercially available in the U.S., further building on Telix's successful urology imaging franchise. The FDA is expected to advise the PDUFA goal date following the 60-day administrative review of the application. Telix is headquartered in Melbourne, Australia, with international operations in the United States, 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. The FDA requested additional data demonstrating adequate sterility assurance during dispensing of TLX250-CDx in the radiopharmacy production environment. Positron emission tomography. Telix's lead imaging product, gallium-68 (Ga) gozetotide injection (also known as Ga PSMA-11 and marketed under the brand name Illuccix), has been approved by the U.S. Food and Drug Administration (FDA), by the Australian Therapeutic Goods Administration (TGA), and by Health Canada. No other Telix product has received a marketing authorization in any jurisdiction. Aankondiging • Dec 19
Telix Pharmaceuticals Limited Completes the Installation of Two New Cyclotron at Telix Manufacturing Solutions in Brussels South, Belgium Telix Pharmaceuticals Limited announced that it has completed the installation of two new cyclotrons at Telix Manufacturing Solutions (TMS) in Brussels South, Belgium, facilitating the production of radioisotopes and patient doses on-site from 2025. The installation of cyclotrons from GE Healthcare (Nasdaq: GEHC) and IBA (Ion Beam Applications S.A., EURONEXT), along with proprietary solid targets, establishes TMS Brussels South as a major nuclear medicine production facility, which will serve as the Company's primary manufacturing site for the Europe Middle East and Africa (EMEA) region and beyond. One cyclotron will be dedicated to clinical and commercial supply, and the other to research and development (R&D), meaning TMS Brussels South will serve as a vital hub for manufacturing scale-up and production of next generation radiopharmaceuticals, including diagnostics and both alpha- and beta therapeutics.Telix was granted an updated radiation licence in 2022 by the Belgian Federal Agency for Nuclear Control (FANC) for a broad range of commercially important medical isotopes. Both cyclotrons have multi-isotope capacity and will have ARTMS' QUANTM Irradiation System (QIS) installed to support high efficiency, large-scale and cost-effective production. This includes clinical and commercial supply in Europe of gallium-68 (Ga), zirconium-89 (Zr), fluorine-18 (F) and copper-64 (Cu), along with the capacity to produce R&D quantities of actinium-225 (Ac) for targeted alpha therapy. Commissioning of the cyclotrons is scheduled to begin in early First Quarter 2025, with first commercial good manufacturing practice (GMP) production anticipated in H2 2025, subject to requisite audits and accreditation. Aankondiging • Nov 28
Telix Pharmaceuticals Limited and Grand Pharmaceutical Group Limited Announces First Patient Dosed in Phase III ZIRCON-CP Trial of TLX250-CDx for Kidney Cancer Imaging in Chinese Patients Telix Pharmaceuticals Limited and Grand Pharmaceutical Group Limited announced that a first patient has been dosed in the Phase III ZIRCON-CP trial of TLX250-CDx positron emission tomography (PET) imaging of clear cell renal cell carcinoma (ccRCC). The patient was successfully dosed and imaged at Beijing Cancer Hospital in Beijing, China. ZIRCON-CP is a multi-centre Phase III registration trial in China intended to bridge to Telix's global Phase III ZIRCON trial, which met all co-primary and secondary endpoints, including showing 86% sensitivity and 87% specific, and a mean positive-predictive value (PPV) of 93% for ccRCC. The company believe this demonstrated the ability of TLX250-CD x to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing ccRCC. Confidence intervals exceeded expectations in all three readers, showing evidence of high accuracy and consistency of interpretation. As part of Telix's commitment to access to medicine, the Company continues to run an expanded access program (EAP) in the U.S., named patient programs (NPPs) in Europe, and a special access scheme (SAS) in Australia to allow continued access to TLX250-CDx outside of a clinical trial to patients for whom there are no comparable or satisfactory alternate options. Aankondiging • Oct 24
Telix Pharmaceuticals Limited Announces FDA Accepts New Drug Application and Grants Priority Review for TLX101-CDx Brain Cancer Imaging Agent Telix Pharmaceuticals Limited announced that the United States Food and Drug Administration has accepted the New Drug Application for TLX101-CDx (Pixclara), an agent for the imaging of glioma. The application has been granted priority review and designated a PDUFA2 goal date of 26 April 2025, paving the way for a U.S. commercial launch in 20253. Pixclara (18F-floretyrosine or 18F-FET) is a PET agent for the characterisation of progressive or recurrent glioma from treatment related changes in both adult and pediatric patients. FET PET is already included in international clinical practice guidelines for the imaging of gliomas, however there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain
cancer imaging commercially available in the U.S. Given its potential to address significant unmet medical need, Pixclara has been designated as an orphan drug and granted fast track designation by the FDA. There is a critical unmet need to improve the diagnosis and management of gliomas, which are the most common primary brain tumours of the central nervous system, particularly in the post-treatment setting. Conventional MRI7 imaging techniques have several limitations, including a lack of biological specificity, dependency on blood-brain barrier disruption, and an inherent inability to differentiate between tumour progression or treatment-related causes. This can yield inconclusive results and delay time-sensitive treatment decisions8.
With low survival rates and the need to make rapid decisions, precision imaging is paramount. Subject to regulatory approval, Pixclara has the potential to address this need, enabling patients in the U.S. to receive greater clarity in their diagnosis and treatment decision making. Telix is also reviewing the potential use of Pixclara as a "companion" diagnostic agent for TLX101-Tx, the investigational neuro-oncology drug currently in development, which targets the same amino acid transporter mechanism with therapeutic targeted radiation. Aankondiging • Oct 08
Australian TGA Approves Additional Indication for Telix's Illuccix® to Include Patient Selection for PSMA-Targeted Therapy Telix Pharmaceuticals Limited announced that the Australian Therapeutic Goods Administration (TGA) has approved the use of Illuccix® (kit for the preparation of 68Ga-PSMA-11 injection) to select patients for PSMA-targeted radionuclide therapy. Illuccix remains the only PSMA-PET agent approved in Australia, manufactured to GMP standards, and listed on the Medicare Benefits Schedule (MBS) for imaging patients with prostate cancer. This label expansion means that it is now approved to select patients with metastatic prostate cancer for treatment with the only approved PSMA-targeted radionuclide therapy (Lu 177 vipivotide tetraxetan, or Pluvicto). To qualify for PSMA-targeted therapy, patients should be identified by PSMA imaging. The latest approval expands the clinical utility for Illuccix, which has been approved in Australia since November 2021 for the initial staging of intermediate to high-risk patients with prostate cancer and the re-staging of patients with recurrent prostate cancer. Aankondiging • Oct 03
Telix Pharmaceuticals Initiates Phase II Trial for Tlx250-Cdx in Recurrent Clear Cell Renal Cell Carcinoma Telix Pharmaceuticals Limited announced that the first patient has been dosed in a Phase II trial exploring the clinical utility of Telix’s first-in-class investigational PET1 agent, TLX250-CDx (89Zr-girentuximab) in recurrent clear cell renal cell carcinoma (ccRCC) after surgery. CA-NINE’2 – led by Professor Brian Shuch at University of California, Los Angeles (UCLA) – is a Phase II prospective, single-centre trial comparing the diagnostic performance of TLX250-CDx PET/CT3 to conventional imaging (contrast-enhanced CT alone) in 91 patients with intermediate-to-high risk ccRCC post-surgery. The investigator-initiated trial is designed to identify ccRCC where it has recurred, including metastatic disease, and is one of multiple trials either underway or planned, which may inform future label expansion for TLX250-CDx. TLX250-CDx (Zircaix®489Zr-girentuximab) is an investigational PET agent that is under development to characterize indeterminate renal masses as ccRCC or non-ccRCC in a non-invasive manner. Telix’s pivotal Phase III ZIRCON trial (ClinicalTrials.gov ID: NCT03849118) evaluating TLX250-CDx in 300 patients, of which 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% positive-predictive value for ccRCC across three independent readers5. We believe this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing ccRCC. Confidence intervals exceeded expectations in all three readers, showing evidence of high accuracy and consistency of interpretation. As part of Telix’s commitment to access to medicine, the Company continues to run an expanded access program (EAP) in the U.S., named patient programs (NPPs) in Europe, and a special access scheme (SAS) in Australia to allow continued access to TLX250-CDx outside of a clinical trial to patients for whom there are no comparable or satisfactory alternate options. Aankondiging • Sep 23
Telix Pharmaceuticals Limited (ASX:TLX) agreed to acquire RLS (USA) Inc. from Rls Group Ltd for $250 million. Telix Pharmaceuticals Limited (ASX:TLX) agreed to acquire RLS (USA) Inc. from Rls Group Ltd for $250 million on September 23, 2024. A cash consideration of $230 million will be paid by Telix Pharmaceuticals Limited. Telix Pharmaceuticals Limited will pay an earnout/contingent payment of $20 million cash. As part of consideration, $250 million is paid towards common equity of RLS (USA) Inc. The transaction will be financed through equity investment of $230 million. RLS will continue to service its existing customers and operate as an independent business unit under Telix Manufacturing Solutions.
The transaction is subject to approval by regulatory board / committee, approval of offer by target shareholders and third party approval needed. The acquisition is expected to close early in the first quarter of 2025. Aankondiging • Aug 28
Telix Submits NDA for TLX101-Cdx (Pixclara®) Brain Cancer Imaging Agent Telix Pharmaceuticals Limited announced it has submitted a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-CDx, (Pixclara®, 18F-floretyrosine or 18F-FET), an investigational PET agent for the characterisation of progressive or recurrent glioma (brain cancer) from treatment related changes in both adult and pediatric patients. Given the potential to address significant unmet medical need, Pixclara® has been granted Orphan Drug and Fast Track designation by the FDA, which facilitates expedited review and closer consultation with the agency during the review process. FET PET (Pixclara®) is already included in international clinical practice guidelines for the imaging of gliomas, however there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.S. There is a critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting. With low survival rates and the need to make rapid decisions, precision imaging is paramount. Subject to regulatory approval, Pixclara® has the potential to address this need, enabling patients to receive greater clarity in their diagnosis and treatment decision making. Pixclara®1 is also being developed as the "companion" theranostic imaging agent for TLX101, Telix's investigational neuro-oncology drug candidate, which targets the same amino acid transporter mechanism with therapeutic targeted radiation. Reported Earnings • Aug 23
Second quarter 2024 earnings released: EPS: AU$0.035 (vs AU$0.018 loss in 2Q 2023) Second quarter 2024 results: EPS: AU$0.035 (up from AU$0.018 loss in 2Q 2023). Revenue: AU$189.0m (up 58% from 2Q 2023). Net income: AU$11.7m (up AU$17.5m from 2Q 2023). Profit margin: 6.2% (up from net loss in 2Q 2023). Revenue is forecast to grow 19% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Aankondiging • Jul 30
Telix Pharmaceuticals Limited Announces Expanded Access Program Opens in the U.S. for Tlx101-Cdx, Telix’s Investigational Glioma (Brain Cancer) Imaging Agent Telix Pharmaceuticals Limited announced the opening of an expanded access program in the United States for TLX101-CDx (Pixclara, 18F-floretyrosine or 18F-FET) an investigational positron emission tomography agent for imaging progressive or recurrent glioma, following U.S. Food and Drug Administration agreement to proceed. Amino acid PET is included in U.S. and European clinical practice guidelines for the imaging of gliomas, however there is no FDA-approved targeted amino acid PET agent for brain cancer imaging currently available in the U.S. Telix’s goal is to make this product commercially available in the U.S., significantly increasing patient access to this important imaging agent for both adult and paediatric patients. The Company expects to file its New Drug Application (NDA) for TLX101-CDx with the FDA during Third Quarter 2024. Under its EAPs – sometimes also called ‘compassionate use’ – the FDA works with companies to allow access to investigational products, outside of a clinical trial, to patients with serious or life-threatening illnesses, for whom there are no comparable or satisfactory alternate options. Board Change • Jul 22
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. Independent Non-Executive Director Jann Skinner was the last director to join the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Aankondiging • Apr 12
Telix Pharmaceuticals Limited (ASX:TLX) completed the acquisition of ARTMS, INC. Telix Pharmaceuticals Limited (ASX:TLX) signed an agreement to acquire ARTMS, INC. for approximately $84 million on March 4, 2024. The purchase price comprises: $42.5 million upfront consideration which is payable in the form of 5,674,636 Telix ordinary shares to be issued at closing; $15.0 million upfront consideration payable in cash at closing; $24.5 million in contingent future earn out payments, payable in cash following achievement of certain clinical or commercial milestones; and cash earn-outs representing low single to low double-digit percentage of net sales of ARTMS products or Telix products prepared using ARTMS products for defined periods depending on the product location where the sale occurs. All earn-outs which have not otherwise expired will terminate on the 10 year anniversary following completion of the ARTMS acquisition. The cash upfront consideration is subject to customary working capital, debt and transaction expense adjustments. Telix will issue ordinary shares to the stockholders of ARTMS at closing within its Listing Rule 7.1 placement capacity, in part-consideration for the acquisition. The shares will be subject to escrow restrictions. Closing of the transaction is subject to customary conditions, including regulatory approvals.
Telix Pharmaceuticals Limited (ASX:TLX) completed the acquisition of ARTMS, INC. April 11, 2024. Aankondiging • Apr 11
Telix Pharmaceuticals Limited (ASX:TLX) completed the acquisition of IsoTherapeutics Group, LLC for $8.1 million. Telix Pharmaceuticals Limited (ASX:TLX) entered into an agreement to acquire IsoTherapeutics Group, LLC for $13.6 million on February 26, 2024. As for consideration, purchase price comprises, $8 million upfront, which is payable at closing in the form of $2 million and $6 million in ordinary shares, equating to approximately 0.82 million ordinary shares, $5 million performance-related milestone payments, payable in cash, that are subject to meeting milestone conditions within twelve months of closing, and a two-year revenue share based on actual revenue earned from existing customers of IsoTherapeutics total estimated cash payments $0.6 million. Transaction is subject to Closing of the customary conditions, including regulatory approvals.
Telix Pharmaceuticals Limited (ASX:TLX) completed the acquisition of IsoTherapeutics Group, LLC for $13.7 million on April 9, 2024. Consideration will be paid as $8.1 million, of which $6 million will be paid through 0.717587 shares and remaining will be paid in cash as $2.1 million. Aankondiging • Mar 05
Telix Pharmaceuticals Limited (ASX:TLX) signed an agreement to acquire ARTMS, INC. for approximately $84 million. Telix Pharmaceuticals Limited (ASX:TLX) signed an agreement to acquire ARTMS, INC. for approximately $84 million on March 4, 2024. The purchase price comprises: $42.5 million upfront consideration which is payable in the form of 5,674,636 Telix ordinary shares to be issued at closing; $15.0 million upfront consideration payable in cash at closing; $24.5 million in contingent future earn out payments, payable in cash following achievement of certain clinical or commercial milestones; and cash earn-outs representing low single to low double-digit percentage of net sales of ARTMS products or Telix products prepared using ARTMS products for defined periods depending on the product location where the sale occurs. All earn-outs which have not otherwise expired will terminate on the 10 year anniversary following completion of the ARTMS acquisition. The cash upfront consideration is subject to customary working capital, debt and transaction expense adjustments. Telix will issue ordinary shares to the stockholders of ARTMS at closing within its Listing Rule 7.1 placement capacity, in part-consideration for the acquisition. The shares will be subject to escrow restrictions. Closing of the transaction is subject to customary conditions, including regulatory approvals. 
