FDA Approves Telix’s Brain Cancer Imaging Drug Pixclara

Melbourne (Australia) and Indianapolis, IN (United States) | September 14, 2026

- Pixclara® is the first FDA-approved FET-PET imaging drug for glioma (brain cancer).

- Approval addresses a significant unmet need, helping physicians to differentiate recurrent or progressive glioma from treatment-related change in adults and pediatric patients.

- FET-PET imaging is recommended in international clinical practice guidelines, including NCCN Guidelines®.

- Pixclara expands Telix’s industry-leading Precision Medicine business and reinforces the Company’s leadership in diagnostics and targeted radiopharmaceutical therapies (together, “theranostics”).

Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Pixclara® (floretyrosine F 18 or 18F-FET), an amino acid positron emission tomography (PET) drug for imaging gliomas (brain cancer).

Pixclara is a radioactive diagnostic drug indicated for use with positron emission tomography (PET) to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and pediatric patients 1 month of age and older.

PET imaging with floretyrosine F 18 (FET-PET) is recommended in international clinical practice guidelines for the imaging of gliomas, including NCCN Guidelines®[1], but until now there has not been an FDA-approved product available in the U.S.

Gliomas are the most common form of central nervous system (CNS) cancer, accounting for approximately 30% of all brain and CNS tumors and 80% of all malignant brain tumors[2]. In the U.S., approximately 24,000 new glioma cases are diagnosed each year[3], representing a significant unmet addressable need.

Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, said, “FDA approval of Pixclara will enable broad access in the U.S. to FET-PET imaging, which is already recognized in international clinical practice guidelines. As the first FDA-approved PET imaging drug for glioma, Pixclara will provide physicians in the U.S. with more certainty in their diagnoses and greater confidence in their treatment planning for patients.”

Kelly Sitkin, President and CEO, American Brain Tumor Association, said, “The approval of Pixclara will advance glioma care by enabling more precise monitoring, complementing the role of MRI. We welcome the FDA’s decision, which provides a pathway to access this technology in the U.S. and helps address a critical unmet need in brain cancer diagnostics.”

Patrick Wen, MD, E. Antonio Chiocca, MD, PhD, Family Endowed Chair in Neuro-Oncology at Mass General Brigham Cancer Institute, said, “Having an FDA-approved FET-PET product with high diagnostic accuracy will make a significant, positive difference to the management of patients with gliomas. This is a very positive step forward for brain cancer imaging and treatment planning.”

About Pixclara (floretyrosine F 18)

Pixclara® is an intravenous positron emission tomography (PET) imaging drug for the differentiation of recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and pediatric patients 1 month of age and older. It comprises a small molecule targeting compound labeled with a diagnostic radioisotope, fluorine-18. After administration into the bloodstream, Pixclara targets membrane transport proteins known as L-type amino acid transporters 1 and 2 (LAT1 and LAT2). Once bound, energy emissions from the radioisotope can be detected by a PET scanner. Pixclara (TLX101-Px) is also the subject of a Phase 3 registrational study for potential indication expansion for the diagnosis of brain metastases[4].

Pixclara is the only FDA-approved radiopharmaceutical imaging drug for glioma (brain cancer).

INDICATIONS AND USAGE

PIXCLARA is indicated for use with positron emission tomography (PET) to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and pediatric patients 1 month of age and older.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Risk for Misinterpretation

Image misinterpretation may occur with PIXCLARA PET. A negative image does not rule out the presence of recurrent or progressive glioma and a positive image does not confirm the presence of recurrent or progressive glioma. Equivocal findings may occur with PIXCLARA PET, including low-level or atypical uptake patterns, which may result in false positive or false negative interpretations.

Interpret PIXCLARA PET findings with caution and correlate results with available clinical evaluations, such as histopathology, cross-sectional imaging, and/or clinical history to support appropriate clinical decision-making.

Radiation Risks

PIXCLARA contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

ADVERSE REACTIONS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of PIXCLARA was evaluated in 382 patients with gliomas. Among these 382 patients, 371 adult patients received at least one intravenous dose of PIXCLARA at a mean activity of 204 ± 18 MBq (5.5 ± 0.47 mCi). The remaining 11 pediatric patients received at least one intravenous dose of PIXCLARA at a mean activity of 155 ± 53.5 MBq (4.2 ± 1.4 mCi).

The mean age of the patients was 57 years (range: 5 years to 86 years). Sex was 59% male, 37% female, and 3% unreported. Distribution by race was 26% White, 6% Asian, 1% Black or African American, and 67% other or unreported. Distribution by ethnicity was 3% Hispanic/Latino, 96% non-Hispanic/Latino, and 1% unknown or unreported.

Adverse reactions that occurred in ≥0.5% of patients receiving PIXCLARA were headache (0.5%).

Adverse reactions that occurred in 0.5% of patients were nausea, injection site reaction, fatigue, and malaise.

Adverse Reactions in Pediatric Patients

Overall, the safety profile observed in pediatric patients from the clinical study was consistent with the safety profile in adult patients.

Please note that this information is not comprehensive.

Please see the Full Prescribing Information at https://telixpharma.com/wp-content/uploads/2026/09/USPI_PIXCLARA_Sep2026.pdf

You are encouraged to report suspected adverse reactions of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix Pharmaceuticals (US) by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com.

[1] Galldiks et al. Lancet Oncol. 2025 (Joint guidelines from the European Association of Nuclear Medicine (EANM), European Association of Neuro-Oncology (EANO), Society of Nuclear Medicine and Molecular Imaging (SNMMI), Response Assessment in Neuro-Oncology (RANO), The European Society for Pediatric Oncology and The Response Assessment in Pediatric Neuro-Oncology for the characterization of recurrence in glioma patients); National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers V3.2026.

[2] Goodenberger et al. Cancer Genet. 2012.

[3] CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2018-2022. Neuro-Oncology. 2025.

[4] Investigational New Drug (IND) application successfully cleared, with Study May Proceed notification received from FDA. Telix ASX disclosure August 20, 2026.

“Let’s go, let’s get them”

During Prostate Cancer Awareness Month, Telix is speaking with the advocates and patients on the front line of fighting prostate cancer.

Michael Ramos served for 16 years as the elected District Attorney of San Bernardino County, California. In 2017, a year before he planned to retire, he was diagnosed with prostate cancer. We spoke with him about his diagnosis, the scan that changed the course of his care, and why he now brings a prosecutor’s energy to patient advocacy.

The diagnosis

A shock diagnosis

Michael Ramos spent his entire career as a public servant. He started as a probation officer, went to law school, and became a trial lawyer in the district attorney’s office, where he tried 125 jury trials driven by a passion for crime victims. In 2002, he was elected District Attorney of San Bernardino County, California, a position he held for 16 years, working with governors and legislators along the way.

He was also, by any measure, healthy.

“I used to do triathlons,” he says. “I worked out every day. I had a very stressful job. People would go to lunch, I’d go to the gym.”

Then in 2017, a year before he was going to retire, Michael was diagnosed with prostate cancer.

“It took me back. I remember going to my car and just sitting in my driver’s seat. The first person I called was my wife, and I said, here’s the news. And along with that, it was, okay, what now?”

Michael’s shock is shared by many of the men who receive the same news each year. Around one in eight men will be diagnosed with prostate cancer in their lifetime, and in 2026 an estimated 333,830 new cases will be diagnosed in the United States alone.1 It remains the second-leading cause of cancer death in American men, behind only lung cancer.1

Prostate cancer in the United States, 2026 estimates.

The decision

What now? Building a support team

Michael’s answer to that question came from two directions: his medical team and his family. Together with his urologist, his wife, his son and his daughter, he sat down and worked through the options, from surgery to remove the prostate to radiation and brachytherapy.

“The combination of both sitting down professionally with a medical doctor and then with the people that really care and love you, that’s how we made the decision,” he says. “It made it easier having that kind of a team.”

Michael began treatment, including around two years of hormone therapy. Then his PSA started climbing again.

PSA stands for prostate-specific antigen, a protein made by cells in the prostate gland. Small amounts of PSA can enter the bloodstream, where it can be measured with a simple blood test. Higher levels can be an early sign of a prostate problem, including cancer.

For men treated for prostate cancer, a rising PSA is a familiar and feared turn. Between 27% and 53% of patients who undergo surgery or radiation therapy will go on to experience biochemical recurrence.2 The critical question then becomes where the cancer is, and conventional imaging such as CT and bone scans can struggle to locate small sites of disease.3

The scan

Finding every cell

Years earlier, Michael had read a newspaper article about a doctor at Loma Linda University Medical Center who was, in his words, doing fantastic stuff with nuclear medicine. He kept the article. When his PSA began rising, he tracked down its subject, Dr. Frankis Almaguel, Director of Molecular Imaging and Therapeutics at Loma Linda University Cancer Center. They met at his lab two days later.

“He told me, we want to do a PSMA-PET scan so we can actually see where the cancer cells are,” Michael says.

Prostate-specific membrane antigen (PSMA) is a protein found at high levels on the surface of most prostate cancer cells, making it a powerful target for molecular imaging.4 By pairing a radioactive tracer with a molecule that binds to PSMA, positron emission tomography (PET) can show physicians where prostate cancer cells are in the body. In a landmark clinical trial, PSMA-PET imaging was significantly more accurate than conventional imaging (CT and bone scanning) in men with high-risk prostate cancer.3

Michael’s scan revealed two areas of disease. Rather than leaving him to wait for a report, his doctor stayed to walk him through the images on screen.

“The beautiful thing is he stayed to explain to me the results,” Michael says. “There were two places where it kind of lit up. I remember feeling like, okay, let’s go, let’s get them.”

For a career trial lawyer, the appeal of seeing the disease was empowering.

“The result was like a game plan. It was a great piece of, I’ll use my analogy again, evidence. Direct evidence, not circumstantial. Here it is. Here’s the plan.”

Armed with the scan, Michael’s care team, spanning nuclear medicine, radiation oncology, medical oncology and urology, mapped out targeted treatment for the sites of disease. After his first treatment two years ago, his PSA fell sharply.

Asked whether he would have reached the same plan, and the same confidence, without the scan, his answer is blunt.

“No. I’m not sure where I’d be. I’m sure they would have tried other treatments, but this was a game changer, because we could come up with a specific plan.”

At Telix, PSMA-PET imaging sits at the core of our prostate cancer portfolio, developed to help physicians see the location and extent of disease and support more informed treatment decisions at critical points in the patient journey. We are also advancing investigational PSMA-targeted radiopharmaceutical therapies, designed to deliver cancer-killing radiation directly to diseased cells while limiting the impact on surrounding healthy tissue. This theranostic approach, pairing precision diagnostics with targeted therapy directed at the same molecular target, is central to our work in prostate cancer and beyond.

Advocacy

Putting cancer in prison

Michael retired from the district attorney’s office, but not from public service. Having met many people living with cancer, he has found a new focus for the energy he once brought to the courtroom.

“My passion has changed,” he says. “I still care about crime victims, of course, but now, as a cancer survivor, it is my priority to do what I can as an advocate to help those people that have had this diagnosis of cancer.”

He follows the field closely, listening to doctors at conferences and watching the pace of progress. Even now, he talks about the disease the way a prosecutor talks about a case.

“Like I used to put criminals in prison for hurting victims, we’re going to put cancer in prison,” he says. “The technology is amazing. With companies like this and doctors like Dr. Almaguel, we will be able to not just keep us alive for another year or two.”

When asked what he would say to other men facing a prostate cancer diagnosis today, his answer is immediate.

“Don’t lose hope. Technology has changed so much since I was diagnosed. As I listen to doctors at various conferences, the future is bright. You’re going to live a long life. You will live a long life.” Michael Ramos

References

- American Cancer Society. Key Statistics for Prostate Cancer. cancer.org. Cancer Facts & Figures 2026.

- Artibani W, et al. Management of Biochemical Recurrence after Primary Curative Treatment for Prostate Cancer: A Review. Urol Int. 2018;100(3):251–262.

- Hofman MS, et al. Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multicentre study. Lancet. 2020;395(10231):1208–1216.

- Silver DA, et al. Prostate-specific membrane antigen expression in normal and malignant human tissues. Clin Cancer Res. 1997;3(1):81–85.

This article is for educational and disease-awareness purposes and does not constitute medical advice or product promotion.

Telix and ITM Join Forces to Create a Radiopharmaceutical Powerhouse

Melbourne (Australia), Indianapolis, IN (United States) and Munich (Germany) | September 21, 2026

- Transformational merger reflects Telix’s long-term growth strategy as a vertically integrated radiopharmaceutical company with enhanced capabilities across development, isotope production and global manufacturing, underpinned by commercial excellence and the industry’s most extensive therapeutic pipeline.

- ITM is the world’s leading supplier of therapeutic radioisotopes, with broad capabilities spanning lutetium-177 (177Lu), actinium-225 (225Ac) and terbium-161 (161Tb) production.

- ITM is the only producer of globally scaled commercial-grade 177Lu and serves as a key supplier for both commercially available and future therapeutic radiopharmaceuticals.

- ITM’s commercial-scale and profitable isotope production business significantly contributes to cash generation while deepening Telix’s supply chain for isotopes required for its therapeutics pipeline.

- ITM’s complementary pipeline includes ITM-11 (177Lu-edotreotide), a novel, therapeutic candidate for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs), which has successfully completed Phase 3 development, potentially accelerating entry into a validated commercial market for targeted radionuclide therapy (TRT).

- Upfront consideration of US$1.65 billion on a cash-free/debt-free basis. After adjustments, ITM Shareholders are expected to be paid approximately US$1.25 billion in Telix Shares at US$11.841 per share, released as Nasdaq ADRs after the respective escrow periods.

- Additional contingent consideration of up to US$700 million upon achievement of regulatory approvals and commercial sales milestones for ITM-11.

- The transaction is subject to Telix Shareholder approval and other customary closing conditions.

Investor conference call to be held today at 9:30 a.m. AEST Monday September 21, 2026. (7:30 p.m. EDT Sunday September 20, 2026 / 1:30 a.m. CEST Monday September 21, 2026).

Register at the following link: https://s1.c-conf.com/diamondpass/10057230-8w1zq8.html

Telix today announces it has signed a strategic agreement to lead a merger with ITM Isotope Technologies Munich SE (“ITM”), a global leader in radioisotope production and radiopharmaceutical development.

The merger will further strengthen Telix’s leadership as a vertically integrated radiopharmaceutical company with the capabilities required to develop, manufacture and deliver innovative treatments to patients globally. The combined organization will be uniquely positioned as a radiopharmaceutical industry leader, differentiated by a world-class scaled isotope manufacturing business with a validated global distribution network, a market-leading commercial precision medicine platform and the industry’s most extensive therapeutic radiopharmaceutical pipeline.

Founded in 2004, ITM is a private company with a leading commercial scale radioisotope manufacturing and global distribution network spanning over 65 countries. ITM is a key supplier of 177Lu and – with a compound annual growth rate (CAGR) of 40% from 2021 to 2025 – delivered annual revenue of US$273 million in 20252. This commercial momentum is underpinned by increasing global demand for TRT and radioisotopes for commercially approved products and assets under clinical development. The global nuclear medicine market is forecast to reach US$41 billion by 20343.

ITM’s late-stage novel pipeline is complementary to Telix and includes ITM-11 (177Lu-edotreotide), a differentiated somatostatin receptor (SSTR)-targeted treatment for GEP-NETs. ITM-11 has completed a successful Phase 3 trial (COMPETE, NCT03049189)4 and fully enrolled a second indication expansion Phase 3 study (COMPOSE, NCT04919226) with an interim analysis expected in H1 2027. If approved, ITM-11 has the potential to accelerate Telix’s entry into the commercial therapeutic market and expand its presence in neuroendocrine tumors, a commercially validated and clinically significant market for TRT.

The combined organization is expected to generate unaudited pro forma 2026 revenue and income exceeding US$1.3 billion5, based on management estimates. ITM’s radioisotope manufacturing business is profitable and generates cash flow. Continued growth from manufacturing, cost savings and further synergies and pipeline optimization are expected to support a positive EBITDA6 contribution in 20277 and onward. If approved by health regulators, the launch of ITM-11 is expected to drive further upside, with the potential to generate additional high-margin therapeutic revenue in the near term.

Telix Managing Director and Group CEO, Dr. Christian Behrenbruch, said, “This merger positions Telix at the forefront of the consolidation that is occurring as the industry matures. ITM is the leader in radioisotope production, with deep scientific expertise and a track record of value-adding innovation. We have enjoyed a close working relationship with ITM for many years and there is strong management alignment for the rationale behind this transaction. By combining our complementary strengths, we will create a company with commercial scale, world-leading supply and the most exciting theranostic drug portfolio in the sector. Importantly, this combination further expands our late-stage therapeutic pipeline with two completed Phase 3 trials and deepens radioisotope security, while bringing together the mission critical capabilities needed to deliver radiopharmaceutical treatments to patients around the world.”

ITM Chief Executive Officer, Dr. Andrew Cavey, added, “Joining two radiopharmaceutical pioneers creates a company with unmatched breadth and depth across the value chain, supported by deep expertise and talent. Our management teams have a track record of working together and a nuanced understanding of our respective commercial strengths and customer relationships. Together, we believe Telix and ITM will be uniquely positioned to capitalize on rapidly growing global demand for radiopharmaceuticals to the benefit of both Shareholders and patients.”

Deal Terms

Under the terms of the agreement and subject to Shareholder approval, Telix will acquire 100% of the shares in ITM for US$1.65 billion upfront on a cash-free/debt-free basis expected as follows:

- US$1.25 billion will be paid to the sellers in the form of 105.8 million Telix shares (priced at the 30-day trailing VWAP as of signing of US$11.841) and released to the sellers as Nasdaq-listed ADRs at the end of their respective escrow periods;

- US$302 million of net debt will be assumed by Telix at closing; and

- US$96 million of management equity rollover and transaction expenses payable by the sellers8; and in each case subject to closing adjustments.

Additional contingent consideration of up to US$700 million will become payable upon the achievement of specified regulatory approvals and sales milestones for ITM-11 as set out below:

- Up to US$250 million upon U.S. Food and Drug Administration (FDA) approval of ITM-11 across three different indications:

- US$100 million upon FDA approval for expected first indication in G1-G2 GEP-NETs no later than December 31, 2027;

- US$100 million upon FDA approval for G2-G3 GEP-NETs indication no later than December 31, 2030; and

- US$50 million upon FDA approval for Lung NETs indication no later than December 31, 2031; and

- Up to US$450 million based on ITM-11 net global sales in FY 2030 in excess of US$150 million.

All milestone consideration will be payable in cash or Shares9 at Telix’s election10. Consideration paid to ITM Shareholders at closing is subject to financial adjustments at closing, indemnity holdbacks, and escrow (lockup) restrictions on the Shares issued at closing of up to 15 months which may be waived in limited part to allow the sellers to pay their tax and transaction expense liabilities.

Upon completion of the transaction, Telix Shareholders will own approximately 76.3% and ITM Shareholders will own approximately 23.7% of Telix shares on issue. The transaction has been approved by Telix’s Board of Directors and, as of signing, Shareholders holding over 90%11 of ITM’s Shares. The transaction is expected to close by the end of FY 2026 subject to Telix Shareholder approval as required under the ASX Listing Rules, regulatory approvals, and other customary closing conditions.

Refer to the Investor Presentation lodged today with the ASX for further information on the transaction.

A Notice of Meeting will be sent to Telix Shareholders for an extraordinary general meeting expected to be held in November 2026.

- Based on the 30-day trailing VWAP on the ASX prior to signing of A$16.65, converted at an AUD/USD exchange rate of 0.71. ↩︎

- ITM audited financial statements (2025). ↩︎

- MEDraysintell Current Landscape of the Nuclear Medicine Market, 2025 edition. ↩︎

- Walter T, et al. The Lancet, July 2, 2026. ↩︎

- Refer to slide 20 of the Investor Presentation released by Telix to the ASX in conjunction with this announcement. ↩︎

- Earnings before interest, tax, depreciation and amortization. ↩︎

- Subject to the realization of targeted synergies and commercial timing assumptions. Excludes one-off implementation costs. ↩︎

- Sellers may allocate and sell some of the Telix Shares deducted from closing consideration to settle a portion of these transaction expenses. ↩︎

- Priced and settled at the 30-day trailing VWAP prior to milestone achievement and converted to Nasdaq ADRs. ↩︎

- Telix will seek Shareholder approval for the issue of Shares for the milestone payments based on Telix share price at signing. ↩︎

- Remaining ITM shareholders expected to sign Joinder Agreements to the Share Purchase Agreement prior to closing. ↩︎

Telix Granted FDA Fast Track Designation for BiPASS Pre-Biopsy Prostate Cancer Imaging

Melbourne (Australia) and Indianapolis, IN (United States) | September 30, 2026

- FDA Fast Track designation granted for Telix’s BiPASS® program, which is evaluating 68Ga-PSMA-PET imaging alongside MRI in the pre-biopsy prostate cancer setting.

- The designation recognizes the program’s potential to address an important unmet need by enabling an imaging-first approach to initial prostate cancer diagnosis.

- Fast Track facilitates more frequent engagement with the FDA and may enable expedited review of the planned NDA.

Telix today announced that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s BiPASS® program.

BiPASS (Biopsy of the Prostate Avoidance Stratification Study[1]) is evaluating gallium-68 (68Ga) PSMA-PET imaging[2] in combination with MRI[3] for the detection of prostate cancer prior to biopsy.

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need[4], potentially accelerating patient access if approved. More than three million prostate biopsies are performed globally each year[5], yet up to 75% produce a negative result[6]. Biopsy can be stressful and painful for patients and may provide no meaningful diagnostic benefit[7], highlighting the importance of improved diagnostic tools earlier in the patient journey.

Telix recently completed enrollment in the Phase 3 BiPASS study of its proprietary 68Ga-PSMA-PET agents, Illuccix® (kit for the preparation of gallium Ga68 gozetotide injection) and Gozellix® (kit for the preparation of gallium Ga68 gozetotide injection) for pre-biopsy prostate cancer diagnosis. The Company has positively engaged with the FDA on a new drug application (NDA) pathway and is planning its submission. The NDA pathway supports registration as a new product which, if approved, would broaden access to 68Ga-PSMA-PET imaging for a substantially larger patient population.

BiPASS builds on the clinical foundation established by the PRIMARY[8] and PRIMARY2[9] studies. These studies demonstrated that combining 68Ga-PSMA-PET imaging with MRI can significantly improve detection of clinically significant prostate cancer while reducing unnecessary biopsies by almost 50 percent. BiPASS is not intended to replace biopsy when it benefits the patient but rather aims to improve the diagnostic pathway by helping clinicians determine which patients would benefit from biopsy and where biopsy should be targeted.

Dr. David N. Cade, Group Chief Medical Officer at Telix, said, “Fast Track designation reflects the FDA’s recognition of the potential for BiPASS to address an important unmet need in the prostate cancer diagnostic pathway. We believe gallium-68 PSMA-PET, used alongside MRI, could help physicians make more informed decisions before biopsy, improve diagnostic confidence and potentially reduce unnecessary invasive procedures for patients. This designation supports continued close engagement with the FDA as we advance BiPASS toward an NDA submission.”

Illuccix and Gozellix are approved for PET imaging of PSMA-positive lesions in patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy, and in patients with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Illuccix is also approved for the selection of patients indicated for PSMA-directed therapy. The use of Illuccix and Gozellix in the pre-biopsy setting remains investigational and has not been approved by the FDA or any other regulatory authority.

About Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection)

Illuccix, after radiolabeling with 68Ga, is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level, and for selection of patients who are indicated for PSMA-directed therapy as described in the prescribing information of the therapeutic products.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Risk for Misinterpretation

Image interpretation errors can occur with Illuccix PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Imaging Prior to Initial Definitive or Suspected Recurrence Therapy

The performance of Illuccix for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of Illuccix for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.

Radiation Risks

Gallium Ga 68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.

ADVERSE REACTIONS

The safety of gallium Ga 68 gozetotide 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 (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of 1%.

In the VISION study, 1003 patients received one dose of gallium Ga 68 gozetotide intravenously with the amount of radioactivity 167.1 ± 23.1 MBq (4.52 ± 0.62 mCi). Adverse reactions occurring at ≥0.5% in patients with metastatic prostate cancer who received gallium Ga 68 gozetotide injection in the clinical study were fatigue (1.2%), nausea (0.8%), constipation (0.5%), and vomiting (0.5%).

Adverse reactions occurring at a rate of 0.5% in the VISION study were diarrhea, dry mouth, injection site reactions, including injection site hematoma and injection site warmth and chills.

Injection site pain has been identified during post-approval use of ILLUCCIX.

DRUG INTERACTIONS

Androgen deprivation therapy and other therapies targeting the androgen pathway

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.

Please note that this information is not comprehensive.

Please see the Full Prescribing Information here.

About Gozellix® (kit for the preparation of gallium Ga 68 gozetotide injection)

Gozellix, after radiolabeling with 68Ga, is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Risk for Misinterpretation

Image interpretation errors can occur with GOZELLIX PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga-68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Imaging Prior to Initial Definitive or Suspected Recurrence Therapy

The performance of GOZELLIX for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of GOZELLIX for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.

Radiation Risks

Gallium Ga-68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.

Hypersensitivity Reactions to Sulfites

Ascorbic Acid Stabilizer contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.

ADVERSE REACTIONS

The safety of gallium Ga-68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMABCR studies, each receiving one dose of gallium Ga-68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of 1%.

First Patients Dosed with Telix’s FDA-Approved Brain Cancer Imaging Drug Pixclara® (floretyrosine F 18)

Melbourne (Australia) and Indianapolis, IN (United States) | October 6, 2026

- First doses of Pixclara administered in Cleveland (OH) and Indianapolis (IN) marking the start of U.S. commercial availability.

- Pixclara is the only FDA-approved radiopharmaceutical imaging drug for glioma (brain cancer).

- Pixclara addresses a significant unmet need helping physicians differentiate recurrent or progressive glioma from treatment-related change in adult and pediatric patients 1 month of age and older.

Telix today announces that the first patients in the United States (U.S.) have been dosed with Pixclara® (floretyrosine F 18 or 18F-FET), its FDA-approved, amino acid positron emission tomography (PET) drug for glioma (brain cancer) imaging.

The doses were administered at the Indiana University Health (IU Health) Neuroscience Center in Indianapolis and the University Hospitals, Cleveland Medical Center, Cleveland. The milestone marks the start of commercial availability for Pixclara, with Telix’s U.S. manufacturing and pharmacy distribution partner, PharmaLogic Holdings Corp. (PharmaLogic), supplying finished unit doses to the U.S. market.

Pixclara is a radioactive diagnostic drug indicated for use with PET to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and pediatric patients one month of age and older.

Na Tosha N. Gatson, MD, PhD, FAAN, director of the Center for Neuro-Oncology as part of the Neuroscience & Cancer Institutes with IU Health-Indiana University School of Medicine; tenured professor, Neurology, Neurosurgery, & Medicine, IUSM, and Founding President of the nonprofit, Living Oncology said, “Distinguishing recurrent or progressive gliomas from treatment-related change is one of the most difficult and consequential challenges in brain cancer. Having access to FDA-approved FET-PET[1] imaging with Pixclara will help clinicians make more timely and accurate decisions, minimizing uncertainty in their diagnoses and supporting more confident treatment planning for patients with gliomas.”

Clement Pillainayagam, MD, Specialist in Neurology and Neuro-oncology, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Cleveland, added, “The approval and commercial availability of Pixclara represents an advance for patients with glioma in the U.S. FET-PET imaging is recommended in international clinical practice guidelines, including NCCN Guidelines[2], and having an FDA-approved, commercially available option can help translate this established clinical approach into broader access for patients, adding another tool to help in their care.”

Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, continued, “The first commercial dose of Pixclara is an important milestone for a patient community that has seen limited advances in diagnosis and treatment for many years. We are proud to support patients with glioma and their care teams by bringing this important new precision diagnostic to the U.S., and we thank the clinicians, patients, advocates and broader neuro-oncology community who helped make this possible.”

About gliomas

Gliomas are the most common form of central nervous system (CNS) cancer, accounting for approximately 30% of all brain and CNS tumors and 80% of all malignant brain tumors[3]. In the U.S., approximately 24,000 new glioma cases are diagnosed each year[4], representing a significant unmet addressable need.

About Pixclara (floretyrosine F 18)

Pixclara® is an intravenous positron emission tomography (PET) imaging drug for the differentiation of recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and pediatric patients 1 month of age and older. It comprises a small molecule targeting compound labeled with a diagnostic radioisotope, fluorine-18. After administration into the bloodstream, Pixclara targets membrane transport proteins known as L-type amino acid transporters 1 and 2 (LAT1 and LAT2). Once bound, energy emissions from the radioisotope can be detected by a PET scanner. Pixclara (TLX101-Px) is also the subject of a Phase 3 registrational study for potential indication expansion for the diagnosis of brain metastases[5].

Pixclara is the only FDA-approved radiopharmaceutical imaging drug for glioma (brain cancer).

INDICATIONS AND USAGE

PIXCLARA is indicated for use with positron emission tomography (PET) to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and pediatric patients 1 month of age and older.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Risk for Misinterpretation

Image misinterpretation may occur with PIXCLARA PET. A negative image does not rule out the presence of recurrent or progressive glioma and a positive image does not confirm the presence of recurrent or progressive glioma. Equivocal findings may occur with PIXCLARA PET, including low-level or atypical uptake patterns, which may result in false positive or false negative interpretations.

Interpret PIXCLARA PET findings with caution and correlate results with available clinical evaluations, such as histopathology, cross-sectional imaging, and/or clinical history to support appropriate clinical decision-making.

Radiation Risks

PIXCLARA contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe drug handling to protect patients and health care providers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

ADVERSE REACTIONS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of PIXCLARA was evaluated in 382 patients with gliomas. Among these 382 patients, 371 adult patients received at least one intravenous dose of PIXCLARA at a mean activity of 204 ± 18 MBq (5.5 ± 0.47 mCi). The remaining 11 pediatric patients received at least one intravenous dose of PIXCLARA at a mean activity of 155 ± 53.5 MBq (4.2 ± 1.4 mCi).

The mean age of the patients was 57 years (range: 5 years to 86 years). Sex was 59% male, 37% female, and 3% unreported. Distribution by race was 26% White, 6% Asian, 1% Black or African American, and 67% other or unreported. Distribution by ethnicity was 3% Hispanic/Latino, 96% non-Hispanic/Latino, and 1% unknown or unreported.

Adverse reactions that occurred in ≥0.5% of patients receiving PIXCLARA were headache (0.5%).

Adverse reactions that occurred in 0.5% of patients were nausea, injection site reaction, fatigue, and malaise.

Adverse Reactions in Pediatric Patients

Overall, the safety profile observed in pediatric patients from the clinical study was consistent with the safety profile in adult patients.

Please note that this information is not comprehensive.

Please see the Full Prescribing Information at https://telixpharma.com/wp-content/uploads/2026/09/USPI_PIXCLARA_Sep2026.pdf

You are encouraged to report suspected adverse reactions of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix Pharmaceuticals (US) by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com.

[1] Imaging of floretyrosine F 18 with positron emission tomography.

[2] Galldiks et al. Lancet Oncol. 2025 (Joint guidelines from the European Association of Nuclear Medicine (EANM), European Association of Neuro-Oncology (EANO), Society of Nuclear Medicine and Molecular Imaging (SNMMI), Response Assessment in Neuro-Oncology (RANO), The European Society for Pediatric Oncology and The Response Assessment in Pediatric Neuro-Oncology for the characterization of recurrence in glioma patients); National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Central Nervous System Cancers V3.2026.

[3] Goodenberger et al. Cancer Genet. 2012.

[4] CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2018-2022. Neuro-Oncology. 2025.

[5] Investigational New Drug (IND) application successfully cleared, with Study May Proceed notification received from FDA. Telix ASX disclosure August 20, 2026.

Telix to Host Capital Markets Day in Melbourne on November 4, 2026

Melbourne (Australia) and Indianapolis, IN (United States) | October 9, 2026

Telix today advises that it will host a Capital Markets Day in Melbourne, Australia, on Wednesday, November 4, 2026, from 9:00 a.m. to 12:30 p.m. (AEDT).

Institutional investors and analysts are invited to attend the in-person event, which will provide an update on Telix’s commercial portfolio, late-stage pipeline and strategic growth opportunities. Members of the Telix leadership team will present at the event, which will also feature key opinion leaders who will provide their perspectives on Telix’s theranostic programs.

Advance registration is required for in-person attendance. To register your interest please contact charlene.jaw@telixpharma.com or annie.kasparian@telixpharma.com.

The event will be webcast live and available via the Investor Relations section of the Telix website.

Telix Highlights Pivotal Trials in Prostate, Brain and Renal Cancers and Next Generation Theranostics at EANM

Melbourne (Australia) and Indianapolis, IN (United States) | October 14, 2026

Telix today announces that 20 company-related abstracts will be presented at the 39th Annual Congress of the European Association of Nuclear Medicine (EANM) to be held in Vienna, Austria from October 17-21, 2026.

Dr. David N. Cade, Telix Group Chief Medical Officer, said, “Our expansive presence at EANM reflects the breadth and maturity of Telix’s pipeline, spanning pivotal therapeutic studies, precision diagnostics and next-generation technologies. The selection of 12 abstracts for top-rated oral presentations is a strong recognition of the quality and clinical relevance of this work. We look forward to continuing this discussion at our sponsored symposium on the future of theranostics in urologic oncology.”

Key presentations include the Phase 3 IPAX BrIGHT trial of TLX101-Tx in recurrent glioblastoma, the Phase 3 LUTEON trial of TLX250-Tx in ccRCC, and interim results from the PTherpan-Lu trial of TLX597-Tx in mAPMR prostate cancer[1]. Topline Phase 3 data for TLX591-Px (Illuccix) PET[2] imaging of prostate cancer in Chinese men will also be presented, together with real-world experience with TLX250-Px (Zircaix[3]) in ccRCC, and research from our targeted alpha therapy and MedTech programs. As in previous years, Telix will support the EANM Sanjiv Sam Gambhir Young Investigator Award, in memory of an extraordinary man and inspiring educator.

Visit booth #527 to explore opportunities for collaboration with Illuccix® (kit for the preparation of gallium-68 gozetotide injection), Telix’s commercial PSMA-PET imaging[4] agent in Europe; our theranostic pipeline; and our medical technologies, including the SENSEI® miniature drop-in gamma probe, QDOSE® dosimetry software and artificial intelligence (AI).

EANM presentation details are as follows (all times CEST):

SPONSORED SYMPOSIUM

Title: The future doesn’t wait: The next era of theranostics in urologic oncology.

Date & Time: 18-Oct-26, 13:15 – 14:45

Location: Hall F2, Austria Center Vienna

Chair: J. Calais, Gustave Roussy, IGR and Université Paris-Saclay, Paris, France

Agenda:

The theranostic revolution

- J. Calais

The evolving role of PSMA-PET in prostate cancer

- K. Herrmann, University Hospital Essen, Germany

- M. Ghesani, United Theranostics, USA

Next-generation PSMA therapeutics: Overcoming today’s challenges

- D. Oprea-Lager, Radboud University Medical Center, Nijmegen, the Netherlands

- L. Emmett, St Vincent’s Hospital, Sydney, Australia

Panel discussion – all

Extending prostate cancer theranostic success to broader GU diseases

- J. Calais

ORAL PRESENTATIONS

Title: ELEGANCE, Prospective pilot study, assessing imaging performance of TLX250-Px ([⁸⁹Zr]Zr-girentuximab) PET/CT in Patients with Hepatocellular Carcinoma, Biliary Tract Cancer or Gastro-Entero-Pancreatic Neuroendocrine Neoplasms (NCT06735560)

Date and Time: 18-Oct-26, 08:00 – 09:30

Presenter: Clement Bailly, CHU Nantes

Abstract #: OP-036

Title: HIMIKO, TLX591-Px ([⁶⁸Ga]Ga-PSMA) PET/CT in Hepatocellular Carcinoma: impact of Multiparametric dynamic whole-body imaging and kinetic modelling (NCT06999837)

Date and Time: 18-Oct-26, 08:00 – 09:30

Presenter: Rachel Bardy, CHU Nantes

Abstract #: OP-041

Title: Exploring carbonic anhydrase IX as a diagnostic imaging target using TLX250-Px ([⁸⁹Zr]Zr-girentuximab) in Von Hippel-Lindau Disease: preliminary results from the CAT-VHL Phase 2 trial (NCT07171905)

Date and Time: 18-Oct-26, 15:00 – 16:30

Presenter: Fabrizia Gelardi, San Raffaele Hospital

Abstract #: OP-168

Title: LUTEON, Phase 3 study to assess safety and efficacy of TLX250-Tx (¹⁷⁷Lu-girentuximab) in advanced, relapsed or recurrent ccRCC (NCT07197580)

Date and Time: 18-Oct-26, 15:00 – 16:30

Presenter: Ghoufrane Tlili, CHU Bordeaux

Abstract #: OP-170

Title: Building the traceability backbone for radiopharmaceutical therapy, first results from the PDIB Secondary Standards Laboratory Network

Date and Time: 19-Oct-26, 08:00 – 09:30

Presenter: Steven Graves, University of Iowa

Abstract #: OP-291

Title: Optimizing SPECT/CT for alpha emitters: Phantom validation and calibration of [²¹¹At] imaging

Date and Time: 19-Oct-26, 08:00 – 09:30

Presenter: Rob van Rooij, UMC Utrecht

Abstract #: OP-294

Title: IODO-RISE, TLX101-Tx (iodofalan-¹³¹I) in recurrent high-grade glioma, investigation of safety and efficacy

Date and Time: 19-Oct-26, 08:00 – 09:30

Presenter: Tim Sturre, UMC Utrecht

Abstract #: OP-311

Title: IPAX BrIGHT, Pivotal study of TLX101-Tx (iodofalan-¹³¹I) with or without lomustine vs lomustine alone for the treatment of patients with radiographically confirmed recurrent glioblastoma at first recurrence (NCT07100730)

Date and Time: 19-Oct-26, 08:00 – 09:30

Presenter: Nelleke Tolboom, UMC Utrecht

Abstract #: OP-312

Title: Comparative evaluation of TLX252-Tx ([²²⁵Ac]Ac-) and TLX250-Tx ([¹⁷⁷Lu]Lu-DOTA-hG250) targeted radionuclide therapy and combination with PD1 blockade in a preclinical renal cell carcinoma model

Date and Time: 19-Oct-26, 16:45 – 18:15

Presenter: Twan van der Werff, UMC Radboud

Abstract #: OP-478

Title: Interim results from PTherpan-Lu trial: TLX597-Tx ([¹⁷⁷Lu]Lu-panPSMA) radionuclide therapy for patients with mCRPC[5]

Date and Time: 19-Oct-26, 16:45 – 18:15

Presenter: Yehia Omar, Misr Radiology

Abstract #: OP-523

Title: Integration of spatial analysis and deep learning for enhanced tumor classification in total-body PET/CT imaging: using residual deep learning with spatial feature augmentation and cross-validated ensemble learning

Date and Time: 20-Oct-26, 09:45 – 11:15

Presenter: Simon Wail, Telix Pharmaceuticals

Abstract #: OP-613

Title: TLX250-Px ([⁸⁹Zr]Zr-girentuximab) PET/CT for characterization of indeterminate renal masses, diagnostic performance and clinical impact in a real-world cohort

Date and Time: 20-Oct-26, 09:45 – 11:15

Presenter: Sazan Rasul, Medical University of Vienna

Abstract #: OP-627

POSTERS

Title: QDOSE® allometry-guided human dosimetry of TLX102-Tx ([²¹¹At]APA): Impact of administration route on maximum tolerated activity

Abstract #: EP-0067

Title: Illuccix China, preliminary results from Phase 3 trial of TLX591-Px (⁶⁸Ga-PSMA-11) PET for detection of biochemical recurrence of prostate cancer in Chinese men (NCT05847348)

Abstract #: EP-0460

Title: TLX250-Px (⁸⁹Zr-girentuximab) PET/CT in Von Hippel Lindau disease; initial real-world experience in VHL expert center

Abstract #: EP-0595

Title: TLX250-Px (⁸⁹Zr-girentuximab) PET/CT in clear cell renal cell carcinoma, impact on staging and clinical management

Abstract #: EP-0599

Title: Impact of TLX250-Px (⁸⁹Zr-girentuximab) based radionuclide imaging in patients with renal cell carcinoma on virtual tumor board decision making

Abstract #: EP-0606

Title: A semi-mechanistic population biodistribution model of TLX250-Px (⁸⁹zr-girentuximab) for the diagnosis of clear cell renal cell carcinoma

Abstract #: EP-0999

Title: Potential for radioguided surgery based on internal conversion electron detection using a compact CMOS detector

Abstract #: EP-1070

Title: A dosimetric study of bladder endocavitary therapy using astatine-211

Abstract #: EP-1239

With the exception of Illuccix, all products mentioned in this release are for investigational use only and have not received a marketing authorization in any jurisdiction.

[1] Metastatic androgen pathway modulation-resistant prostate cancer (formerly known as metastatic castration-resistant prostate cancer, or mCRPC).

[2] Positron emission tomography.

[3] Brand name subject to final regulatory approval.

[4] Imaging of prostate-specific membrane antigen with positron emission tomography.

[5] Also known as mAPMR.

Telix and Ekalia to Collaborate on Astatine-211 Production in the U.S.

Melbourne (Australia), Louvain-la-Neuve (Belgium), Paris (France) and Indianapolis, IN (U.S.) | October 19, 2026

• Collaboration establishes a framework for a dedicated U.S. source of astatine-211 (211At), a scarce, next-generation alpha-emitting isotope with significant potential in targeted alpha therapy (TAT).

• Secures long-term, priority isotope access for Telix’s alpha therapy pipeline, including its TLX102-Tx candidate for glioblastoma and leptomeningeal disease, while also supporting third-party academic and industry programs.

• First IBA alpha-beam cyclotron to be installed and operated at Telix’s RLS Radiopharmacies site near Philadelphia, PA.

• Leverages Telix’s vertically integrated U.S. manufacturing and distribution platform, with a framework providing for the parties to evaluate additional installations at RLS sites as demand for 211At develops.

Telix and Ekalia, a joint venture between IBA (Ion Beam Applications S.A., EURONEXT) and Framatome, today announced a collaboration to advance scalable United States (U.S.) production of astatine-211 (211At), an alpha-emitting radioisotope being investigated for targeted alpha therapy.

The collaboration brings together IBA’s specialized alpha-beam cyclotron technology, Framatome’s nuclear and isotope production expertise, and Telix’s U.S. radiopharmacy and “last-mile” infrastructure, clinical portfolio and radiopharmaceutical development capabilities. The alliance expands into the U.S. the strategic partnership formed by IBA and Framatome in Europe to advance industrial-scale ²¹¹At production. The first installation at RLS Trevose is intended to establish a reproducible production model, with the potential for further rollout across the RLS network as demand develops.

Astatine-211 is recognized as a promising alpha-emitting radioisotope for the development of innovative cancer treatments[1]. However, its broader adoption remains constrained by the availability of sufficient production capacity[2]. The collaboration is intended to improve robust, reliable, and timely access to 211At for research and clinical development through a network of production sites in close proximity to clinical centers, helping to further establish theranostics as a cornerstone of precision oncology.

For Telix, the collaboration is expected to support the development of several early-stage therapeutic candidates, including TLX102-Tx (211At astato-L-phenylalanine), a TAT being evaluated for glioblastoma and leptomeningeal disease, as well as future 211At programs. The collaboration is also intended to provide production capacity for third-party academic and industry programs, helping to expand the U.S. 211At development ecosystem.

Bruno Scutnaire, CEO of Ekalia (company in formation) said: “IBA’s specialized alpha-beam cyclotron technology is designed to enable reliable astatine-211 production at the point of need. Building on our work with Framatome in Europe, Telix’s U.S. infrastructure enables us to move faster towards establishing our first U.S. production unit, while laying the foundations for Ekalia’s broader development in the country.”

Chad Watkins, General Manager, Isotope Strategy at Telix, continued: “Owning the path from isotope to patient is central to our development and commercialization strategy. This collaboration gives Telix a dedicated, long-term source of astatine-211 to advance our alpha therapy pipeline, and demonstrates the strategic value of the RLS platform as a host for next-generation isotope production in the U.S. We are delighted to partner with IBA and Framatome, two global leaders in this field, to help advance reliable, scalable astatine-211 production.”

[1] Lindegren et al. EJNMMI Radioph. and Chem. (2026) 11, 15 doi:10.1186/s41181-026-00428-0

[2] Albertsson P et al; Frontiers in Med (2023),9, 1076210: doi:10.3389/fmed.2022.1076210.

OPEC Under Threat: UAE Exit Could Change Oil Markets Forever | Watch | Business News | ET Now

Updated Apr 28, 2026 20:35 IST

OPEC Under Threat: UAE Exit Could Change Oil Markets Forever | Watch | Business News | ET NowThe UAE’s reported exit from the OPEC+ alliance has sparked a major debate in global oil markets.Experts like Peter Cardillo say this could be the first sign of cracks within OPEC, raising questions about the cartel’s long-term future.Meanwhile, energy expert Narendra Taneja believes a weaker OPEC may actually benefit India, allowing for better bilateral oil deals.Key questions:Will oil prices fall if OPEC weakens?Is this the beginning of the end for oil cartels?What does this mean for India, the world’s fastest-growing oil demand center?Watch this detailed discussion to understand the global oil market shift.#opec #uae #oilprices #crudeoil #energymarket #indiaeconomy #globalmarkets #oilnews #geopolitics #businessnews #etnow #energycrisis #opecplus #marketupdate #oiltrade

OPEC Under Threat: UAE Exit Could Change Oil Markets Forever

April 28, 2026

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