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

PharmaLogic is supplying finished unit doses to the U.S. market for use in adults and children one month and older.

Rhea-AI Summary

Telix Pharmaceuticals (TLX) has begun U.S. commercial availability of Pixclara, its FDA-approved brain cancer imaging drug, with the first patients dosed. Doses were administered at IU Health Neuroscience Center in Indianapolis and University Hospitals Cleveland Medical Center. Manufacturing and pharmacy distribution partner PharmaLogic is supplying finished unit doses to the U.S. market.

Pixclara is used with positron emission tomography (PET) to distinguish recurrent or progressive glioma from treatment-related changes, alongside other diagnostic evaluations, in adults and children one month and older. A Phase 3 registrational study is evaluating potential expansion to diagnosing brain metastases. Label warnings include possible false positive or false negative interpretations and cumulative radiation exposure associated with increased cancer risk.

3 points · 0 major

PositiveiHow this balance works

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

How the balance worksHow Sentiment works

0 major · 1 point

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointPixclara U.S. commercial availability began with first patients dosed in Indianapolis and Cleveland.
• Minor pointFDA-approved glioma imaging indication covers adults and pediatric patients one month of age and older.
• Minor point. Forward-looking: it has not happened yet and may not happen.Phase 3 registrational study is evaluating potential indication expansion to diagnosis of brain metastases.

Negative

• Minor pointPixclara label warnings include image misinterpretation and cumulative radiation exposure associated with increased cancer risk.

Key Figures

Safety evaluation population: 382 patients Headache incidence: 0.5% Minimum patient age: 1 month

Safety evaluation population

382 patients

Patients with gliomas; PIXCLARA clinical-trial safety evaluation

Headache incidence

0.5%

Adverse reaction reported among patients receiving PIXCLARA

Minimum patient age

1 month

Indicated adult and pediatric patient population

Historical Context

1 past event · Latest: Sep 14

1 event

1. Sep 14

   FDA approval

   24h Move

   +4.4%

   FDA approval established U.S. authorization before today's first commercial doses.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

glioma, radiopharmaceutical, positron emission tomography, radioisotope, +1 more

5 terms

glioma medical

"for glioma (brain cancer) imaging."

A glioma is a type of tumor that begins in the brain or spinal cord’s support cells (glial cells) rather than in nerve cells themselves. Investors watch glioma closely because its diagnosis, treatment progress, and clinical trial results can drive the value of companies developing medicines, diagnostics, or devices for these tumors; think of it like a problem in a factory’s supporting infrastructure that can prompt costly fixes or create profitable opportunities for suppliers.

radiopharmaceutical medical

"the only FDA-approved radiopharmaceutical imaging drug for glioma"

A radiopharmaceutical is a special type of medicine that contains a small amount of radioactive material, used primarily for medical imaging or treatment. It can be thought of as a tiny, targeted signal that helps doctors see inside the body or deliver therapy directly to affected areas. For investors, understanding radiopharmaceuticals is important because they represent a growing field within healthcare, driven by advancements in diagnostics and personalized treatments.

positron emission tomography medical

"amino acid positron emission tomography (PET) drug for glioma imaging"

A positron emission tomography (PET) scan is an imaging test that uses a tiny amount of radioactive tracer injected into the body to map how organs and tissues are functioning, similar to watching traffic flow on a city map rather than just seeing roads. Investors care because PET technology and the tracers it uses are critical in developing and measuring the effectiveness of drugs, diagnosing diseases, and guiding treatment decisions, which can drive demand, regulatory scrutiny, and revenue for related healthcare companies.

radioisotope medical

"labeled with a diagnostic radioisotope, fluorine-18."

A radioisotope is an unstable form of an atom that releases energy as it changes into a more stable form; imagine a tiny battery that slowly discharges radiation instead of electricity. Investors care because these materials power widely used medical tests and treatments, industrial devices, and scientific tools, so their availability, production costs, safety rules and transport limits can directly affect company revenue, supply chains and regulatory risk.

l-type amino acid transporters medical

"L-type amino acid transporters 1 and 2 (LAT1 and LAT2)."

A family of cell membrane proteins (also called system L transporters, notably LAT1 and LAT2) that move large neutral amino acids across cell membranes without using sodium. They work as facilitative exchangers—often forming a functional complex with a heavy-chain partner (4F2hc/CD98) to reach the cell surface—and transport one neutral amino acid into the cell in exchange for another leaving, so transport is driven by amino acid gradients rather than by ATP or ion pumps. These transporters are important for supplying essential amino acids to tissues such as the brain and placenta and are frequently upregulated in rapidly dividing cells; they are sodium-independent and require the heavy-chain subunit for membrane localization.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

• 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.
  

MELBOURNE, Australia and INDIANAPOLIS, Oct. 06, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “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-PET¹ 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 Guidelines², 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 tumors³. In the U.S., approximately 24,000 new glioma cases are diagnosed each year⁴, 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 metastases⁵.

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.

About Telix Pharmaceuticals Limited

Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX) is a commercial-stage global radiopharmaceutical company, advancing targeted theranostics to improve outcomes for people with cancer across the patient journey. Theranostics pairs a precision diagnostic with a targeted therapy to both diagnose and treat disease.

Telix's commercial franchise is anchored by its precision diagnostics portfolio: Illuccix® (kit for the preparation of gallium-68 gozetotide injection), commercially available in 22 countries including the U.S., and Gozellix® (kit for the preparation of gallium-68 gozetotide injection), approved by the U.S. Food and Drug Administration (FDA) for prostate imaging, and Pixclara® (floretyrosine F 18) approved by the FDA for glioma imaging. The Company's late-stage therapeutic pipeline includes three investigational assets in pivotal-stage trials: TLX591-Tx (lutetium-177 (¹⁷⁷Lu) rosopatamab tetraxetan) in prostate cancer, TLX101-Tx (iodofalan ¹³¹I) in recurrent glioblastoma, and TLX250-Tx (lutetium (¹⁷⁷Lu) girentuximab tetraxetan) in kidney cancer, additionally complemented by a deep pipeline of next generation candidates. TLX591-Tx, TLX101-Tx and TLX250-Tx have not received marketing authorizations in any jurisdiction.

Telix is headquartered in Melbourne, Australia, with operations across North America, Europe, Latin America and Asia-Pacific. For more information, visit www.telixpharma.com or follow Telix on LinkedIn, X and Facebook.

Investor Relations	Media
Annie Kasparian annie.kasparian@telixpharma.com	Eliza Schleifstein
Charlene Jaw charlene.jaw@telixpharma.com	917.763.8106 (Mobile)
	Eliza@schleifsteinpr.com

Legal Notices

Cautionary Statement Regarding Forward-Looking Statements. 

You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification.  To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.

This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress, completion and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, including manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business, including as a result of war or other geopolitical conflicts; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties.

©2026 Telix Pharmaceuticals Limited. All rights reserved.

---

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.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

Is Telix’s Pixclara commercially available in the United States?

Pixclara is commercially available in the United States, with the first patients dosed at IU Health Neuroscience Center in Indianapolis and University Hospitals Cleveland Medical Center. PharmaLogic, Telix’s U.S. manufacturing and pharmacy distribution partner, is supplying finished unit doses.

What is Telix’s Pixclara approved to diagnose?

Pixclara is FDA-approved for use with positron emission tomography (PET) to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations. The indication covers adults and pediatric patients one month of age and older.