Telix Submits European Marketing Authorization Application for TLX101-Px for Brain Cancer Imaging

Rhea-AI Summary

Telix (ASX: TLX, NASDAQ: TLX) submitted a European marketing authorization application (MAA) on Feb 18, 2026 for TLX101-Px (18F-FET) for glioma imaging, covering major European markets.

The company said the EU filing was advanced alongside its U.S. regulatory package; a U.S. NDA resubmission will follow. TLX101-Px is positioned to improve differentiation of glioma progression versus treatment effects and to support Telix’s glioblastoma therapy program.

Positive

• MAA submitted for TLX101-Px covering major European markets
• Alignment with U.S. package to expedite regulatory filings
• Supports Phase 3 therapy program via patient selection for TLX101-Tx
• TLX101-Tx has orphan drug designation in Europe and the U.S.
• Phase 3 IPAX-BrIGHT trial launching in multiple European countries

Negative

• No European approval yet; submission does not equal authorization
• Current FET-PET availability limited to hospital-based production sites
• U.S. NDA resubmission timing remains forthcoming

Key Figures

IPAX-BrIGHT phase: Phase 3 TLX101-Px radionuclide: 18F TLX101-Tx radionuclide: 131I

3 metrics

IPAX-BrIGHT phase Phase 3 IPAX-BrIGHT trial for recurrent glioblastoma

TLX101-Px radionuclide 18F O-(2-[18F]fluoroethyl)-L-tyrosine PET tracer

TLX101-Tx radionuclide 131I Iodofalan 131I therapeutic candidate TLX101-Tx

Market Reality Check

Price: $6.42 Vol: Volume 278,705 vs 20-day ...

high vol

$6.42 Last Close

Volume Volume 278,705 vs 20-day avg 181,438 (relative volume 1.54). high

Technical Trading well below 200-day MA of 11.66 with price at 6.42, near the 52-week low of 6.34 and far from the 52-week high of 30.36.

Peers on Argus

TLX was up 1.71% while close peers showed mixed moves (e.g., RARE -2.28%, MLTX +...

1 Up

TLX was up 1.71% while close peers showed mixed moves (e.g., RARE -2.28%, MLTX +11.03%). Only one momentum-peer (ADMA, +4.39%) screened higher, supporting a stock-specific move rather than a broad biotech rotation.

Historical Context

5 past events · Latest: Feb 03 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 03	Results webcast notice	Neutral	-0.1%	Announcement of FY 2025 results date and investor webcast scheduling.
Jan 20	FY 2025 revenue update	Positive	-0.4%	Reported FY 2025 revenue of US$804M and strong Q4 growth with Gozellix launch.
Jan 16	BiPASS Phase 3 dosing	Positive	+4.4%	First U.S. patient dosed in BiPASS Phase 3 pre-biopsy prostate cancer study.
Jan 08	JPM conference presentation	Positive	+1.7%	Announcement of pipeline and portfolio presentation at J.P. Morgan conference.
Dec 21	Precision imaging update	Positive	+3.2%	Positive TLX591-CDx China Phase 3 data and TLX101-/TLX250-CDx FDA interactions.

Pattern Detected

Recent Telix news has generally been positive (revenue beats, clinical progress), with the stock more often reacting positively; one notable divergence followed a strong FY 2025 revenue update.

Recent Company History

Over the past few months, Telix has highlighted several milestones. On Dec 21, 2025, it reported strong TLX591-CDx Phase 3 data and FDA interactions for TLX101-CDx and TLX250-CDx, with the stock up 3.21%. A BiPASS Phase 3 prostate cancer study dosing update on Jan 16, 2026 saw a 4.44% rise. FY 2025 revenue of US$804M and Q4 revenue of US$208M (reported Jan 20, 2026) led to a small -0.39% move. The current European MAA for TLX101-Px extends this pattern of regulatory and clinical advancement in precision imaging.

Market Pulse Summary

This announcement highlights a key regulatory step as Telix submits a European MAA for TLX101-Px in ...

Analysis

This announcement highlights a key regulatory step as Telix submits a European MAA for TLX101-Px in glioma imaging, with a U.S. NDA to follow. It builds on recent revenue growth and multiple late-stage imaging and therapy programs, including the Phase 3 IPAX-BrIGHT trial. Investors may focus on approval timelines, eventual label breadth, and how TLX101-Px supports the TLX101-Tx franchise within Telix’s broader precision radiopharmaceutical portfolio.

Key Terms

marketing authorization application, maa, new drug application, nda, +4 more

8 terms

marketing authorization application regulatory

"announces that it has submitted a marketing authorization application (MAA) in Europe"

A marketing authorization application is a formal request submitted to a government regulator asking permission to sell a prescription medicine or medical product in a country or region. Think of it like asking for a business license after showing evidence the product is safe and works; investors care because approval determines whether the product can generate sales, how soon revenue starts, and how much regulatory risk and uncertainty remains.

maa regulatory

"submitted a marketing authorization application (MAA) in Europe for TLX101-Px"

MAA stands for Marketing Authorization Application, the formal request a drug developer files with regulators (commonly in the European Union) asking for permission to sell a medicine. Think of it like applying for a driver’s license for a product: approval means the company can market and earn revenue from the drug, while rejection or delays affect expected sales, timelines and the company’s valuation—so investors track MAAs as key risk/reward milestones.

new drug application regulatory

"Submission of the U.S. New Drug Application (NDA) will follow."

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

nda regulatory

"Submission of the U.S. New Drug Application (NDA) will follow."

An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.

positron emission tomography medical

"In Europe, positron emission tomography (PET) imaging of glioma with 18F-FET"

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.

pet medical

"positron emission tomography (PET) imaging of glioma with 18F-FET (FET-PET)"

Positron emission tomography (PET) is a medical imaging test that creates a live map of how organs and tissues are working by tracking a tiny, safe amount of radioactive tracer inside the body. For investors, PET matters because it’s often used in clinical trials and diagnosis to show whether a drug or treatment is affecting disease — think of it as a performance meter that can speed regulatory decisions, change market forecasts, and affect a product’s commercial value.

orphan drug designation regulatory

"TLX101-Tx (iodofalan 131I), which has been granted orphan drug designation in Europe"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

radiopharmaceuticals medical

"authorized targeted radiopharmaceuticals for brain cancer imaging and therapy"

Radiopharmaceuticals are medicines that carry tiny amounts of radioactive material to help doctors see or treat disease inside the body, acting like a tracer dye for imaging or a microscopic guided missile for targeted therapy. They matter to investors because their safety, regulatory approval, production complexity, short shelf life and hospital reimbursement determine how quickly they can reach patients and generate revenue, affecting a company’s sales potential and risk profile.

AI-generated analysis. Not financial advice.

MELBOURNE, Australia and INDIANAPOLIS, Feb. 18, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that it has submitted a marketing authorization application (MAA) in Europe for TLX101-Px (O-(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 guidelines². 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 need³. 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 countries⁴.

Philipp Lohmann, Group Leader Digital Translational Neuroimaging at Forschungszentrum Jülich research center in Germany, commented, “FET-PET imaging is already used in clinical practice in Europe for the evaluation of gliomas, and plays a critical role in treatment decision making. This applies particularly in the post-therapy setting, where conventional MRI⁵ alone can be limited in its ability to distinguish tumor progression from treatment-related changes. Having widespread access to TLX101-Px has potential to provide clinicians with greater biological insight, supporting more confident and timely management of patients with brain tumors.”

Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, added, “We see a compelling opportunity in Europe to broaden access to authorized targeted radiopharmaceuticals for brain cancer imaging and therapy, and as such this submission is an important milestone for Telix. The strategic value of this submission is particularly relevant to establishing widespread glioma imaging as part of our corresponding therapeutic development program. We have been able to utilize aspects of our FDA package to expedite the European filing, which has been submitted in accordance with a pre-defined date agreed with the regulator, with the U.S. resubmission to follow.”

About glioma in Europe

In Europe, approximately 67,500 brain and central nervous system tumors are diagnosed every year⁶, with gliomas accounting for approximately 30% of these, and up to 80% of all malignant brain tumors⁷. There is a critical unmet need to improve the diagnosis and management of gliomas, which are the most common primary brain tumors of the central nervous system, particularly in the post-treatment setting⁵. Conventional MRI imaging techniques have several limitations, including a lack of biological specificity, dependency on blood-brain barrier disruption, and an inherent inability to differentiate between tumor 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 paramount⁵. Subject to regulatory approval, TLX101-Px has the potential to address this need, enabling patients in Europe to receive greater clarity in their diagnosis and treatment decision making.

About TLX101-Px

TLX101-Px (O-(2-[¹⁸F]fluoroethyl)-L-tyrosine) is Telix’s PET imaging candidate for the characterization of glioma. TLX101-Px targets membrane transport proteins known as L-type amino acid transporters 1 and 2 (LAT1 and LAT2). This enables TLX101-Px to be potentially utilized as a complementary diagnostic agent to TLX101-Tx (iodofalan ¹³¹I), Telix’s LAT1-targeting investigational glioblastoma (GBM) therapy, currently under investigation in Telix’s IPAX-2⁹ and IPAX-BrIGHT⁶ studies. TLX101-Px and TLX101-Tx have not received a marketing authorization in any jurisdiction. In relevant European markets, the proposed brand name for TLX101-Px is “Pixlumi®”. Brand name and commercial launch are subject to final regulatory approval.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, 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. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.

Telix Investor Relations (Global)

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com

This announcement has been authorized for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.

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 the planned NDA resubmission for TLX101-Px and the planned BLA resubmission for TLX250-Px, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

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 The French National Agency for Medicines and Health Products Safety (ANSM), in its capacity as Reference Member State, is responsible for coordinating and leading the scientific evaluation of the dossier, in collaboration with the concerned Member States, nominated by Telix and representing the major European markets for Telix’s brain cancer imaging product.
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 V1.2025.
³ Albert et al. Lancet Oncol. 2024.
⁴ ClinicalTrials.gov ID: NCT07100730.
⁵ Magnetic Resonance Imaging.
⁶ Frosina et al. Sci Rep. 2024.
⁷ Goodenberger et al. Cancer Genetics. 2012.
⁸ Smith et al. J Nucl Med. 2023.
⁹ ClinicalTrials.gov ID: NCT05450744.

FAQ

What did Telix (TLX) announce on Feb 18, 2026 about TLX101-Px?

Telix announced it submitted a European MAA for TLX101-Px on Feb 18, 2026. According to the company, the filing covers major European markets and was advanced alongside its U.S. regulatory package.

Will the TLX101-Px submission to Europe change current FET-PET access for glioma?

Telix expects broader access to standardized FET-PET imaging across Europe if authorized. According to the company, TLX101-Px aims to replace limited hospital-only production with a commercial product ensuring consistent quality and availability.

How does the TLX101-Px MAA relate to Telix’s TLX101-Tx therapy (TLX)?

TLX101-Px is being developed to select and monitor patients for TLX101-Tx therapy. According to Telix, the imaging agent supports patient selection and response assessment alongside the Phase 3 IPAX-BrIGHT trial.

Does TLX101-Tx have any regulatory designations relevant to investors in TLX?

Yes. TLX101-Tx has been granted orphan drug designation in Europe and the U.S. According to Telix, this designation applies to their glioblastoma therapy program tied to TLX101-Px development.

Has Telix submitted a U.S. NDA for TLX101-Px alongside the European MAA?

Telix has not completed the U.S. NDA; a U.S. resubmission will follow the European filing. According to the company, aspects of the FDA package were used to expedite the European MAA.

What clinical need does TLX101-Px address for glioma imaging in Europe?

TLX101-Px aims to help distinguish tumor progression from treatment-related changes in adults and children. According to Telix, FET-PET provides biological insight where MRI alone can be limited, particularly post-therapy.