TLX101-Px (Pixlumi®) MAA Accepted in Europe
Rhea-AI Summary
Telix (ASX/NASDAQ: TLX) announced European validation and acceptance of its MAA for TLX101-Px (18F-FET) for glioma PET imaging. The application enters a 210-day active assessment covering major European markets. Telix said national approvals would follow after a positive Day-210 outcome.
The company noted no widely available commercial 18F-FET PET product exists in Europe and linked TLX101-Px to patient selection for its Phase 3 TLX101-Tx program.
AI-generated analysis. Not financial advice.
Positive
- MAA acceptance for TLX101-Px entering a 210-day review
- Coverage includes commercially significant European markets
- Addresses currently absent commercial 18F-FET PET product in Europe
- TLX101-Px aligned with Phase 3 TLX101-Tx patient selection
Negative
- Regulatory outcome still pending at Day 210
- Approval-dependent timing for national marketing authorizations
News Market Reaction – TLX
On the day this news was published, TLX gained 2.36%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
TLX was roughly flat at -0.10%, while peers like LGND and ZLAB gained 2.05% and 2.71%, suggesting today’s EU MAA news was stock-specific rather than part of a sector-wide move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Apr 27 | Educational webinar | Positive | +0.4% | Announcement of PSMA therapy webinar covering OPTIMAL-PSMA2 TLX597-Tx data. |
| Apr 21 | ASCO late-breaker | Positive | +1.2% | ProstACT Global Phase 3 Part 1 selected as late-breaking ASCO 2026 presentation. |
| Apr 14 | Phase 3 trial start | Positive | -0.4% | First patient dosed in Phase 3 IPAX-BrIGHT trial of TLX101-Tx for glioblastoma. |
| Apr 13 | FDA NDA accepted | Positive | +6.6% | FDA acceptance of resubmitted NDA for TLX101-Px with defined PDUFA goal date. |
| Apr 09 | Strategic collaboration | Positive | +7.5% | Regeneron collaboration with US$40M upfront and up to US$2.1B milestones. |
Recent positive regulatory and partnership news has usually aligned with positive price reactions, with one minor divergence on a Phase 3 trial milestone.
Over the last month, Telix reported multiple milestones: an FDA NDA acceptance for TLX101-Px with a September 11, 2026 PDUFA date, a strategic collaboration with Regeneron featuring up to US$2.1 billion in milestones, initiation of the Phase 3 IPAX-BrIGHT trial for TLX101-Tx, ASCO 2026 Phase 3 prostate cancer data, and an educational PSMA webinar. Today’s European MAA acceptance for TLX101-Px extends this regulatory and clinical momentum in glioma imaging.
Market Pulse Summary
This announcement advances Telix’s glioma imaging strategy, with the TLX101-Px MAA now in a 210-day European assessment phase and a U.S. NDA already tied to a September 11, 2026 PDUFA date. Combined with the Phase 3 IPAX-BrIGHT trial of TLX101-Tx and prior revenue growth of US$240 million in Q2 2025, the news highlights an expanding radiopharmaceutical portfolio. Key watchpoints include EU review outcomes and clinical data readouts.
Key Terms
marketing authorization application regulatory
pet medical
orphan drug designation regulatory
phase 3 medical
new drug application regulatory
pdufa goal date regulatory
convertible bonds financial
transitional pass-through status regulatory
AI-generated analysis. Not financial advice.
MELBOURNE, Australia and INDIANAPOLIS, May 01, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that the marketing authorization application (MAA) filed in Europe for TLX101-Px (O-(2-[18F]fluoroethyl)-L-tyrosine, 18F-FET), its glioma (brain cancer) imaging candidate1, has been validated and accepted for review.
The application, covering commercially significant European markets2, has now moved into a 210-day active assessment phase3. Telix is seeking to expand patient access to advanced brain imaging through a broad clinical label, reflective of current clinical practice guidelines4. Assuming a positive outcome from the application at Day 210, national marketing authorizations are expected to follow shortly after.
In Europe, there is currently no generally available commercial product for PET5 imaging of glioma with 18F-FET (“FET-PET”), resulting in an acute and immediate need for a consistent, high-quality product6. Through this MAA, 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. The Phase 3 IPAX-BrIGHT7 trial of TLX101-Tx in patients with recurrent glioblastoma has commenced patient dosing internationally8 and is launching in multiple European countries.
Sied Kebir, MD, Head of Clinical Neuro-Oncology, University Hospital Essen, said: “In our day-to-day practice, one of the hardest questions we face is whether a change on conventional imaging reflects tumor progression or a treatment-related effect. PET imaging with ¹⁸F-FET can be used to help resolve this dilemma. The acceptance of this application is a welcome step toward broader, standardized patient access across Europe, and more timely and accurate decision-making.”
Raphaël Ortiz, Chief Executive Officer, Telix International, commented, “The acceptance of our European MAA represents a significant regulatory milestone for Telix and for TLX101-Px. It supports a critical unmet need for widely accessible glioma imaging for both diagnostic evaluation and therapeutic decision-making. Subject to regulatory approval, we are preparing to bring this powerful precision medicine product to market in both Europe and the United States, where our new drug application has recently been accepted9.”
About glioma in Europe
In Europe, approximately 67,500 brain and central nervous system tumors are diagnosed every year10, with gliomas accounting for approximately
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 a patient selection and response assessment tool for TLX101-Tx (iodofalan 131I), Telix’s LAT1-targeting glioblastoma (GBM) therapy candidate, currently under investigation in Telix’s IPAX-213 and IPAX-BrIGHT studies. TLX101-Px and TLX101-Tx have not received marketing authorizations 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 global biopharmaceutical company focused on the development and commercialization of radiopharmaceuticals with the goal of addressing significant unmet medical need in oncology and rare diseases. 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 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 SVP Investor Relations and Corporate Communications kyahn.williamson@telixpharma.com | Telix Investor Relations (U.S.) Ms. Annie Kasparian Director Investor Relations and Corporate Communications annie.kasparian@telixpharma.com | Telix Investor Relations (Australia) Ms. Charlene Jaw Associate Director Investor Relations charlene.jaw@telixpharma.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 TLX101-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, 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 Telix ASX disclosure February 18, 2026.
2 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.
3 210-day assessment phase excludes clock-stop.
4 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.
5 Positron emission tomography.
6 Albert et al. Lancet Oncol. 2024.
7 ClinicalTrials.gov ID: NCT07100730.
8 Telix media release April 15, 2026.
9 Telix ASX disclosure April 10, 2026.
10 Frosina et al. Sci Rep. 2024.
11 Goodenberger et al. Cancer Genetics. 2012.
12 Smith et al. J Nucl Med. 2023.
13 ClinicalTrials.gov ID: NCT05450744.
