FDA accepts Telix (TLX) TLX101-Px NDA, sets Sept 2026 PDUFA date
Filing Impact
Filing Sentiment
Form Type
6-K
Rhea-AI Filing Summary
Telix Pharmaceuticals reports that the U.S. FDA has accepted its resubmitted New Drug Application for TLX101-Px (Pixclara), a PET imaging agent for glioma, and has assigned a PDUFA goal date of September 11, 2026.
TLX101-Px has Orphan Drug and Fast Track designations and is intended to help distinguish recurrent or progressive glioma from treatment-related changes in adults and children. Telix notes that its FY 2026 financial guidance does not include any revenue from TLX101-Px.
Positive
- FDA acceptance of TLX101-Px NDA with a PDUFA goal date of September 11, 2026 establishes a clear regulatory path for Telix’s glioma imaging agent.
- Orphan Drug and Fast Track designations for TLX101-Px highlight recognition of significant unmet medical need in recurrent or progressive glioma imaging.
- Potential synergy with TLX101-Tx, as TLX101-Px may be used for patient selection and response assessment in Telix’s LAT1-targeting therapy program.
Negative
- None.
Insights
FDA acceptance of Telix’s TLX101-Px NDA sets a clear review timeline for a key glioma imaging asset.
The FDA has accepted the New Drug Application for TLX101-Px (Pixclara), a PET imaging agent using 18F-FET to characterize recurrent or progressive glioma. Acceptance and assignment of a PDUFA goal date of September 11, 2026 confirm the filing is complete and under formal review.
TLX101-Px holds Orphan Drug and Fast Track designations, reflecting the serious nature of glioma and unmet need in distinguishing tumor progression from treatment-related changes. The agent is also positioned as a potential patient selection and response tool for Telix’s LAT1-targeting therapy candidate TLX101-Tx.
Importantly, Telix states that FY 2026 financial guidance excludes revenue from TLX101-Px, signaling that any potential approval and launch would represent upside to current expectations. Actual commercial impact will depend on regulatory outcome and adoption once the FDA review, targeted by the PDUFA date, is completed.
Key Figures
PDUFA goal date: September 11, 2026
FDA designations: Orphan Drug and Fast Track
Guidance treatment of TLX101-Px revenue: Excluded from FY 2026 guidance
+4 more
7 metrics
PDUFA goal date
September 11, 2026
FDA review timeline for TLX101-Px NDA
FDA designations
Orphan Drug and Fast Track
For TLX101-Px in recurrent or progressive glioma
Guidance treatment of TLX101-Px revenue
Excluded from FY 2026 guidance
No TLX101-Px revenue assumed in FY 2026
Annual new glioma cases (U.S.)
Approximately 24,000 cases
Incidence of glioma in the United States
Share of brain and CNS tumors
30% of all brain and CNS tumors
Gliomas’ proportion of primary brain/CNS tumors
Share of malignant brain tumors
80% of malignant brain tumors
Gliomas among malignant brain cancers
Glioblastoma survival duration
12–15 months from diagnosis
Expected survival despite standard treatment
Key Terms
New Drug Application, PDUFA goal date, Orphan Drug, Fast Track, +2 more
6 terms
New Drug Application regulatory
"FDA has accepted the Company’s resubmitted New Drug Application (NDA) for TLX101-Px"
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.
PDUFA goal date regulatory
"and has assigned a PDUFA goal date of September 11, 2026"
The PDUFA goal date is the target deadline set by the U.S. Food and Drug Administration for completing its review of a new drug or biologic application. Investors watch it like a court date for a product: the outcome (approval, rejection, or request for more information) can sharply change a company’s revenue prospects and stock price, and the date gives a predictable event around which markets and planning can focus.
Orphan Drug regulatory
"TLX101-Px has been granted Orphan Drug and Fast Track designations by the FDA"
A drug designated for an orphan disease is a medicine developed to treat a rare condition that affects only a small number of people. Regulators often give these drugs special incentives—such as reduced costs, faster review, and temporary exclusive selling rights—to encourage development, which matters to investors because those incentives can make a small market financially viable and reduce competition, much like a temporary patent on a niche product.
Fast Track regulatory
"Fast Track is a process designed to facilitate the development, and expedite the review of drugs"
A fast track designation is a regulatory label that speeds up the review and communication between a drug developer and regulators for treatments addressing serious illnesses or unmet medical needs. For investors, it matters because it can shorten development time and reduce regulatory delays—like getting a VIP lane at the airport—raising the chance of earlier market access and potential revenue, though it does not guarantee approval.
glioblastoma medical
"Glioblastoma (GBM) is a high-grade glioma and the most common and aggressive form"
Glioblastoma is a fast-growing and aggressive type of brain tumor that can affect a person's thinking, movement, or senses. Its seriousness and difficulty to treat can lead to significant health impacts, making it a concern for medical research and drug development. For investors, advances or setbacks in glioblastoma treatments can influence biotech companies and healthcare markets focused on cancer therapies.
positron emission tomography technical
"TLX101-Px is a PET imaging candidate, Positron emission tomography"
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.
Telix Pharmaceuticals Limited ACN 616 620 369 55 Flemington Road North Melbourne Victoria, 3051 Australia ASX ANNOUNCEMENT Page 1 FDA Accepts NDA for TLX101-Px (Pixclara®) Melbourne (Australia) and Indianapolis, IN (U.S.) – April 10, 2026. Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Company’s resubmitted New Drug Application (NDA) for TLX101-Px1, (Pixclara®2, Floretyrosine F 18 or 18F-FET), an investigational PET3 agent for the imaging of glioma (brain cancer), and has assigned a PDUFA4 goal date of September 11, 2026. The approval of TLX101-Px will fulfil a significant unmet medical need for the characterization of recurrent or progressive glioma from treatment related changes in both adult and pediatric patients5. Neuroimaging of glioma with 18F-FET is already broadly recommended in international clinical practice guidelines – including NCCN Guidelines®6 – and TLX101-Px has been granted Orphan Drug7 and Fast Track8 designations by the FDA. “There remains a critical unmet need in improving our ability to image residual glioma after treatment,” said Thomas Hope, MD, Vice Chair, Department of Radiology and Biomedical Imaging, University of California, San Francisco (UCSF). “We have worked with Telix for the last three years to help leverage our clinical data to help make FET-PET9 available to patients in the United States.” Patrick Wen, MD, E. Antonio Chiocca, MD, PhD, Family Endowed Chair in Neuro-Oncology at Mass General Brigham Cancer Institute, added, “Distinguishing tumor progression from treatment-related change remains one of the most challenging aspects of glioma care. PET imaging with 18F-FET is an important tool in clinical practice worldwide, and the FDA’s acceptance of this application is a meaningful step toward broader access for patients and clinicians in the United States.” Kevin Richardson, CEO, Telix Precision Medicine, added, “The FDA’s acceptance of our NDA resubmission is an important milestone for Telix. We appreciate the FDA’s constructive engagement and look forward to working closely with the Agency to urgently obtain approval and then bring this product to market for the benefit of patients.” Telix’s FY 2026 financial guidance does not include any revenue contribution from TLX101-Px. About TLX101-Px TLX101-Px is a PET imaging candidate, which has been granted Fast Track and Orphan Drug designations by the FDA for the characterization of recurrent or progressive glioma from treatment related changes. TLX101-Px targets membrane transport proteins known as L-type amino acid 1 Telix’s NDA was resubmitted on March 13, 2026. Telix ASX disclosure March 16, 2026. 2 Brand name subject to final regulatory approval. 3 Positron emission tomography. 4 Prescription Drug User Fee Act. 5 Subject to FDA review and approval. 6 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. 7 Telix ASX disclosure October 6, 2020. 8 Telix ASX disclosure April 16, 2024. 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. The purpose is to get important new drugs to the patient earlier. More: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority- review/fast-track 9 Positron emission tomography imaging with Floretyrosine F 18.
Page 2 transporters 1 and 2 (LAT1 and LAT2). This enables TLX101-Px to be potentially utilized as a patient selection and response assessment tool for Telix’s LAT1-targeting therapy candidate TLX101-Tx (iodofalan 131I), currently under investigation in the pivotal IPAX-BrIGHT trial in patients with recurrent glioblastoma10 . TLX101-Px and TLX101-Tx have not received marketing authorizations in any jurisdiction. About gliomas Gliomas are diffusely infiltrative tumors that affect the surrounding brain tissue. They are the most common form of central nervous system (CNS) cancer that originates from glial cells, accounting for approximately 30% of all brain and CNS tumors and 80% of all malignant brain tumors11. In the U.S., there are approximately 24,000 new glioma cases diagnosed annually12. Glioblastoma (GBM) is a high-grade glioma and the most common and aggressive form of primary brain cancer. The mainstay of treatment for GBM comprises surgical resection, followed by combined radiotherapy and chemotherapy. Despite such treatment, recurrence occurs in almost all patients13, with an expected survival duration of 12-15 months from diagnosis14. 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 Media Contact Eliza Schleifstein 917.763.8106 (Mobile) Eliza@schleifsteinpr.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. 10 ClinicalTrials.gov ID: NCT07100730. 11 Goodenberger et al. Cancer Genet. 2012. 12 CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2018-2022. Neuro-Oncology. 2025. 13 Park et al. Journal of Clinical Oncology. 2010. 14 Ostrom et al. Neuro Oncol. 2018.
Page 3 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 and 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, 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.
FAQ
What did the FDA decide about Telix (TLX) drug TLX101-Px?
The FDA accepted Telix’s resubmitted New Drug Application for TLX101-Px (Pixclara), a PET imaging agent for glioma, and set a PDUFA goal date of September 11, 2026. This means the application is filed and under formal regulatory review.
What is TLX101-Px (Pixclara) and what condition is it targeting for Telix (TLX)?
TLX101-Px is an investigational PET imaging agent using 18F-FET that targets LAT1 and LAT2 transporters. It is intended to help characterize recurrent or progressive glioma versus treatment-related changes in both adult and pediatric patients, addressing a major diagnostic challenge in brain cancer care.
What special FDA designations has Telix (TLX) received for TLX101-Px?
TLX101-Px has been granted Orphan Drug and Fast Track designations by the FDA. Orphan status recognizes its use in a rare disease, while Fast Track is designed to facilitate development and expedite review for serious conditions with unmet medical need.
How does TLX101-Px relate to Telix (TLX) therapy candidate TLX101-Tx?
TLX101-Px targets LAT1 and LAT2 transporters, allowing potential use as a patient selection and response assessment tool for Telix’s LAT1-targeting therapy candidate TLX101-Tx (iodofalan 131I), which is being investigated in the pivotal IPAX-BrIGHT trial in recurrent glioblastoma.
Does Telix (TLX) include TLX101-Px revenue in its FY 2026 financial guidance?
No. Telix explicitly states that its FY 2026 financial guidance does not include any revenue contribution from TLX101-Px. This indicates that potential revenue from approval or commercialization would be incremental to the company’s current guidance assumptions.
How common are gliomas, the cancer targeted by Telix (TLX) imaging agent TLX101-Px?
Gliomas are the most common primary central nervous system cancers, representing about 30% of all brain and CNS tumors and 80% of malignant brain tumors. In the United States, approximately 24,000 new glioma cases are diagnosed each year, underscoring the clinical need.