Telix Resubmits NDA to U.S. FDA for TLX101-Px (Pixclara®) Brain Cancer Imaging Candidate
Rhea-AI Summary
Telix (ASX: TLX, NASDAQ: TLX) resubmitted a New Drug Application to the U.S. FDA for TLX101-Px (Pixclara®, 18F-FET) to image recurrent or progressive glioma in adults and pediatric patients.
The resubmission includes additional data and statistical analysis requested after a prior Complete Response Letter. TLX101-Px holds Orphan Drug and Fast Track designations and addresses an unmet need for targeted amino acid PET imaging in the U.S.
Positive
- NDA resubmission includes requested additional data and statistical analysis
- TLX101-Px granted Orphan Drug designation by FDA
- TLX101-Px granted Fast Track designation by FDA
- Potential to be first FDA-approved targeted amino acid PET agent for brain cancer imaging in U.S.
Negative
- Company previously received a Complete Response Letter requiring additional data
- Approval remains uncertain pending FDA review of resubmitted data
News Market Reaction – TLX
On the day this news was published, TLX declined 0.25%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Market Reality Check
Peers on Argus
TLX slipped -0.51% while peers were mixed: RARE -2.73%, LGND -4.05%, ZLAB -2.55%, APLS +0.53%, MLTX -0.06%. No clear sector-wide pattern.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 09 | Phase 3 update | Positive | +5.5% | ProstACT Global Phase 3 Part 1 met safety and dosimetry objectives. |
| Mar 01 | Investor outreach | Neutral | -2.8% | Announcement of investor education webinar on prostate imaging. |
| Feb 27 | AI collaboration | Neutral | -3.6% | AI-enabled PSMA-PET research collaboration with University Hospital Essen. |
| Feb 20 | Conference participation | Positive | +14.6% | Planned participation in Oppenheimer and TD Cowen investor conferences. |
| Feb 19 | Earnings results | Positive | +14.6% | FY 2025 results with strong revenue growth and FY 2026 guidance. |
Recent substantive clinical and financial updates (Phase 3 progress, FY 2025 results) have coincided with strong positive moves, while informational items show mixed reactions.
Over recent months Telix has reported multiple milestones. FY 2025 results showed revenue of US$803.8M with strong year-over-year growth and FY 2026 revenue guidance of US$950–970M. A Phase 3 ProstACT study update on Mar 09 2026 confirmed primary objectives and acceptable safety, and an earlier FY 2025 results release and conference participation around Feb 19–20 2026 both saw notable positive price reactions. The current NDA resubmission adds another regulatory step to this trajectory.
Market Pulse Summary
This announcement details Telix’s resubmission of an NDA to the U.S. FDA for TLX101-Px, an investigational PET imaging agent for recurrent or progressive glioma, backed by additional data requested in a prior Complete Response Letter and supported by Orphan Drug and Fast Track designations. In context of recent Phase 3 progress and strong FY 2025 revenue of US$803.8M, investors may track FDA feedback, review timelines, and how this candidate complements Telix’s broader radiopharmaceutical portfolio.
Key Terms
new drug application regulatory
nda regulatory
food and drug administration regulatory
fda regulatory
pet imaging medical
glioma medical
orphan drug regulatory
fast track regulatory
AI-generated analysis. Not financial advice.
MELBOURNE, Australia and INDIANAPOLIS, March 16, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces the resubmission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX101-Px, (Pixclara®1, Floretyrosine F 18 or 18F-FET), an investigational PET2 imaging agent for the characterization of recurrent or progressive glioma (brain cancer) from treatment related changes in both adult and pediatric patients.
Telix has resubmitted the NDA with the additional data requested by the FDA. The Company believes, based on the Type A meeting and ongoing consultation with the FDA, that the additional data and statistical analysis, along with the primary data set provided in the original submission, appropriately addresses the Complete Response Letter3.
Given the potential to address significant unmet medical need, TLX101-Px has been granted Orphan Drug4 and Fast Track5 designations by the FDA. PET imaging with 18F-FET is already included in international clinical practice guidelines for the imaging of gliomas6, however there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging commercially available in the U.S.
Dr. David N. Cade, Telix Group Chief Medical Officer, said, “We appreciate the FDA’s recognition of the critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting. Our resubmission is supported by an extensive and compelling data set – particularly so for an orphan indication. We are grateful to our global clinical collaborators, who share our commitment to ensuring patients in the U.S. can benefit from this important patient management tool.”
Maggie Haynes, Executive Director, Head for the Cure Foundation, added: “Our community is encouraged by the FDA’s ongoing engagement and guidance to the sponsor and support for the Expanded Access Program for TLX101-Px. We are hopeful of an expedited review, so this important and proven imaging option can become available to those who urgently need it.”
About TLX101-Px
TLX101-Px is a PET imaging agent, which has been granted fast track and orphan drug designations by the FDA as an imaging agent for the characterization of recurrent or progressive glioma from treatment related changes. TLX101-Px targets membrane transport proteins known as LAT1 and LAT27. This enables TLX101-Px to be potentially utilized as a companion diagnostic agent to TLX101-Tx (iodofalan 131I), Telix’s LAT1-targeting glioblastoma (GBM) therapy candidate, currently under investigation in the pivotal IPAX-BrIGHT study8.
About gliomas in the U.S.
Gliomas are very diffusely infiltrative tumors that affect the surrounding brain tissue. They are the most common form of central nervous system (CNS) neoplasm that originates from glial cells, accounting for approximately
About Telix Pharmaceuticals Limited
Telix is a global biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies, with the goal to address significant unmet medical needs in oncology and rare diseases. With international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland), and Japan, Telix is headquartered in Melbourne, Australia. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).
Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s first generation PSMA-PET imaging agent, has been approved in multiple markets globally. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA14. TLX101-Px and TLX101-Tx have not received marketing authorizations in any jurisdiction.
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.
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 Brand name subject to final regulatory approval.
2 Positron emission tomography.
3 Telix ASX disclosure April 28, 2025.
4 Telix ASX disclosure October 6, 2020.
5 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
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 L-type amino acid transporters 1 and 2.
8 ClinicalTrials.gov ID: NCT07100730.
9 Goodenberger et al. Cancer Genet. 2012.
10 Mesfin et al. StatPearls. 2024.
11 Ostrom 2022, CBTRUS (Central Brain Tumor Registry of the United States) Statistical Report.
12 Park et al. Journal of Clinical Oncology. 2010.
13 Ostrom et al. Neuro Oncol. 2018.
14 Telix ASX disclosure March 21, 2025.
