Precision Medicine Portfolio Update: Illuccix China Phase 3 Study, TLX101-CDx and TLX250-CDx FDA Resubmissions

Rhea-AI Summary

Telix (ASX: TLX, NASDAQ: TLX) provided a precision medicine portfolio update on Dec 21, 2025 covering three PET imaging candidates.

TLX591-CDx (Illuccix): Phase 3 China study (n=140) met its primary endpoint with overall patient-level PPV 94.8% (95% CI: 85.9%, 98.2%), region-level PPV 100% in prostate bed and non-bone metastases, and a 67.2% treatment-plan change rate; Telix and partner plan a near-term NDA submission in China.

TLX101-CDx (Pixclara) NDA resubmission is being finalized after collaborative FDA interactions. TLX250-CDx (Zircaix) had a Type A FDA meeting; Telix says CMC remediation alignment reached and an additional January meeting scheduled to review comparability data.

Positive

• Overall patient-level PPV of 94.8% in Illuccix China trial
• 67.2% of patients had a treatment-plan change after Illuccix imaging
• Region-level PPV 100% in prostate bed and select metastases
• TLX101 NDA resubmission is being finalized with FDA collaboration
• Agreement reached with FDA on CMC remediation path for TLX250

Negative

• TLX101 received a CRL requiring additional clinical data and analysis
• TLX250 BLA received a CRL citing CMC deficiencies needing remediation
• Additional FDA meetings and data requests will delay potential approvals

Key Figures

Illuccix China enrollment 140 patients Phase 3 registration study for TLX591-CDx in Chinese prostate cancer patients

Primary endpoint PPV 94.8% (95% CI: 85.9%, 98.2%) Patient-level positive predictive value for tumor detection with TLX591-CDx

Bone metastases PPV 87.0% Region-level PPV for bone metastases in Illuccix China Phase 3

Management changes 67.2% of patients Patients whose treatment plan changed after TLX591-CDx PSMA-PET imaging

Prostate cancer cases 134,000 men Men diagnosed with prostate cancer in China in 2022

Incidence growth 6% per year Annual increase in prostate cancer diagnoses in China

Planned PET/CT cameras 1,600 by end of 2025 Expected PET/CT installations in China vs 133 in 2010

Q2 2025 revenue US$240 million (63% YoY growth) Top-line quarterly revenue disclosed in Form 6-K dated Jul 22, 2025

Market Reality Check

$7.75 Last Close

Volume Volume 194,999 vs 20-day average 151,563 (relative volume 1.29). normal

Technical Price 7.80 is trading below the 200-day MA of 13.42 and 74.31% below the 52-week high.

Peers on Argus

While TLX traded slightly down pre-news (-0.13%), key biotech peers like RARE, APLS, LGND, MLTX and ZLAB showed positive moves today (up between 0.53% and 2.15%), suggesting TLX’s setup was stock-specific rather than sector-driven.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 10	Strategic collaboration	Positive	+3.1%	Clinical collaboration with Varian on theranostics and EBRT applications.
Nov 19	Clinical impact data	Positive	-1.5%	ZIRCON-X showed TLX250-CDx changed management in 48.6% of renal mass cases.
Nov 05	Conference participation	Neutral	+0.1%	Investor conference appearances at UBS and Jefferies healthcare events.
Oct 23	Guideline inclusion	Positive	+0.9%	TLX250-CDx added to international renal imaging guidelines citing strong ZIRCON data.
Oct 22	Trial initiation	Positive	+0.9%	First patient dosed in SOLACE Phase 1 trial for metastatic bone pain.

Pattern Detected

Recent news has generally been positive with mostly aligned price reactions; one notable divergence followed strong ZIRCON-X data.

Recent Company History

Over the last few months, Telix has reported multiple precision medicine milestones. On Oct 22, 2025 it dosed the first patient in the SOLACE trial of TLX090, and on Oct 23, 2025 TLX250-CDx was included in leading renal imaging guidelines with Phase 3 ZIRCON performance metrics. Subsequent news highlighted TLX250-CDx’s impact on clinical decision-making and a strategic theranostics collaboration with Varian. Against this backdrop, the new Illuccix China Phase 3 data and FDA interactions for TLX101-CDx and TLX250-CDx extend the same clinical and regulatory progression.

Market Pulse Summary

This announcement highlights robust Illuccix Phase 3 performance in China, with patient-level PPV of 94.8% and 67.2% of patients experiencing management changes, plus active FDA pathways for TLX101-CDx and TLX250-CDx. Recent news has emphasized clinical guideline inclusion, new trials, and strong revenue growth. Investors may focus on future NDA and BLA resubmission milestones, regional adoption in China’s growing prostate cancer market, and how Telix executes on scaling manufacturing and imaging access.

Key Terms

phase 3 medical

"positive top-line results from its Phase 3 registration study of TLX591-CDx"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

positive predictive value medical

"met its primary endpoint of patient-level positive predictive value (PPV)"

Positive predictive value is a measure of how likely it is that a positive result actually indicates a true positive. For investors, it helps assess how reliable a signal or indicator is in predicting real opportunities or risks, similar to how knowing that a weather forecast predicts rain accurately helps you decide whether to carry an umbrella. A higher positive predictive value means greater confidence that a positive signal truly reflects a meaningful event.

biochemical recurrence medical

"detection of tumors in patients with biochemical recurrence (BCR) of prostate cancer"

A biochemical recurrence is the return of signs of cancer detected by rising levels of a disease-specific blood marker after initial treatment, even when scans or symptoms are not yet obvious. For investors, it signals a likely need for additional tests, ongoing monitoring, or further treatments — creating potential demand for diagnostics, drugs, or services much like a warning light that prompts follow-up care and related spending.

psma-pet medical

"TLX591-CDx PSMA-PET imaging demonstrated high PPV in all patient groups"

A PSMA-PET scan is a medical imaging test that uses a tiny radioactive tracer that sticks to a protein commonly found on prostate cancer cells, allowing a PET scanner to highlight tumors and metastases like a GPS map for cancer. It matters to investors because it can change how accurately disease is detected and staged, influence treatment choices, and drive demand, reimbursement and sales for imaging agents, scanners and related services.

pet/ct medical

"number of PET/CT cameras installed in China is expected to surpass 1,600"

A PET/CT is a combined medical imaging test that overlays two scans—PET, which shows metabolic activity like a heat map of how tissues use energy, and CT, which shows detailed body structure like a map of roads and buildings. Investors care because PET/CT scans are widely used to diagnose and monitor diseases, guide treatment decisions, and support clinical trials, affecting demand for imaging equipment, hospital services, and diagnostic-related revenue streams.

expanded access program regulatory

"The approved Expanded Access Program (EAP)9 remains active for TLX101-CDx"

A program that allows patients with serious or life‑threatening conditions to receive an experimental drug or therapy before it is fully approved by regulators, when they cannot join clinical trials. Investors care because expanded access can change a treatment’s market perception, create early real‑world safety or demand signals, and affect regulatory timelines and potential revenue — like a pre‑order system that also reveals how the product performs outside controlled testing.

complete response letter regulatory

"review the basis of the Complete Response Letter (CRL)8"

A complete response letter is an official communication from a drug or medical-device regulator, such as the U.S. Food and Drug Administration (FDA), telling a company that a marketing application cannot be approved in its current form and listing the specific deficiencies to be fixed. For investors it matters because it pauses or delays a product’s path to market—like a building inspector issuing a list of repairs before a certificate of occupancy—affecting revenue timing, costs and stock value.

biologics license application regulatory

"review of the Biologics License Application (BLA)10 for TLX250-CDx"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

AI-generated analysis. Not financial advice.

MELBOURNE, Australia and INDIANAPOLIS, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today provides a precision medicine portfolio update in relation to:

• TLX591-CDx (Illuccix® in approved jurisdictions, ⁶⁸Ga-PSMA-11): Positive data from Phase 3 study in Chinese patients provides the basis for near-term NDA submission in China.
• TLX101-CDx (Pixclara®¹, ¹⁸F-floretyrosine), PET imaging candidate for glioma: Following collaborative interactions with the FDA, finalizing NDA resubmission and expect to provide a further near-term update on FDA acceptance of the file.
• TLX250-CDx (Zircaix®¹, ⁸⁹Zr-DFO-girentuximab), PET imaging candidate for ccRCC: Positive Type A meeting held with the FDA to align on remediation of CMC deficiencies identified in the CRL.
  

Further details on each of these updates is provided below.

Illuccix China Phase 3 Registration Study
Telix is pleased to announce positive top-line results from its Phase 3 registration study of TLX591-CDx (Illuccix®, Kit for the preparation of ⁶⁸Ga-PSMA-11) for prostate cancer imaging in Chinese patients. The Illuccix China² trial met its primary endpoint of patient-level positive predictive value (PPV) for the detection of tumors in patients with biochemical recurrence (BCR) of prostate cancer following prior radical prostatectomy or radiation therapy. The study confirms that the clinical experience of TLX591-CDx PSMA-PET³ imaging in Chinese patients is comparable to that observed in patients studied elsewhere.

Illuccix China is a Phase 3 prospective, open-label, single-arm, multicenter study conducted in collaboration with Telix’s strategic commercial partner for the Greater China region, Grand Pharmaceutical Group Limited (Grand Pharma). The study in 140 patients delivered a strong result for the primary endpoint, with an overall patient-level PPV of 94.8% for the detection of tumors with TLX591-CDx (95% confidence interval [CI]: 85.9%, 98.2%), with the lower bound of the 95% CI (85.9%). The region-level PPV was 100.0% in the prostate bed and in the extra-pelvic soft tissue, lymph nodes, and organ metastases (non-bone); 94.7% in the pelvic region outside of the prostate bed, including lymph nodes; and 87.0% in bone metastases.

In the study, patients with suspected BCR were stratified into groups according to their baseline prostate specific antigen (PSA) levels. TLX591-CDx PSMA-PET imaging demonstrated high PPV in all patient groups, including at very low baseline PSA levels.

Baseline PSA	PPV (95% CI)
≥ 5.0 ng/mL	100.0% (78.5%, 100.0%)
< 5.0 to 2.0 ng/mL	100.0% (67.6%, 100.0%)
< 2.0 to 1.0 ng/mL	90.9% (62.3%, 98.4%)
< 1.0 to 0.5 ng/mL	90.0% (59.6%, 98.2%)
< 0.5 to 0.2 ng/mL	93.3% (70.2%, 98.8%)

More than two-thirds (67.2%) of patients experienced a change in their treatment plan as a consequence of TLX591-CDx PSMA-PET imaging compared with the initial plan at baseline. This outcome confirms that PSMA-PET imaging with TLX591-CDx had a meaningful impact on clinical decision-making in Chinese patients, potentially leading to improved treatment strategies for participants with BCR. Final data from the study will be submitted for peer-reviewed publication.

Dr. David N. Cade, Group Chief Medical Officer, Telix, commented, “This is an outstanding result. The primary endpoint of the study was met decisively, with the positive predictive value significantly exceeding the performance threshold agreed with the Chinese regulator. Importantly, the high PPV was consistent even in patients with very low PSA values, and across differing metastatic locations, demonstrating broad clinical applicability. These compelling data will enable Telix and our partner Grand Pharma to submit a New Drug Application for Illuccix in China, a strategically important market.”

In China, more than 134,000 men were diagnosed with prostate cancer in 2022⁴, increasing by approximately 6% each year⁵. In line with government policy supporting wider geographic access to nuclear medicine, the number of PET/CT cameras installed in China is expected to surpass 1,600 by the end of 2025⁶, compared with 133 in 2010⁷.

FDA Resubmission Update: TLX101-CDx
Telix advises that its New Drug Application (NDA) resubmission for TLX101-CDx, (Pixclara®¹, ¹⁸F-floretyrosine) to the United States (U.S.) Food and Drug Administration (FDA), is progressing well. The Company has had collaborative interactions with the FDA around providing additional clinical data and a revised statistical analysis plan.

Following a productive Type A meeting to review the basis of the Complete Response Letter (CRL)⁸, Telix is currently finalizing its package for resubmission. The Company will provide a further near-term update when the resubmission has been filed and accepted by the FDA. The approved Expanded Access Program (EAP)⁹ remains active for TLX101-CDx, reflective of Telix’s commitment to serving patients.

FDA Resubmission Update: TLX250-CDx
Telix has recently participated in a Type A meeting to discuss the CRL it received following review of the Biologics License Application (BLA)¹⁰ for TLX250-CDx (Zircaix®¹, ⁸⁹Zr-DFO-girentuximab). Telix believes it has reached alignment with the FDA on the remediation of identified deficiencies regarding the product’s chemistry, manufacturing, and controls (CMC) package, which formed the substantive basis of the CRL.

The FDA has collaboratively granted Telix an additional meeting in January to review Telix’s plan for the additional data requested to establish comparability between the drug product used in the ZIRCON Phase 3 clinical trial¹¹ and the scaled-up manufacturing process intended for commercial use. Telix will provide a further update following receipt of the official FDA meeting minutes of both Type A meetings. The approved Expanded Access Program (EAP)¹² remains active for TLX250-CDx, reflective of Telix’s commitment to serving patients.

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).

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. FDA¹³.

TLX101-CDx is Telix’s PET imaging candidate for glioma, a rare and life-threatening brain cancer. TLX250-CDx is Telix’s PET imaging candidate for the diagnosis and characterization of clear cell renal cell carcinoma, the most common kidney cancer subtype. TLX101-CDx and TLX250-CDx have not received a marketing authorization 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
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com

Telix Investor Relations (U.S.)

Annie Kasparian
Telix Pharmaceuticals Limited
Director Investor Relations and Corporate Communications
Email: annie.kasparian@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-CDx and the planned BLA resubmission for TLX250-CDx, 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.

©2025 Telix Pharmaceuticals Limited. All rights reserved.

____________________________
¹ Brand name subject to final regulatory approval.
² ClinicalTrials.gov ID: NCT05847348.
³ Imaging of prostate-specific membrane antigen with positron emission tomography.
⁴ Global Cancer Statistics 2022: GLOBOCAN survey. Published August 2024.
⁵ Ye Dingwei et al. Lancet Oncology, 2022.
⁶ Yang et al. J Nuc. Med. 2024.
⁷ Goetz Partners research 2020.
⁸ Telix ASX disclosure 28 April 2025.
⁹ ClinicalTrials.gov ID: NCT06743100.
¹⁰ Telix ASX disclosure 28 August 2025.
¹¹ ClinicalTrials.gov ID: NCT03849118.
¹² ClinicalTrials.gov ID: NCT06090331.
¹³ Telix ASX disclosure 21 March 2025.

FAQ

What did Telix announce about Illuccix (TLX591-CDx) on Dec 21, 2025?

The Phase 3 China study (n=140) met its primary endpoint with overall patient-level PPV 94.8% and a 67.2% treatment-plan change rate, supporting a near-term NDA submission in China.

How effective was Illuccix (TLX591-CDx) across metastatic sites in the China trial?

Region-level PPV was 100% in the prostate bed and non-bone metastases, 94.7% in pelvic region, and 87.0% in bone metastases.

What is the status of the TLX101-CDx (Pixclara) NDA with the FDA for TLX?

Telix is finalizing an NDA resubmission after collaborative FDA interactions and will provide a near-term update when the resubmission is filed and accepted.

What did Telix report about TLX250-CDx (Zircaix) and FDA interactions?

Telix held a Type A meeting, says it reached alignment on CMC remediation, and has an additional January meeting to review comparability data requested by the FDA.

Will Telix submit Illuccix for regulatory approval in China soon (TLX)?

Yes; Telix and partner Grand Pharma plan a near-term New Drug Application submission for Illuccix in China based on the positive Phase 3 results.

How did Illuccix imaging affect patient management in the China study?

Imaging led to a change in the planned treatment for 67.2% of patients compared with baseline plans.