 |
MELBOURNE, Australia and INDIANAPOLIS, Dec. 22, 2025 /PRNewswire/ — Telix Prescribed drugs Restricted (ASX: TLX, NASDAQ: TLX, “Telix”) at present offers a precision drugs portfolio replace in relation to:
- TLX591-CDx (Illuccix® in permitted jurisdictions, 68Ga-PSMA-11): Optimistic information from Section 3 research in Chinese language sufferers offers the premise 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 anticipate to offer an extra near-term replace on FDA acceptance of the file.
- TLX250-CDx (Zircaix®[1], 89Zr-DFO-girentuximab), PET imaging candidate for ccRCC: Optimistic Sort A gathering held with the FDA to align on remediation of CMC deficiencies recognized within the CRL.
Additional particulars on every of those updates is offered beneath.
Illuccix China Section 3 Registration Research
Telix is happy to announce constructive top-line outcomes from its Section 3 registration research of TLX591-CDx (Illuccix®, Package for the preparation of 68Ga-PSMA-11) for prostate most cancers imaging in Chinese language sufferers. The Illuccix China[2] trial met its major endpoint of patient-level constructive predictive worth (PPV) for the detection of tumors in sufferers with biochemical recurrence (BCR) of prostate most cancers following prior radical prostatectomy or radiation remedy. The research confirms that the scientific expertise of TLX591-CDx PSMA-PET[3] imaging in Chinese language sufferers is similar to that noticed in sufferers studied elsewhere.
Illuccix China is a Section 3 potential, open-label, single-arm, multicenter research performed in collaboration with Telix’s strategic business companion for the Better China area, Grand Pharmaceutical Group Restricted (Grand Pharma). The research in 140 sufferers delivered a robust end result for the first endpoint, with an total patient-level PPV of 94.8% for the detection of tumors with TLX591-CDx (95% confidence interval [CI]: 85.9%, 98.2%), with the decrease sure of the 95% CI (85.9%). The region-level PPV was 100.0% within the prostate mattress and within the extra-pelvic comfortable tissue, lymph nodes, and organ metastases (non-bone); 94.7% within the pelvic area exterior of the prostate mattress, together with lymph nodes; and 87.0% in bone metastases.
Within the research, sufferers with suspected BCR have been stratified into teams in response to their baseline prostate particular antigen (PSA) ranges. TLX591-CDx PSMA-PET imaging demonstrated excessive PPV in all affected person teams, together with at very low baseline PSA ranges.
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%) |
Greater than two-thirds (67.2%) of sufferers skilled a change of their therapy plan as a consequence of TLX591-CDx PSMA-PET imaging in contrast with the preliminary plan at baseline. This end result confirms that PSMA-PET imaging with TLX591-CDx had a significant impression on scientific decision-making in Chinese language sufferers, doubtlessly resulting in improved therapy methods for contributors with BCR. Last information from the research might be submitted for peer-reviewed publication.
Dr. David N. Cade, Group Chief Medical Officer, Telix, commented, “That is an excellent end result. The first endpoint of the research was met decisively, with the constructive predictive worth considerably exceeding the efficiency threshold agreed with the Chinese language regulator. Importantly, the excessive PPV was constant even in sufferers with very low PSA values, and throughout differing metastatic areas, demonstrating broad scientific applicability. These compelling information will allow Telix and our companion Grand Pharma to submit a New Drug Utility for Illuccix in China, a strategically essential market.”
In China, greater than 134,000 males have been recognized with prostate most cancers in 2022[4], growing by roughly 6% every year[5]. According to authorities coverage supporting wider geographic entry to nuclear drugs, the variety of PET/CT cameras put in in China is predicted to surpass 1,600 by the top of 2025[6], in contrast with 133 in 2010[7].
FDA Resubmission Replace: TLX101-CDx
Telix advises that its New Drug Utility (NDA) resubmission for TLX101-CDx, (Pixclara®[1], 18F-floretyrosine) to the USA (U.S.) Meals and Drug Administration (FDA), is progressing effectively. The Firm has had collaborative interactions with the FDA round offering further scientific information and a revised statistical evaluation plan.
Following a productive Sort A gathering to assessment the premise of the Full Response Letter (CRL)[8], Telix is presently finalizing its package deal for resubmission. The Firm will present an extra near-term replace when the resubmission has been filed and accepted by the FDA. The permitted Expanded Entry Program (EAP)[9] stays lively for TLX101-CDx, reflective of Telix’s dedication to serving sufferers.
FDA Resubmission Replace: TLX250-CDx
Telix has lately participated in a Sort A gathering to debate the CRL it obtained following assessment of the Biologics License Utility (BLA)[10] for TLX250-CDx (Zircaix®[1], 89Zr-DFO-girentuximab). Telix believes it has reached alignment with the FDA on the remediation of recognized deficiencies relating to the product’s chemistry, manufacturing, and controls (CMC) package deal, which fashioned the substantive foundation of the CRL.
The FDA has collaboratively granted Telix a further assembly in January to assessment Telix’s plan for the extra information requested to determine comparability between the drug product used within the ZIRCON Section 3 scientific trial[11] and the scaled-up manufacturing course of supposed for business use. Telix will present an extra replace following receipt of the official FDA assembly minutes of each Sort A conferences. The permitted Expanded Entry Program (EAP)[12] stays lively for TLX250-CDx, reflective of Telix’s dedication to serving sufferers.
About Telix Prescribed drugs Restricted
Telix is a biopharmaceutical firm targeted on the event and commercialization of therapeutic and diagnostic radiopharmaceuticals and related medical applied sciences. Telix is headquartered in Melbourne, Australia, with worldwide operations in the USA, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is growing a portfolio of scientific and business stage merchandise that goals to deal with important unmet medical wants in oncology and uncommon ailments. Telix is listed on the Australian Securities Alternate (ASX: TLX) and the Nasdaq International Choose Market (NASDAQ: TLX).
Illuccix® (package for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s first technology PSMA-PET imaging agent, has been permitted in a number of markets globally. Gozellix® (package for the preparation of gallium-68 (68Ga) gozetotide injection) has been permitted by the U.S. FDA[13].
TLX101-CDx is Telix’s PET imaging candidate for glioma, a uncommon and life-threatening mind most cancers. TLX250-CDx is Telix’s PET imaging candidate for the analysis and characterization of clear cell renal cell carcinoma, the commonest kidney most cancers subtype. TLX101-CDx and TLX250-CDx haven’t obtained a advertising authorization in any jurisdiction.
Go to www.telixpharma.com for additional details about Telix, together with particulars of the newest share worth, ASX and U.S. Securities and Alternate Fee (SEC) filings, investor and analyst shows, information releases, occasion particulars and different publications that could be of curiosity. You can even comply with Telix on LinkedIn, X and Fb
Telix Investor Relations (International)
Ms. Kyahn Williamson
Telix Prescribed drugs Restricted
SVP Investor Relations and Company Communications
Electronic mail: kyahn.williamson@telixpharma.com
Telix Investor Relations (U.S.)
Annie Kasparian
Telix Prescribed drugs Restricted
Director Investor Relations and Company Communications
Electronic mail: annie.kasparian@telixpharma.com
Media Contact
Eliza Schleifstein
917.763.8106 (Cell)
Eliza@schleifsteinpr.com
This announcement has been approved for launch by the Telix Prescribed drugs Restricted Disclosure Committee on behalf of the Board.
Authorized Notices
Cautionary Assertion Concerning Ahead-Wanting Statements.
It is best to learn this announcement along with our threat elements, as disclosed in our most lately filed reviews with the Australian Securities Alternate (ASX), U.S. Securities and Alternate Fee (SEC), together with our Annual Report on Kind 20-F filed with the SEC, or on our web site.
The data contained on this announcement will not be supposed to be a proposal for subscription, invitation or suggestion with respect to securities of Telix Prescribed drugs Restricted (Telix) in any jurisdiction, together with the USA. The data and opinions contained on this announcement are topic to vary with out notification. To the utmost extent permitted by regulation, Telix disclaims any obligation or endeavor to replace or revise any info or opinions contained on this announcement, together with any forward-looking statements (as referred to beneath), whether or not on account of new info, future developments, a change in expectations or assumptions, or in any other case. No illustration or guarantee, categorical or implied, is made in relation to the accuracy or completeness of the data contained or opinions expressed in the middle of this announcement.
This announcement could include forward-looking statements, together with throughout the that means of the U.S. Personal Securities Litigation Reform Act of 1995, that relate to anticipated future occasions, monetary efficiency, plans, methods or enterprise developments. Ahead-looking statements can usually be recognized by way of phrases comparable to “could”, “anticipate”, “intend”, “plan”, “estimate”, “anticipate”, “imagine”, “outlook”, “forecast” and “steerage”, or the detrimental of those phrases or different comparable phrases or expressions. Ahead-looking statements contain recognized and unknown dangers, uncertainties and different elements which will trigger our precise outcomes, ranges of exercise, efficiency or achievements to vary materially from any future outcomes, ranges of exercise, efficiency or achievements expressed or implied by these forward-looking statements. Ahead-looking statements are based mostly on Telix’s good-faith assumptions as to the monetary, market, regulatory and different dangers and issues that exist and have an effect on Telix’s enterprise and operations sooner or later and there might be no assurance that any of the assumptions will show to be appropriate. Within the context of Telix’s enterprise, forward-looking statements could embody, however are usually not restricted to, statements about: the initiation, timing, progress, completion and outcomes of Telix’s preclinical and scientific trials, and Telix’s analysis and growth applications; Telix’s potential to advance product candidates into, enroll and efficiently full, scientific research, together with multi-national scientific trials; the timing or probability of regulatory filings and approvals for Telix’s product candidates, together with the deliberate NDA resubmission for TLX101-CDx and the deliberate BLA resubmission for TLX250-CDx, manufacturing actions and product advertising actions; Telix’s gross sales, advertising and distribution and manufacturing capabilities and techniques; the commercialization of Telix’s product candidates, if or after they have been permitted; Telix’s potential to acquire an sufficient provide of uncooked supplies at affordable prices for its merchandise and product candidates; estimates of Telix’s bills, future revenues and capital necessities; Telix’s monetary efficiency; developments regarding Telix’s rivals and trade; the anticipated impression of U.S. and international tariffs and different macroeconomic situations on Telix’s enterprise; and the pricing and reimbursement of Telix’s product candidates, if and after they’ve been permitted. Telix’s precise outcomes, efficiency or achievements could also be materially totally different from these which can be expressed or implied by such statements, and the variations could also be opposed. Accordingly, you shouldn’t place undue reliance on these forward-looking statements.
Emblems and Commerce Names. All logos and commerce names referenced on this press launch are the property of Telix Prescribed drugs Restricted (Telix) or, the place relevant, the property of their respective house owners. For comfort, logos and commerce names could seem with out the ® or ™ symbols. Such omissions are usually not supposed to point any waiver of rights by Telix or the respective house owners. Trademark registration standing could differ from nation to nation. Telix doesn’t intend the use or show of any third-party logos or commerce names to indicate any affiliation with, endorsement by, or sponsorship from these third events.
©2025 Telix Prescribed drugs Restricted. All rights reserved.
[1] Model title topic to closing regulatory approval. |
[2] ClinicalTrials.gov ID: NCT05847348. |
[3] Imaging of prostate-specific membrane antigen with positron emission tomography. |
[4] International Most cancers Statistics 2022: GLOBOCAN survey. Revealed August 2024. |
[5] Ye Dingwei et al. Lancet Oncology, 2022. |
[6] Yang et al. J Nuc. Med. 2024. |
[7] Goetz Companions analysis 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. |
