{"id":96210,"date":"2025-07-09T23:26:08","date_gmt":"2025-07-09T23:26:08","guid":{"rendered":"https:\/\/pakistaninewspaperlist.com\/news\/gozellix-receives-permanent-hcpcs-code\/"},"modified":"2025-07-09T23:26:08","modified_gmt":"2025-07-09T23:26:08","slug":"gozellix-receives-permanent-hcpcs-code","status":"publish","type":"post","link":"https:\/\/pakistaninewspaperlist.com\/news\/gozellix-receives-permanent-hcpcs-code\/","title":{"rendered":"Gozellix Receives Permanent HCPCS Code"},"content":{"rendered":"
\n

MELBOURNE, Australia and INDIANAPOLIS, July 10, 2025 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, \u201cTelix\u201d) today announces that its next-generation PSMA1<\/sup> PET2<\/sup> imaging agent, Gozellix\u00ae (kit for the preparation of gallium-68 (68<\/sup>Ga) gozetotide injection), has been granted a permanent Healthcare Common Procedure Coding System (HCPCS) code by the U.S. Centers for Medicare & Medicaid Services (CMS).<\/p>\n

Effective from 1 October 2025, CMS and commercial health insurers will recognise the HCPCS Level II code A9616 assigned for reimbursement of Gozellix. The assignment of the code is a significant milestone supporting provider billing and reimbursement for Gozellix, and a further step toward receiving\u00a0Transitional Pass-Through (TPT) payment status.<\/p>\n

After radiolabelling with 68<\/sup>Ga, Gozellix is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected biochemical recurrence (BCR) based on elevated serum prostate-specific antigen (PSA) level.3<\/sup> With its\u00a0extended shelf-life and flexible production options, Gozellix overcomes many of the logistical barriers that have historically limited access to PSMA-PET imaging. Telix believes receiving a HCPCS code will support clinical adoption of Gozellix and expanded access to PSMA PET imaging.<\/p>\n

Kevin Richardson, Chief Executive Officer, Precision Medicine, Telix, said, \u201cBeing granted a HCPCS code marks a significant step forward in Telix\u2019s mission to improve access to precision medicine imaging for prostate cancer patients across the United States, regardless of their location. It is also an important enabler for commercial scale-up and reimbursement of Gozellix in the U.S. as we bring our next-generation PSMA PET imaging agent to market.\u201d<\/p>\n

About <\/strong>Telix Pharmaceuticals Limited <\/strong><\/p>\n

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, 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).<\/p>\n

Illuccix\u00ae (kit for the preparation of gallium-68 (68<\/sup>Ga) gozetotide injection), Telix\u2019s first generation PSMA-PET imaging agent, has been approved in multiple markets globally. Gozellix\u00ae (kit for the preparation of gallium-68 (68<\/sup>Ga) gozetotide injection) has been approved by the U.S. FDA4<\/sup>.<\/p>\n

Visit www.telixpharma.com<\/a> for further information about Telix, including details of the latest share price, ASX and 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<\/a>, X<\/a> and Facebook<\/a>.<\/p>\n

Telix Investor Relations<\/strong>
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com<\/a><\/p>\n

Telix Investor Relations (U.S.)<\/strong>
Annie Kasparian
Telix Pharmaceuticals Limited
Director Investor Relations and Corporate Communications
Email: annie.kasparian@telixpharma.com<\/a><\/p>\n

Media Contact<\/strong>
Eliza Schleifstein
917.763.8106 (Mobile)
Eliza@schleifsteinpr.com<\/a><\/p>\n

IMPORTANT SAFETY INFORMATION<\/strong>
WARNINGS AND PRECAUTIONS<\/strong><\/p>\n

Risk for Misinterpretation<\/u>
Image interpretation errors can occur with Gozellix PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga-68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget\u2019s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.<\/p>\n

Imaging Prior to Initial Definitive or Suspected Recurrence Therapy<\/u>
The performance of Gozellix for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of Gozellix for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.<\/p>\n

Radiation Risks<\/u>
Gallium Ga-68 gozetotide contributes to a patient\u2019s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.<\/p>\n

Hypersensitivity Reactions <\/u>
Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.<\/p>\n

ADVERSE REACTIONS<\/strong>
The safety of gallium Ga-68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMABCR studies, each receiving one dose of gallium Ga-68 gozetotide. The average injected activity was 188.7 \u00b1 40.7 MBq (5.1 \u00b1 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.<\/p>\n

DRUG INTERACTIONS<\/strong>
Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga-68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga-68 gozetotide PET has not been established.<\/p>\n

Please note that this information summary is not comprehensive.<\/strong><\/p>\n

Please see the Full Prescribing Information <\/strong>here<\/strong><\/a>.<\/strong><\/p>\n

You are encouraged to report suspected adverse reactions of prescription drugs to the FDA. Visit MedWatch at www.fda.gov\/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix Pharmaceuticals (US) by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com<\/a>.<\/p>\n

This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.<\/em><\/p>\n

Legal Notices<\/strong><\/p>\n

Cautionary Statement Regarding Forward-Looking Statements<\/p>\n

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. <\/em><\/p>\n

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. <\/em><\/p>\n

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 \u201cmay\u201d, \u201cexpect\u201d, \u201cintend\u201d, \u201cplan\u201d, \u201cestimate\u201d, \u201canticipate\u201d, \u201cbelieve\u201d, \u201coutlook\u201d, \u201cforecast\u201d and \u201cguidance\u201d, 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\u2019s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix\u2019s 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\u2019s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix\u2019s preclinical and clinical trials, and Telix\u2019s research and development programs; Telix\u2019s ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix\u2019s product candidates, manufacturing activities and product marketing activities; Telix\u2019s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix\u2019s product candidates, if or when they have been approved; Telix\u2019s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix\u2019s expenses, future revenues and capital requirements; Telix\u2019s financial performance; developments relating to Telix\u2019s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix\u2019s business; and the pricing and reimbursement of Telix\u2019s product candidates, if and after they have been approved. Telix\u2019s 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. <\/em><\/p>\n

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 \u00ae or \u2122 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. <\/em><\/p>\n

\u00a92025 Telix Pharmaceuticals Limited. All rights reserved.<\/em><\/p>\n\n

1<\/sup> Prostate-specific membrane antigen.
2<\/sup> Positron emission tomography.
3<\/sup> Please see full Important Safety Information on corresponding pages.
4<\/sup> Telix ASX disclosure 21 March 2025.<\/p>\n

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