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Telix Pharmaceuticals has submitted a Biologics License Application (BLA) to the FDA for TLX250-CDx (Zircaix®), a PET imaging agent designed for kidney cancer diagnosis. The drug specifically targets clear cell renal cell carcinoma (ccRCC), the most aggressive form of kidney cancer. If approved, TLX250-CDx will be the first targeted PET agent for kidney cancer available in the U.S. market.
The product has received Breakthrough designation and may qualify for priority review. The company aims for a full U.S. commercial launch in 2025. The FDA will announce the PDUFA goal date following a 60-day administrative review period.
Telix Pharmaceuticals ha presentato una Domanda di Licenza Biologica (BLA) alla FDA per TLX250-CDx (Zircaix®), un agente di imaging PET progettato per la diagnosi del cancro renale. Il farmaco colpisce specificamente il carcinoma renale a cellule chiare (ccRCC), la forma più aggressiva di cancro ai reni. Se approvato, TLX250-CDx sarà il primo agente PET target per il cancro renale disponibile nel mercato statunitense.
Il prodotto ha ricevuto la designazione di Breakthrough e potrebbe qualificarsi per una revisione prioritaria. L’azienda mira a un lancio commerciale completo negli Stati Uniti nel 2025. La FDA annuncerà la data obiettivo PDUFA dopo un periodo di revisione amministrativa di 60 giorni.
Telix Pharmaceuticals ha presentado una Solicitud de Licencia Biológica (BLA) a la FDA para TLX250-CDx (Zircaix®), un agente de imagen PET diseñado para el diagnóstico del cáncer de riñón. El medicamento se dirige específicamente al carcinoma de células renales claras (ccRCC), la forma más agresiva de cáncer renal. Si se aprueba, TLX250-CDx será el primer agente PET dirigido para el cáncer de riñón disponible en el mercado de EE. UU.
El producto ha recibido la designación de Avance y podría calificar para una revisión prioritaria. La empresa tiene como objetivo un lanzamiento comercial completo en EE. UU. en 2025. La FDA anunciará la fecha objetivo PDUFA tras un período de revisión administrativa de 60 días.
Telix Pharmaceuticals는 FDA에 TLX250-CDx (Zircaix®)에 대한 생물학적 제품 허가 신청(BLA)을 제출했습니다. 이는 신장암 진단을 위한 PET 이미징 제제로, 특히 가장 공격적인 형태의 신장암인 투명 세포 신장 세포 암종(ccRCC)을 표적으로 합니다. 승인될 경우 TLX250-CDx는 미국 시장에서 사용할 수 있는 최초의 표적 PET 제제가 될 것입니다.
이 제품은 혁신적인 치료제 지정을 받았으며, 우선심사를 받을 수 있습니다. 회사는 2025년에 미국에서의 전면 상업적 출시를 목표로 하고 있습니다. FDA는 60일의 행정 검토 기간 이후 PDUFA 목표 날짜를 발표할 것입니다.
Telix Pharmaceuticals a soumis une Demande de Licence Biologique (BLA) à la FDA pour TLX250-CDx (Zircaix®), un agent d’imagerie PET conçu pour le diagnostic du cancer du rein. Ce médicament cible spécifiquement le carcinome à cellules claires du rein (ccRCC), la forme la plus agressive du cancer du rein. En cas d’approbation, TLX250-CDx sera le premier agent PET ciblé pour le cancer du rein disponible sur le marché américain.
Le produit a reçu la désignation Breakthrough et pourrait être éligible pour un examen prioritaire. L’entreprise vise un lancement commercial complet aux États-Unis en 2025. La FDA annoncera la date d’objectif PDUFA après une période de révision administrative de 60 jours.
Telix Pharmaceuticals hat einen Antrag auf biologische Zulassung (BLA) bei der FDA für TLX250-CDx (Zircaix®) eingereicht, ein PET-Bildgebungsagent, der zur Diagnose von Nierenkrebs entwickelt wurde. Das Medikament zielt speziell auf das klarzellige Nierenzellkarzinom (ccRCC) ab, die aggressivste Form von Nierenkrebs. Falls genehmigt, wird TLX250-CDx das erste gezielte PET-Mittel für Nierenkrebs sein, das auf dem Markt in den USA verfügbar ist.
Das Produkt hat die Breakthrough-Designierung erhalten und könnte für eine prioritäre Prüfung in Frage kommen. Das Unternehmen plant einen vollständigen kommerziellen Markteintritt in den USA für 2025. Die FDA wird das Zieltermin für PDUFA nach einer 60-tägigen administrativen Prüfungsphase bekannt geben.
Positive
- First-to-market potential in U.S. for targeted kidney cancer PET imaging
- FDA Breakthrough designation obtained, indicating potential priority review
- Planned commercial launch in 2025
- Addresses unmet medical need in ccRCC diagnosis
Negative
- FDA approval still pending
- Revenue generation dependent on successful regulatory review
Insights
<p>The BLA submission for TLX250-CDx represents a <b>pivotal milestone</b> in kidney cancer diagnostics. This PET imaging agent targets carbonic anhydrase IX (CAIX), which is highly expressed in ccRCC tumors. The technology could revolutionize the diagnostic pathway by enabling non-invasive identification of clear cell renal cell carcinoma, potentially reducing the need for invasive biopsies.</p><p>The Breakthrough Designation status significantly enhances the probability of priority review, which could accelerate the approval timeline from 10 months to 6 months. If approved, TLX250-CDx would address a critical gap in kidney cancer diagnosis, where current imaging methods often struggle to definitively characterize renal masses.</p>
<p>This regulatory submission positions Telix to potentially capture a significant market opportunity in kidney cancer diagnostics. With a <money>$5.2 billion</money> market cap, successful commercialization could substantially boost revenue streams, complementing their existing urology imaging portfolio. The targeted 2025 commercial launch aligns with market expectations and provides a clear timeline for investors.</p><p>The first-mover advantage in targeted PET imaging for kidney cancer could establish strong market positioning and pricing power. The diagnostic imaging market for kidney cancer represents a substantial opportunity, considering approximately <b>79,000 new cases</b> of kidney cancer are diagnosed annually in the U.S. alone.</p>
MELBOURNE, Australia and INDIANAPOLIS, Dec. 30, 2024 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) today announces that it has submitted its Biologics License Application (BLA) to the United States (U.S.) Food and Drug Administration (FDA) for TLX250-CDx (Zircaix®1, 89Zr- girentuximab) kidney cancer imaging2.
TLX250-CDx is an investigational PET3 drug product for the non-invasive diagnosis and characterization of clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer. If approved, TLX250-CDx will be the first and only targeted PET agent specifically for kidney cancer to be commercially available in the U.S., further building on Telix’s successful urology imaging franchise.
The FDA is expected to advise the PDUFA4 goal date following the 60-day administrative review of the application.
Kevin Richardson, Chief Executive Officer, Precision Medicine at Telix, stated, “We are pleased to be progressing the BLA for TLX250-CDx, which has been granted Breakthrough designation, and may therefore be eligible for priority review. Telix continues to target a full U.S. commercial launch in 2025 addressing a major unmet medical need for patients with suspected ccRCC.”
About TLX250-CDx
TLX250-CDx (Zircaix®1) is an investigational PET agent that is under development for the diagnosis and characterization of ccRCC. Telix’s pivotal Phase III ZIRCON trial (ClinicalTrials.gov ID: NCT03849118) evaluating TLX250-CDx in 300 patients, of whom 284 were evaluable, met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% positive-predictive value for ccRCC across three independent radiology readers5. Telix believes this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing and characterizing ccRCC. Confidence intervals exceeded expectations amongst all three readers, showing evidence of high accuracy and consistency of interpretation.
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialization of diagnostic and therapeutic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, 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).
Telix’s lead imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)6, by the Australian Therapeutic Goods Administration (TGA) 7, and by Health Canada8. No other Telix product has received a marketing authorization in any jurisdiction.
Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn.
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.
Legal Notices
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 registration statement 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 and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s 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’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation 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; 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.
©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Illuccix® and Zircaix®1 names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.
1 Brand name subject to final regulatory approval.
2 Telix ASX disclosure 31 July 2024. The FDA requested additional data demonstrating adequate sterility assurance during dispensing of TLX250-CDx in the radiopharmacy production environment.
3 Positron emission tomography.
4 Prescription Drug User Fee Act.
5 Shuch et al. Lancet Oncol. 2024. Telix ASX disclosures 7 November 2022.
6 Telix ASX disclosure 20 December 2021.
7 Telix ASX disclosure 2 November 2021.
8 Telix ASX disclosure 14 October 2022.
FAQ
When did Telix (TLX) submit its BLA for TLX250-CDx kidney cancer imaging agent?
Telix submitted its BLA for TLX250-CDx to the FDA on December 30, 2024.
What is the expected launch date for TLX250-CDx in the United States?
Telix is targeting a full U.S. commercial launch of TLX250-CDx in 2025.
What type of cancer does TLX’s TLX250-CDx imaging agent diagnose?
TLX250-CDx is designed to diagnose clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer.
What regulatory designation has TLX250-CDx received from the FDA?
TLX250-CDx has received Breakthrough designation from the FDA, making it potentially eligible for priority review.
Will TLX250-CDx be the first targeted PET agent for kidney cancer in the US?
Yes, if approved, TLX250-CDx will be the first and only targeted PET agent specifically for kidney cancer commercially available in the U.S.
