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Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) has received European approval for Illuccix®, its prostate cancer PET imaging agent. The approval comes through a positive decision on the Marketing Authorization Application (MAA) via a decentralized procedure (DCP), following the Final Assessment Report from the German Competent Authority BfArM.
The approval covers all 18 European Economic Area (EEA) Concerned Member States, with the process now moving to an administrative national phase for individual country launches. PSMA-PET imaging, which Illuccix facilitates, has become the standard of care for prostate cancer management, replacing conventional imaging methods. The technology is recommended in international clinical practice guidelines, including those of the European Association of Urology (EAU) and European Society for Medical Oncology (ESMO).
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) announced that Dr. Christian Behrenbruch, Managing Director and Group CEO, will present at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. The presentation is scheduled for Wednesday, January 15 at 2:15 pm PST (5:15 pm EST / 9:15 am AEDT, January 16). The company has provided registration links for the webcast, which will also be available on-demand on Telix's website after the event.
Telix Pharmaceuticals reported strong Q4 2024 performance with unaudited revenue of approximately US$142 million, marking a 46% increase year-over-year and a 5% increase quarter-over-quarter. The company exceeded its FY2024 guidance with total unaudited revenue of US$517 million, representing a 55% increase over FY2023.
Key developments include the submission of a Biologics License Application (BLA) for renal cancer imaging candidate TLX250-CDx, FDA Priority Review for brain cancer imaging agent TLX101-CDx with a PDUFA date of April 26, 2025, and progress in therapeutic programs including prostate cancer (TLX591), kidney cancer (TLX250), and glioblastoma (TLX101). The company also acquired FAP-targeting assets and completed strategic partnerships, including an AI imaging collaboration with Subtle Medical.
Telix commenced trading on the Nasdaq Global Select Market under symbol 'TLX' in November 2024, while maintaining its ASX listing.
Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) has announced an asset purchase agreement with ImaginAb to acquire next-generation therapeutic candidates and a biologics technology platform. The transaction, valued at US$45 million, includes early-stage drug candidates targeting DLL31 and integrin αvβ62, along with a California-based research facility.
The deal structure comprises US$10 million in cash and US$31 million in equity at closing, with a deferred payment of up to US$4 million in equity after a 15-month indemnity period. Additional milestone payments of up to US$185 million may be paid upon achieving specific development and commercial targets. The agreement also includes royalties in the low single digits on certain platform and early-stage products.
The acquisition will enhance Telix's research capabilities through advanced antibody engineering technology, enabling highly specific cancer targeting with fast tumor uptake and blood clearance potential.
Telix Pharmaceuticals and the Oncidium foundation have published results from the NOBLE Registry study of TLX599-CDx in EJNMMI Reports. The study evaluates a PSMA-SPECT imaging agent for prostate cancer using technetium-99m. Initial results from 40 patients across six countries showed that the imaging led to management changes in 42.5% of cases, with no adverse events reported.
The technology aims to improve access to prostate cancer imaging, as SPECT machines are four times more abundant globally than PET scanners. The study demonstrates that technetium-based PSMA imaging could provide a more accessible alternative to PET imaging, particularly beneficial for patients in remote locations or areas with healthcare resources.
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 has completed the installation of two cyclotrons at its Manufacturing Solutions facility in Brussels South, Belgium. The facility will serve as the company's primary manufacturing site for the EMEA region, with production starting in 2025. One cyclotron will focus on clinical and commercial supply, while the other will be dedicated to R&D activities.
The facility, equipped with GE HealthCare and IBA cyclotrons and ARTMS' QUANTM Irradiation System™, will produce various medical isotopes including gallium-68, zirconium-89, fluorine-18, copper-64, and actinium-225. The company received an updated radiation license in 2022 from the Belgian Federal Agency for Nuclear Control. Commercial GMP production is expected to begin in H2 2025, following commissioning in early Q1 2025.
Telix Pharmaceuticals announces expansion of its theranostic pipeline with new FAP-targeting assets, focusing initially on bladder cancer treatment. The company has entered exclusive worldwide agreements for clinically validated FAP-targeting therapeutic and diagnostic radiopharmaceutical candidates developed at Johannes Gutenberg-Universität Mainz. The assets, tested in over 500 patients, feature enhanced tumor retention and reduced off-target uptake. The deal involves €7 million in initial cash payment, €3 million after 12 months, and up to €132 million in milestone payments, plus €20 million in commercial milestones and royalties.
Telix Pharmaceuticals (ASX: TLX; Nasdaq: TLX) announces the commencement of trading of its American Depository Shares (ADSs) on the Nasdaq Global Select Market under the ticker symbol 'TLX'. Each ADS represents one fully paid ordinary share, with no new shares issued as part of the listing. The company maintains its primary listing on ASX, with JPMorgan Chase Bank appointed as the depositary, custodian and registrar for the ADS program. Initial trading may be as existing shareholders transition their shares to ADSs.
Telix Pharmaceuticals has partnered with Eckert & Ziegler SE for cyclotron-based production of actinium-225, a key isotope for targeted alpha therapies (TATs). The collaboration combines EZAG's isotope technology with Telix's global manufacturing network to enhance production capacity for both development and commercial purposes. Alpha emitters like actinium-225 can deliver concentrated energy to cancer tissue while minimizing damage to surrounding healthy cells. Telix's TAT pipeline includes several clinical-stage candidates: TLX592 for prostate cancer, TLX252 for CAIX-targeting, TLX101 for brain cancer, and TLX300 for soft tissue sarcoma.
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