Telix Pharmaceuticals Ltd ADR - TLX STOCK NEWS

Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) announces four presentations at ASCO GU 2025 in San Francisco, showcasing their therapeutic urologic pipeline. The presentations include preliminary data from the CUPID study of TLX592, demonstrating clinical proof-of-concept for their alpha therapy candidate for prostate cancer.

The company will present updates on ProstACT GLOBAL, their Phase 3 trial evaluating TLX591 in PSMA-positive mCRPC patients. Additionally, updates will be provided on the STARLITE-1 and STARLITE-2 trials, investigating TLX250 in combination with immunotherapy for kidney cancer treatment. TLX250 is positioned to be the first CAIX-targeting rADC to market and is advancing toward a pivotal trial in clear cell renal cell carcinoma.

Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its prostate cancer PET imaging agent Illuccix®. The product is approved for detecting and localizing PSMA-positive lesions in adults with prostate cancer.

PSMA-PET imaging has become the standard of care for prostate cancer management, replacing conventional imaging methods. The approval addresses critical supply shortages in the UK and Europe, where increasing demand has caused delays in patient care.

A key advantage of Illuccix is its local production capability using a gallium-68 generator, requiring minimal equipment and time. The product will be distributed in the UK through Telix's exclusive partner, Xiel , improving access to PSMA-PET imaging across metropolitan and non-metropolitan locations.

Telix Pharmaceuticals has completed the acquisition of ImaginAb, securing next-generation therapeutic candidates and a proprietary biologics technology platform. The transaction, valued at US$45 million upfront, includes a pipeline of drug candidates targeting cancer markers DLL3 and integrin αvβ6, along with a research facility in Los Angeles.

The deal structure comprises US$10 million in cash, US$31 million in equity (2,053,311 Telix shares at AU$24.3745), and a deferred payment of up to US$4 million. Additional milestone payments of up to US$185 million may be paid upon achieving specific development and commercial targets. The acquisition brings advanced protein engineering capabilities and a specialized research team to Telix's existing operations.

The technology platform features engineered antibody formats enabling precise cancer targeting with radiation, characterized by rapid tumor uptake and blood clearance. This acquisition enhances Telix's ability to develop next-generation theranostic radiopharmaceuticals.

Telix Pharmaceuticals (ASX: TLX, Nasdaq: TLX) has completed the acquisition of RLS (USA) Inc., America's only Joint Commission-accredited radiopharmacy network. The acquisition, valued at US$230 million upfront with potential additional US$20 million in milestone-based payments, includes a network of over 30 radiopharmacies and more than 100,000 square ft of licensed expansion space.

RLS will operate as a standalone business within Telix Manufacturing Solutions (TMS), joining other key brands like ARTMS, IsoTherapeutics, and Optimal Tracers. The integration enhances Telix's U.S. presence and distribution capabilities, enabling in-house cyclotron manufacturing using ARTMS QUANTM Irradiation System™ technology for radiometal production.

ImaginAb has agreed to sell its next-generation therapeutic candidates, proprietary biologics technology platform, and protein engineering facility to Telix Pharmaceuticals (ASX: TLX; Nasdaq: TXL). Post-transaction, ImaginAb will focus on developing its CD8 ImmunoPET imaging candidate, currently in Phase 2 clinical trials and licensed by multiple pharmaceutical companies for immunotherapy imaging trials. The company will also continue developing its Phase 2 prostate cancer imaging agent.

The transaction validates ImaginAb's minibody platform technology, which will enable Telix to explore new disease areas with radiotherapeutic technology. The CD8 platform development will continue, with multiple pharmaceutical companies already incorporating the technology in their immuno-oncology clinical trials. Jefferies and Stifel, Nicolaus & Company served as financial advisors for the transaction.

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.