PRODUCTTLX250-CDx

TLX250-CDx (89Zr-DFO-girentuximab) is a microdose radiopharmaceutical Positron Emission Tomography (PET) imaging agent in development by Telix Pharmaceuticals for the diagnosis of clear cell renal cell carcinoma (ccRCC), the most aggressive and common form of kidney cancer. TLX250-CDx is a radiolabeled form of the antibody girentuximab which binds to the tumor-specific antigen carbonic anhydrase IX (CAIX). Telix initiated a rolling BLA submission for TLX250-CDx in December 2023 and, in February 2025, TLX250-CDx was granted a Priority Review and an August 2025 PDUFA date by the U.S. FDA. If approved, it is expected to be the first targeted radiopharmaceutical imaging agent for the diagnosis of kidney cancer.

Background

HCRx acquired a portion of Heidelberg Pharma’s royalty interest on worldwide net sales of TLX250-CDx. The transaction provides Heidelberg with non-dilutive financing that will extend the company’s cash runway and enable it to accelerate and expand development of its proprietary pipeline of ADC candidates. Under the terms of the agreement, Heidelberg received a $25 million upfront payment at closing. In addition, under a subsequent amendment, the company received a $20 million milestone upon announcement of the PDUFA date and is eligible to receive a $70 million payment upon FDA approval of TLX250-CDx.

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