Telix Pharmaceuticals Ltd. received an FDA complete response letter (CRL) a day after the Aug. 27 PDUFA date for its BLA for radiopharmaceutical renal cancer imaging agent, Zircaix (TLX250-CDx, 89Zr-DFO-girentuximab).
Chinese researchers from Huazhong University of Science and Technology have developed a novel carbonic anhydrase IX (CAIX)-targeting radiotracer, [68Ga]NXK-44, for the imaging of hypoxic tumors and renal cell carcinoma (RCC).
Approximately 90% of all kidney cancers involve renal cell carcinoma, against which researchers are racing to find more effective therapies. One of the major challenges in treating this and other cancers is ensuring that the immune cells that infiltrate the tumor remain activated and mount effective responses.
Researchers from First Affiliated Hospital of Zhengzhou University published results from a study that aimed to investigate the mechanisms by which programmed cell death and mitochondrial function influence prognosis and immunotherapy response in renal cell carcinoma (RCC), and to identify novel therapeutic targets for this disease.
After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.
After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.
After a second round, the U.S. FDA has accepted for review radiopharmaceutical company Telix Pharmaceuticals Ltd.’s BLA for its kidney cancer PET imaging agent, TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab), granting it a priority review with a PDUFA date of Aug. 27, 2025.
Inceptor Bio LLC and Shenzhen Grit Biotechnology Co. Ltd. have established a strategic partnership to advance IB-T101, a CAR T therapy targeting solid tumors.
Scientists from the University of Wisconsin-Madison have reported the discovery of novel carbonic anhydrase IX (CAIX) radioligands for molecular imaging in clear cell renal cell carcinoma (ccRCC).
Nextpoint Therapeutics Inc. has unveiled NPX-372, a novel T-cell engager for solid tumors. NPX-372 is a CD3 bispecific antibody with unique capabilities to redirect T cell-mediated cytotoxicity toward B7-H7-positive tumors such as colorectal carcinoma, non-small-cell lung cancer, renal cell carcinoma and prostate cancer.
