Telix Pharmaceuticals - TLX591-CDx NDA submitted
On 24 September 2020 Telix announced it had submitted its NDA to the FDA for approval of TLX591-CDx, its positron emission tomography (PET) imaging agent targeting prostate-specific membrane antigen (PSMA). The agency has a statutory 12 months to complete its assessment (two to accept the application and 10 to review). TLX591-CDx would be the company’s first approved product and it is in preparations to be ready to launch the product in 2021, which includes establishing distribution and supply-chain relationships.Telix Pharmaceuticals Ltd. Telix Pharmaceuticals Limited is an Australia-based biopharmaceutical company. The Company is focused on development and commercialization of diagnostic and therapeutic products based on radiopharmaceuticals, or molecularly-targeted radiation (MTR). MTR is a novel therapeutic approach that selectively delivers radiation to cells that exhibit certain molecular profiles or targets that may be indicative of cancer. The Company's MTR products such as TLX-250 diagnosis and treatment of renal (kidney), TLX-591 treatment of metastatic castrate-resistant prostate cancer, and TLX-101 treatment of glioblastoma (brain cancer).
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