TLX -15.4%: the oncology company announced that they have pulled an application to market into Europe. The Danish Medicines Agency requested further testing numbers for their manufacturing practices to confirm the safety of Telix’s Illuccix product. The radioactive product is used in prostate cancer imaging and was on track for its first EU sales by mid-2023. The company expects to resubmit the application with the additional requests however they would not put a timeframe on the filing.
TLX is a $1.5bn biotech which has been under significant pressure since it reported for the December quarter primarily because cash reserves had more than halved to just over $22m. The news that it had received regulatory approval for its lead prostate cancer imaging product illuccix is clearly now regarded as old news and its all about commercialisation – the co-founders...
Telix Pharmaceuticals Limited is a radiopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR) to treat cancer. In MTR therapy, a radionuclide is attached to a targeting agent such as a small molecule or antibody. This targeting agent specifically binds to tumors and delivers a radioactive payload in a selective way. The radioactive payload can either be diagnostic (for imaging) or therapeutic, or both. Its lead programs include TLX591-CDx (Illuccix) / TLX591 for diagnosis and treatment of metastatic castrate-resistant prostate cancer, TLX250-CDx/TLX250 for diagnosis and treatment of renal (kidney) cancer, TLX101-CDx / TLX101 for diagnosis and treatment of glioblastoma (brain cancer), and TLX66-CDx (Scintimun) / TLX66 for the treatment of bone marrow conditioning and rare diseases.
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