A day after announcing a $400m convertible bond offering, Telix Pharmaceuticals has had a new drug application (NDA) accepted by the US Food and Drug Administration (FDA) for prostate cancer imaging agent TLX007-CDx. The agency has set a prescription drug user fee act (PDUFA) goal date of 24 March 2025, as per a 24 July press release. Radiopharmaceutical specialist Telix said its objective is to further enhance patient access to prostate-specific membrane antigen (PSMA) PET imaging.
PSMA is a protein specific to prostate cancer cells, and the test can detect increased areas of its uptake in cells by linking it with a radioisotope. The technique is seen as to conventional imaging methods for prostate cancer tracking, but issues with accessibility and regulatory requirements mean many prostate cancer patients do not undergo the scan. Telix’s TLX007-CDx is a so-called “cold kit” to prepare PSMA-PET imaging.
The Australia-based company said the kit can help with PSMA imaging product utilisation at locations that are not close to a nuclear pharmacy, a requirement for many current gallium-68 agents. There are currently around 350-450 certified nuclear pharmacists in the US. operates the largest radiopharmaceutical network in the country.
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