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- Telix Pharmaceuticals (TLX) has submitted a clinical briefing package to the U.S. FDA for its prostate cancer treating drug
- The company has also completed the additional manufacturing and product release analytics that were recommended by the FDA
- The new drug targets cell surface prostate-specific antigen that is over-expressed on most prostate cancer cells
- Telix is currently down a 2.80 per cent with shares trading for $1.57 apiece
Telix Pharmaceuticals (TLX) has submitted a clinical briefing package to the U.S. FDA for its first product TLX591-CDx.
This comes after procedural guidance received from its pre-NDA meeting.
Telix has also completed the additional manufacturing and product release analytics that were recommended by the FDA (Food and Drug Adminsitration).
Consequently, the amended Drug Master File (DMF) will be filed with with the FDA during January 2020 as part of Telix’s ongoing NDA (Non-Disclosure Agreement) submission process.
“We have now been able to assemble a complete manufacturing, safety and efficacy package for the NDA submission of our first product,” CEO Dr. Christian Behrenbruch said.
“We expect to be able to inform shareholders in February 2020 whether our clinical package is sufficient to finalise the NDA submission process with the FDA,” he added.
TLX591-CDx is a small molecule-based imaging agent for use with Positron Emission Tomography (PET).
It targets a cell surface antigen called prostate-specific membrane antigen (PSMA) that is over-expressed on most prostate cancer cells.
Prostate cancer is the fourth most common cancer worldwide and in 2018, 1.3 million men were diagnosed with prostate cancer for the first time.
Despite advances in treatments, prostate cancer still accounts for a large number of deaths and in 2018 more than 365,000 men died as a result from it.
Current treatments include palliative care, radiation therapy, prostatectomy and chemotherapy.
Telix is currently down a slight 2.80 per cent with shares trading for $1.57 apiece at 3:59 pm AEDT.
