Telix Pharmaceuticals (ASX:TLX) received a positive decision on its marketing authorization application in Europe for its imaging product, Illuccix, used in a positron emission tomography scan to detect prostate cancer, according to a Friday filing with the Australian bourse.
The German Federal Institute for Drugs and Medical Devices, issued a final assessment report, confirming that Illuccix should receive marketing authorization from the reference member state and all 18 European Economic Area concerned member states, the filing said.
The regulatory process will now transition into an administrative national phase for commercial launch in each country, according to the filing.
Shares rose 3% in morning trade Friday and earlier hit an all-time high.
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