Radiopharm Theranostics (ASX:RAD) has reported a positive pre-Investigational New Drug (IND) meeting with the US FDA for its product F18-pivalate (RAD 101).
The radiopharmaceutical developer said following the FDA's guidance, the company plans to file an IND application for a multi-centre trial during Q3 2023 for imaging brain metastasis.
RAD 101, an imaging agent targeting fatty acid synthetase, aims to monitor cerebral metastasis, with approximately 300,000 patients diagnosed each year in the US.
Radiopharm Theranostics has an exclusive global license for the pivalate platform technology and collaborates with the Imperial College of London for further development.