Highlights
- RAD, a radiopharmaceutical products developer, has finalised “positive” pre-Investigational New Drug meeting
- The company will file in 3Q 2023 an IND application to initiate a multi-centre trial for imaging brain metastasis
- F18-pivalate (RAD 101) is Radiopharm’s proprietary imaging agent that targets fatty acid synthetase
Australian radiotherapeutics company Radiopharm Theranostics (ASX: RAD) has informed about the completion of a "positive" pre-Investigational New Drug meeting for F18-pivalate (RAD 101). RAD asserts that the positive guidance from the US Food and Drug Administration supports an Investigational New Drug application for clinical trial (Phase 2b/3).
Notably, after the announcement, Radiopharm Theranostics' ASX shares were up over 15% and traded at AU$0.15 at the time of writing on 29 May 2023.
Source: Company update
IND application expected in 3Q
It is pertinent to note that the company holds exclusive global licence for the pivalate platform technology.
Radiopharm has collaborated with Imperial College of London for the development of a therapeutic candidate by using the same mechanism of action.
In its announcement, the company has said that the IND application will be filed in 3Q of this year and the first patient is expected to be dosed by the end of 2023.