Benzinga | Jul 29, 2021 07:10AM EDT

Fusion Pharma Stock Is Trading Higher As FDA Clears Early-Stage Study For Radiopharmaceutical In Neck, Bladder Cancers

* The FDA has signed off Fusion Pharmaceuticals Inc's (NASDAQ:FUSN) Investigational New Drug (IND) applications for [225Ac]-FPI-1966 (FPI-1966) and imaging agent [111In]-FPI-1967 (FPI-1967).

* FPI-1966 is a targeted alpha therapy (TAT) designed to use vofatamab, a human monoclonal antibody, to target and deliver actinium-225 to tumor sites expressing fibroblast growth factor 3 (FGFR3), a protein overexpressed in multiple tumor types.

* The planned Phase 1 trial will investigate safety, tolerability, and pharmacokinetics and establish the recommended Phase 2 dose.

* Price Action: FUSN shares are up 10.2% at $9.05 during the premarket session on the last check Thursday.

* Related content: Benzinga's Full FDA Calendar