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 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
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