Posted by Michael Wonder on 24 Jun 2026
Calico Life Sciences announces fosigotifator granted breakthrough therapy designation by the US FDA for the treatment of vanishing white matter disease
23 June 2026 - Calico Life Sciences today announced that the US FDA granted fosigotifator breakthrough therapy designation for the treatment of vanishing white matter disease.
Fosigotifator, an investigational eIF2B activator, is currently in a Phase 1b/2 clinical trial evaluating its safety, tolerability, pharmacokinetics, and exploratory efficacy following administration in adult, pediatric, and infant subjects with vanishing white matter disease.
