The FDA’s fast track status is intended to accelerate the development and review of therapies targeting serious conditions where medical needs remain unmet. Satellos is currently testing its candidate, SAT-3247, in Phase 2 clinical trials involving both children and adults.

Frank Gleeson, co-founder and chief executive, stated that the FDA’s decision builds upon previous orphan drug and rare pediatric disease designations. These regulatory recognitions provide a significant boost to the company’s ongoing clinical program as it seeks to address the progression of Duchenne muscular dystrophy.