FORZINITY (elamipretide injection)

About Stealth BioTherapeutics

Stealth BioTherapeutics is a biotechnology company pioneering mitochondria-targeted therapeutics, having achieved a landmark accelerated FDA approval for FORZINITY™ (elamipretide) injection for the ultra-rare Barth syndrome in September 2025. The company is advancing its lead compound in other indications, including dry age-related macular degeneration (AMD), a large market with no approved therapies. Founded in 2006 and headquartered in Newton, Massachusetts, Stealth operates as a public company, transitioning from a development-stage firm to one with its first commercial product.

Therapeutic Areas