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.

Mitochondria-targeted therapeutic platform centered on compounds like elamipretide that stabilize cardiolipin in the inner mitochondrial membrane to improve mitochondrial function.

In Barth syndrome, FORZINITY has no direct competitors as the first and only approved therapy. In dry AMD, the competitive landscape is nascent but intense, with many companies pursuing various mechanisms; success would position Stealth against other late-stage candidates in a race to be first-to-market. In the broader mitochondrial medicine field, Stealth is a pioneer, but other biotechs are exploring different approaches to mitochondrial dysfunction.