• Stealth BioTherapeutics Corp (NASDAQ: MITO) has submitted an elamipretide marketing application to the FDA for Barth syndrome.

• The submission is based on results from the SPIBA-001 Phase 3 Retrospective Natural History Control Trial, which compared data from the TAZPOWER Phase 2/3 trial's open-label portion to match natural history controls.

• SPIBA-001 met its primary and most secondary endpoints, demonstrating elamipretide-mediated improvements in exercise tolerance, strength, and cardiac function assessments.

• Barth syndrome is an ultra-rare genetic condition characterized by cardiac abnormalities often leading to heart failure and reduced life expectancy, recurrent infections, muscle weakness, and delayed growth.

• Related content: Benzinga's Full FDA Calendar

• Yesterday, the United States Patent and Trademark Office issued patents covering elamipretide for Barth syndrome and Barth syndrome-related cardiomyopathy until February 2034.

• Price Action: MITO stock is up 3.42% at $1.21 during the premarket session on the last check Tuesday.

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