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Stealth BioTherapeutics’ Rare Genetic Disease Treatment Gains Fast Track

There are currently no other FDA-approved treatments for Barth syndrome

The U.S. Food and Drug Administration has granted Fast Track designation to Stealth BioTherapeutics‘ Elamipretide, a treatment for Barth syndrome.   “Fast Track designation is an important milestone which will facilitate Stealth’s efforts to develop an effective treatment for the Barth syndrome patient community, for whom there are currently no FDA-approved therapies,” said Stealth’s chief executive officer, Reenie McCarthy. “We are committed to develo...

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