MITO - Stealth stock soars 14% on FDA's orphan drug tag to elamipretide for movement disorder

The U.S. Food and Drug Administration granted orphan drug designation to Stealth BioTherapeutics' (NASDAQ:MITO) elamipretide to treat Friedreich’s ataxia (FRDA). FRDA is a rare genetic, neurodegenerative movement disorder, whose symptoms may include frequent falling, difficulty in walking, slurred speech, foot deformities, and an irregular curvature of the spine, among other things. Elamipretide has already received the FDA's orphan drug status to treat Leber’s Hereditary Optic Neuropathy, primary mitochondrial myopathy and Barth syndrome. The FDA grants orphan drug status to therapies aimed at treating or preventing diseases which affect fewer than 200K people in the U.S. The designation has several incentives, including seven years of market exclusivity for the drug, if approved. MITO +14.04% pre-market to $0.76

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Stealth stock soars 14% on FDA's orphan drug tag to elamipretide for movement disorder