www.fdanews.com/articles/174864-fda-awards-stealth-biotherapeutics-fast-track-for-mtp-131
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FDA Awards Stealth BioTherapeutics Fast Track for MTP-131
January 13, 2016
Stealth BioTherapeutics has scooped up FDA fast track designation for its MTP-131 — also known as Bendavia — for the treatment of primary mitochondrial myopathy.
MTP-131 fights the disease by targeting the inner mitochondrial membrane.
The drug is currently in a Phase 1/2 trial with results expected midyear, the Newton, Mass.-based company says.