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Stealth BioTherapeutics Receives Orphan Drug Designation from the European Medicines Agency for Elamipretide for the Treatment of Barth Syndrome firstwordpharma
June 02, 2021
MITO today announced that the European Medicines Agency (EMA) has granted orphan drug designation (ODD) for elamipretide for the treatment of Barth syndrome, an ultra-rare genetic condition.
FDA Grants Rare Pediatric Disease Designation to Elamipretide for Barth Syndrome americanpharmaceuticalreview
March 05, 2020
Stealth BioTherapeutics announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation for elamipretide for the treatment of Barth syndrome.
Stealth BioTherapeutics Announces Positive Results for Elamipretide in Barth Syndrome Open-Label Extension Trial americanpharmaceuticalreview
April 18, 2019
Stealth BioTherapeutics announced positive results from the open-label extension of the Phase 2/3 TAZPOWER study of elamipretide ...
Stealth BioTherapeutics shoots for $86M IPO to target mitochondrial dysfunction fiercebiotech
January 04, 2019
Stealth BioTherapeutics filed on Friday to raise up to $86 million in its Nasdaq IPO, funding that will push its lead asset through the clinic in multiple indications......
Stealth BioTherapeutics Granted Fast Track Designation for Elamipretide americanpharmaceuticalreview
December 11, 2018
Stealth BioTherapeutics announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead investigational candidate, elamipretide....
Stealth BioTherapeutics Granted Orphan Drug Designation for Elamipretide for Treatment of Barth Syndrome biospace
April 10, 2018
Stealth today announced that the FDA Office of Orphan Products Development has granted Orphan Drug Designation to Stealth's investigational drug candidate, elamipretide, for the treatment of patients with Barth syndrome.