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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.
Elamipretide Study Does Not Meet Primary Endpoint americanpharmaceuticalreview
December 23, 2019
Stealth BioTherapeutics announced top-line data from the Phase 3 MMPOWER-3 trial evaluating elamipretide for treatment of patients with primary mitochondrial myopathy (PMM).
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....
FDA grants orphan drug designation to elamipretide for LHON europeanpharmaceuticalreview
May 02, 2018
The FDA granted Orphan Drug Designation to elamipretide, for the treatment of Leber’s hereditary optic neuropathy…
US FDA grants fast-track status to Stealth’s elamipretide pharmaceutical-technology
November 30, 2017
The US Food and Drug Administration (FDA) has granted fast-track designation for Stealth BioTherapeutics’ lead candidate, elamipretide, to treat patients with Barth syndrome.