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Stealth biotherapeutics is an innovative biopharmaceutical company developing therapies to treat mitochondrial dysfunction associated with genetic mitochondrial diseases and common diseases of aging. Stealth’s commercial product, forzinity, was granted accelerated approval by the u.s Please be aware of the potential for scams claiming to represent stealth biotherapeutics in recruitment activities
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Despite an fda delay, stealth secures a potential “path forward” for elamipretide in barth syndrome, with plans to resubmit nda and explore accelerated approval.
Stealth biotherapeutics announced that the fda cardiovascular and crdac voted 10 to 6 in favor of stealth's new drug application. On january 14, 2025, the fda notified stealth that new analyses requested by fda in late november and early december 2024 required a delay of the pdufa date to april 29, 2025.
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