Stealth Bio gets FDA adcomm for previously rejected ultra-rare disease drug
The U.S. regulator has granted the troubled biotech a Type B meeting, which are typically used to discuss therapies before a new drug application is filed or in the event of a rejection. Stealth will meet with the agency’s Division of Cardiology and Nephrology to discuss new data that have come to light for the drug, called elamipretide.
Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of...
BOSTON, May 12, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced today that the US Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation to elamipretide for the treatment of patients with Duchenne muscular dystrophy (DMD).
Stealth BioTherapeutics Corp has announced topline data from its Phase 2 ReCLAIM-2 trial evaluating elamipretide in geographic atrophy (GA) secondary to dry age-related macular degeneration.
BOSTON, Feb. 15, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq:MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, announced today that the final patient in its 176-subject, ReCLAIM-2 phase 2 clinical trial for extra-foveal geographic atrophy (GA) associated with dry age-related macular degeneration (AMD) has completed treatment. The Company is developing elamipretide for treatment of extra-foveal GA under U.S. FDA Fast Track designation.
BOSTON, Feb. 8, 2022 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochondrial dysfunction, today announced that the company will have an oral presentation at the upcoming 2022 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference, being held March 13-16, 2022 in Nashville, Tennessee. The presentation showcases data demonstrating a potential relationship between elamipretide and an exon skipping phosphorodiamidate morpholino oligomer (PMO) in the X-linked muscular dystrophy (mdx) mouse model. PMOs are one of the few approved drug classes for the treatment of patients with Duchenne muscular dystrophy (DMD).