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).