Stealth BioTherapeutics
FDA Rejects Stealth BioTherapeutics’ Rare Disease Drug but Leaves Door Open for Accelerated Approval
FDA rejection; Stealth BioTherapeutics; elamipretide; Barth syndrome; rare disease; accelerated approval; muscle strength endpoint; phase 2 trial; regulatory delay
FDA Delays Decision on Stealth BioTherapeutics’ Elamipretide for Barth Syndrome Until April 2025
Barth Syndrome, Elamipretide, FDA Decision, Stealth BioTherapeutics, Drug Approval Delay
FDA Advisory Committee Supports Stealth BioTherapeutics’ Elamipretide for Barth Syndrome Despite Data Concerns
Stealth BioTherapeutics, elamipretide, Barth syndrome, FDA advisory committee, ultra-rare disease, unmet medical need
FDA Raises Concerns Over Stealth BioTherapeutics’ Ultra-Rare Disease Drug Ahead of Advisory Committee Meeting
FDA, Stealth BioTherapeutics, elamipretide, Barth syndrome, ultra-rare disease, advisory committee meeting, drug approval, efficacy concerns
FDA Raises Concerns Over Stealth BioTherapeutics’ Ultra-Rare Disease Drug Approval
Stealth BioTherapeutics, ultra-rare disease, FDA approval, Barth syndrome, elamipretide