Stealth BioTherapeutics Announces Mito Assist™ Patient Support Program and Specialty Pharmacy Partnership with AnovoRx to Distribute FORZINITY™(elamipretide) injection Press Release / October 9, 2025October 9, 2025
Stealth BioTherapeutics Announces FDA Accelerated Approval of FORZINITY™ (elamipretide) injection, the First Therapy for Progressive and Life-limiting Ultra-rare Genetic Disease Barth Syndrome Press Release / September 19, 2025October 6, 2025
STEALTH BIOTHERAPEUTICS ANNOUNCES FDA ACCEPTANCE OF ELAMIPRETIDE NDA RESUBMISSION Press Release / August 21, 2025August 21, 2025
STEALTH BIOTHERAPEUTICS RESUBMITS NEW DRUG APPLICATION FOR ELAMIPRETIDE FOR THE TREATMENT OF BARTH SYNDROME Press Release / August 18, 2025September 18, 2025
Stealth BioTherapeutics Announces “Path Forward” Despite Disappointing Delay for Ultra-rare Barth Syndrome Press Release / May 29, 2025September 24, 2025
Stealth BioTherapeutics Announces Delay in FDA Action Date for Barth Syndrome Application Press Release / April 29, 2025September 24, 2025
Stealth BioTherapeutics to Present New Bevemipretide Data at ARVO Annual Meeting Press Release / April 24, 2025September 24, 2025
Stealth BioTherapeutics Announces Achievement of 50% Enrollment Target in Phase 3 ReNEW Study of Elamipretide in Patients with Dry Age-Related Macular Degeneration Press Release / March 13, 2025September 24, 2025
Stealth BioTherapeutics Announces PDUFA Action Date Extension for Elamipretide to Treat Patients with Barth Syndrome Press Release / January 23, 2025April 14, 2025
