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14,812 Results for "stealth biotherapeutics".
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Press Releases
Stealth BioTherapeutics Provides Commercial and R&D Pipeline Update and Outlines 2026 Strategic Priorities
January 6, 2026
·
6 min read
Regulatory
Stealth’s Flight Path Returns to FDA for Rejected Barth Drug
Stealth BioTherapeutics originally submitted elamipretide for approval in January 2024, only to receive a rejection in May of this year. In addition to accepting the biotech’s resubmission, the FDA has promised to take action on the candidate by Sept. 26.
August 21, 2025
·
1 min read
·
Annalee Armstrong
Rare diseases
Stealth Wins Expedited FDA Nod for First-Ever Barth Syndrome Treatment
A decade-long journey has come to an end for Stealth BioTherapeutics and the Barth syndrome community with the first-ever treatment for this uncommon mitochondrial disease. CEO Reenie McCarthy called it a “pivotal victory” that “offers hope for expedited regulatory attention to other ultra-rare diseases.”
September 21, 2025
·
7 min read
·
Heather McKenzie
Press Releases
STEALTH BIOTHERAPEUTICS ANNOUNCES FDA ACCEPTANCE OF ELAMIPRETIDE NDA RESUBMISSION
August 22, 2025
·
3 min read
Press Releases
STEALTH BIOTHERAPEUTICS RESUBMITS NEW DRUG APPLICATION FOR ELAMIPRETIDE FOR THE TREATMENT OF BARTH SYNDROME
August 19, 2025
·
4 min read
Rare diseases
FDA Overruled Reviewers in Approving Stealth’s Barth Syndrome Treatment
According to reporting from Reuters, reviewers at the agency pointed to an inability to differentiate from placebo to justify rejecting the drug, but an FDA office director approved the drug anyway.
November 5, 2025
·
2 min read
·
Dan Samorodnitsky
Press Releases
Stealth BioTherapeutics Announces Mito Assist™ Patient Support Program and Specialty Pharmacy Partnership with AnovoRx to Distribute FORZINITY™(elamipretide) injection
October 10, 2025
·
5 min read
Press Releases
Breakthru Medicine emerges from stealth with $60M Series A for cancer drug development
January 29, 2026
·
3 min read
Press Releases
Stealth BioTherapeutics Announces FDA Accelerated Approval of FORZINITY™ (elamipretide HCl), the First Therapy for Progressive and Life-limiting Ultra-rare Genetic Disease Barth Syndrome
September 22, 2025
·
7 min read
Layoffs
Stealth Cuts 30% of Workforce Following FDA Rejection, Still Eyes Barth Approval
Although the FDA has rejected Stealth’s new drug application for Barth syndrome candidate elamipretide, the agency identified a potential accelerated approval pathway. The company has pared down its staff to conserve resources to fund a potential resubmission.
May 30, 2025
·
2 min read
·
Angela Gabriel
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