Stealth hit by FDA rejection to twice-delayed filing as it lays off staff

Stealth BioTherapeutics’ 16.5-month priority review cycle has ended in rejection. After delays, Stealth said the FDA turned down its request but set out a path to accelerated approval, leading the biotech to lay off 30% of its staff to conserve cash for a resubmission.

May 29, 2025 - 14:50
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Stealth hit by FDA rejection to twice-delayed filing as it lays off staff
Stealth BioTherapeutics’ 16.5-month priority review cycle has ended in rejection. After delays, Stealth said the FDA turned down its request but set out a path to accelerated approval, leading the biotech to lay off 30% of its staff to conserve cash for a resubmission.