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BioWorld - Wednesday, April 15, 2026
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Home » PDUFA date miss another disappointing delay for Barth drug
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PDUFA date miss another disappointing delay for Barth drug

April 29, 2025
By Mari Serebrov
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Stealth Biotherapeutics Inc., and, more importantly, patients with Barth syndrome, faced another disappointing delay April 29 when the U.S. FDA kicked its approval decision down the road for Stealth’s elamipretide.
BioWorld Regulatory Cardiovascular Rare disease Small molecule U.S. FDA PDUFA

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