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BioWorld - Thursday, December 25, 2025
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» 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.
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Regulatory
Cardiovascular
Small molecule
U.S.
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PDUFA