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Sarepta says FDA accepts AMONDYS 45, VYONDYS 53 sNDAs for review, sets Feb. 28, 2027 PDUFA date

PUBT · 4d ago

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Sarepta says FDA accepts AMONDYS 45, VYONDYS 53 sNDAs for review, sets Feb. 28, 2027 PDUFA date

Sarepta Therapeutics’ sNDAs for AMONDYS 45, VYONDYS 53 accepted by FDA for review to convert accelerated approvals to traditional approvals.
FDA set a PDUFA target action date of Feb. 28, 2027.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Sarepta Therapeutics Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 202606300830BIZWIRE_USPR_____20260630_BW779541) on June 30, 2026, and is solely responsible for the information contained therein.

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