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

Sarepta Therapeutics, Inc.

Sarepta Therapeutics, Inc.

SRPT

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  • 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.


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