# Sarepta Provides Regulatory Update on AMONDYS 45® and VYONDYS 53®
Canonical URL: https://biopharmsignal.com/news/SRPT/sarepta-provides-regulatory-update-on-amondys-45r-and-vyondys-53r
Ticker: SRPT
Company: Sarepta Therapeutics
Source: Sarepta Therapeutics
Published: 2026-03-19 12:30 EST
Original Source URL: https://investorrelations.sarepta.com
## Summary

– Following feedback from FDA, Company intends to submit supplemental new drug applications to FDA by the end of April 2026 requesting conversion to traditional approval CAMBRIDGE, Mass. --(BUSINESS WIRE)--Mar. 19, 2026-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic

## Article Body
– Following feedback from FDA, Company intends to submit supplemental new drug applications to FDA by the end of April 2026 requesting conversion to traditional approval CAMBRIDGE, Mass. --(BUSINESS WIRE)--Mar. 19, 2026-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic
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