Key Takeaways Sarepta plans sNDAs to shift Amondys 45 and Vyondys 53 from accelerated to full approval.SRPT will submit real-world and clinical data after a study missed its primary endpoint.SRPT cited COVID-19 impact on results and highlighted favorable safety in the ESSENCE study.Sarepta Therapeutics (SRPT) announced plans to submit supplementary new drug applications (sNDAs) to the FDA for its two RNA-based PMO therapies — Amondys 45 and Vyondys 53 — by the end of next month. These filings seek to conver ...