Sarepta Plans FDA Filings Seeking Full Approval for Two DMD Therapies

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 ...