Dyne plans to submit for FDA Accelerated Approval for Duchenne exon 51 skipping in 2026;  Trial still recruiting participants.   

Dyne Therapeutics, which received early funding from CureDuchenne, plans to pursue US Accelerated Approval from the FDA in 2026 for DYNE-251, an exon-skipping experimental therapeutic for individuals with Duchenne amenable to skipping Exon 51.  Data from their ongoing DELIVER trial, expected Q4 2025, will support this submission, and Dyne is currently enrolling participants for an expansion cohort in that trial.

Link to trial: https://clinicaltrials.gov/study/NCT05524883

Link to press release: https://investors.dyne-tx.com/news-releases/news-release-details/dyne-therapeutics-reports-new-clinical-data-showing-compelling