Today, Dyne Therapeutics announced that the company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for zeleciment rostudirsen (z-rostudirsen, DYNE-251) for individuals living with Duchenne who are amenable to exon 51 skipping. Z-rostudirsen is an investigational exon skipping therapy bound to an antigen-binding fragment (Fab) to help the therapy reach the muscle cells for those amenable to exon 51 skipping.

Dyne notes that the submission is supported by data from the Phase 1/2 DELIVER clinical trial. The company is seeking Accelerated Approval from the FDA and has also requested Priority Review. The FDA will now determine whether to accept the application for review and whether either approval pathway will be granted.

Today’s news of Dyne’s BLA submission comes soon after the company announced the initiation of the confirmatory Phase 3 FORZETTO trial of z-rostudirsen. According to Dyne, in addition to z-rostudirsen, the company is advancing four development candidates (DYNE-253, DYNE-245, DYNE-244 and DYNE-255) for the potential treatment of Duchenne amenable to skipping of exons 53, 45, 44, and 55, respectively.

PPMD is encouraged to see continued progress in the development of z-rostudirsen and will continue sharing updates with the community as more information becomes available. We also look forward to hearing updates from Dyne at PPMD’s 2026 Annual Conference, taking place June 25-27, 2026, in Orlando, Florida. Learn more and register for Annual Conference here.

Read Dyne’s press release here.